Index · 892 manufacturers

Device manufacturers named on FDA reports

Manufacturer names as written on MAUDE reports, with 1,000 or more reports. Manufacturers are required to file, so report volume follows the number of devices in use.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Manufacturer	Brands with a page	Reports	Latest 12 months
Dexcom	30	2,505,798	348,790
Medtronic Puerto Rico Operations	30	2,007,381	183,158
Carefusion Sd	21	1,374,105	22,569
Tandem Diabetes Care	30	1,373,250	244,646
Institut Straumann	30	1,209,517	240,860
Nobel Biocare	30	899,062	15,706
Abbott Diabetes Care	30	682,164	334,008
Nobel Biocare G Teborg	23	488,700	268,296
Boston Scientific	30	458,954	70,347
Medtronic Minimed	30	442,554	54,842
Respironics	30	388,198	73,768
Insulet	11	330,394	89,296
Mpri	30	293,091	0
Baxter Healthcare	30	279,141	11,947
Jjgc	30	234,327	78,414
Animas	10	226,625	0
Lifescan Europe A Division Of Cilag Intl	24	223,383	0
St Jude Medical Crm-Sylmar	30	193,385	11,838
Allergan Costa Rica	30	182,554	24,283
Dentsply Implants Manufacturing	30	172,869	38,026
Ethicon Endo-Surgery	30	170,810	9,648
Aizu Olympus	30	169,133	97,228
Ethicon	30	167,721	13,600
Medtronic	30	155,418	61,714
Depuy Orthopaedics US	30	149,624	12,085
Intuitive Surgical	30	148,513	51,610
Nobel Biocare USA	30	143,351	29
Zoll Manufacturing	7	135,801	12,542
Roche Diagnostics	30	130,841	5,702
Mis Implants Technologies	30	127,108	31,426
Mentor Texas	30	118,706	14,322
Carefusion 303	30	115,935	75,907
Philips Medical Systems	30	109,510	1,113
Shirakawa Olympus	30	99,303	43,291
St Jude Medical - Neuromodulation	30	98,256	0
Edwards Lifesciences	30	96,334	10,653
Zoll Medical	28	94,788	5,114
Altatec	29	90,987	16,515
Abbott Vascular	30	90,551	6,808
Unomedical Devices De C V	29	90,316	83,648
Medtronic Med Rel Medtronic Puerto Rico	30	88,060	0
Lifescan	30	87,352	10
Unomedical A/S	30	87,343	49,708
Smith & Nephew	30	85,841	6,481
Dentsply Implants A Division Of Dentsply Ih	30	85,012	5,364
Boston Scientific Neuromodulation	30	84,008	9,942
Zimmer Biomet	30	83,997	8,846
Synthes	30	82,699	12,450
Abbott Medical	30	79,470	19,644
Guidant Crm Clonmel Ireland	30	79,198	0
Thoratec	22	78,106	7,189
Av-Temecula-Ct	30	77,601	0
Heartware	20	77,295	1,963
Biotronik Se & Kg	30	76,593	6,233
Baxter Healthcare - Singapore	30	73,289	0
Medtronic Puerto Rico	30	70,053	0
Covidien	30	66,777	7,914
Medtronic Ireland	30	66,617	6,462
Cpi - Del Caribe	28	64,617	0
St Jude Medical - Neuromodulation Puerto Rico	30	63,993	8,296
Bayer Pharma	1	63,368	447
Beta Bionics	5	63,091	61,174
Anthogyr	30	63,076	14,729
St Jude Medical	30	61,640	74
C R Bard Covington -1018233	30	60,777	8,290
Medtronic Singapore Operations	26	59,588	9,828
Smiths Medical Asd	30	59,484	183
Medtronic Neuromodulation	30	59,218	3,385
Biohorizons Implant Systems	5	58,454	215
Biohorizons	4	57,353	25,612
Davol Sub C R Bard	30	57,177	1
St Jude Medical Cardiac Rhythm Management Division	30	55,536	0
Staar Surgical	29	55,212	2,502
St Jude Medical Crmd	30	54,941	0
Olympus Medical Systems	30	54,779	69
Depuy Orthopaedics	30	54,656	124
Datex-Ohmeda	30	53,973	8,704
Ge Oec Medical Systems Slc	7	53,626	0
St Jude Medical Crm-Sunnyvale	30	53,053	0
Baxter Healthcare - Mountain Home	25	53,010	0
Beckman Coulter	30	51,941	656
Roche Diabetes Care	30	51,667	872
Convatec Dominican Republic	11	49,106	5,900
Invacare Florida Operations	22	48,884	0
Hoya Pentax Tokyo Office	3	48,275	3,015
Depuy Ireland - 9616671	30	47,664	5,071
Covidien North Haven	30	47,664	5
Zimmer	30	47,291	778
Medtronic Puerto Rico Villalba	30	46,144	38,174
Medtronic Europe Sarl	30	46,008	5,360
Cardiac Pacemakers	30	44,368	0
Becton Dickinson	30	44,307	5,236
C R Bard Basd -3006260740	30	44,113	10,411
US Surgical Puerto Rico	24	43,664	0
Medtronic Heart Valves Division	30	43,598	1,447
Abbott	30	43,473	3,929
Depuy Orthopaedics 1818910	30	43,452	0
Depuy International	30	43,430	11
Depuy Synthes Power Tools	30	42,633	0
Stryker Orthopaedics-Mahwah	30	42,446	1,417
Carefusion	30	42,247	288
Ge Oec Medical Systems	17	40,105	5
Baxter Healthcare - Largo	15	38,519	0
Respironics California	15	38,472	0
Bard Peripheral Vascular	30	38,465	3,516
Cochlear	29	37,843	3,686
Fresenius Medical Care North America	22	37,664	9
Boston Scientific - Galway	30	37,538	0
Abiomed	17	37,141	5,300
Cook	30	36,416	1,543
Cyberonics	27	36,257	0
Philips Medical Systems Nederland	12	36,103	11,487
Mdt Puerto Rico Operations	30	35,572	27
Arrow International	30	35,068	3,467
Arthrex	21	34,852	6,868
St Paul	30	34,839	0
Biomet Orthopedics	30	34,530	0
Medtronic Navigation	30	34,350	2,156
Synthes USA	30	34,093	0
Medline Industries	11	33,900	26,850
Implant Direct Sybron Manufacturing	23	32,222	0
W L Gore & Associates	30	31,917	2,876
Medtronic Med Rel	21	31,029	0
Hill-Rom	30	30,771	59
Teleflex Medical	20	29,747	1,154
Datascope	30	29,477	7,719
Stryker Instruments-Kalamazoo	30	29,459	2
S I N Implant System	14	29,415	6,597
Stryker Medical-Kalamazoo	30	29,338	749
Abbott Diabetes Care USA	16	28,135	0
Olympus Winter & Ibe	24	27,809	8,948
Wrights Lane Synthes USA Products	30	27,430	0
Baxter Healthcare Pte	27	26,948	0
Boston Scientific - Maple Grove	30	26,806	0
Boston Scientific - Marlborough	30	26,539	0
Stryker Medical	30	26,331	12
Invacare Taylor Street	30	25,615	9
Depuy Mitek US	30	24,966	3,081
Depuy Synthes Products	30	24,793	264
Biosense Webster	30	24,605	3,533
Advanced Bionics	11	24,515	1,550
Medtronic Sofamor Danek USA	30	24,350	2,175
Neodent - Jjgc	30	23,646	0
Alcon Research - Huntington	30	23,599	2,665
Baxter Healthcare - Irvine	9	23,429	0
Alcon Research - Irvine Technology Center	21	22,924	1,884
Terumo Cardiovascular Systems	23	22,913	489
Zimmer Dental	30	22,716	487
Exactech	14	22,686	1,917
United States Surgical	30	22,288	0
Davis & Geck Caribe	28	22,230	2,901
Physio-Control - 3015876	23	22,181	2,751
Siemens Healthcare Diagnostics	30	21,891	817
Penumbra	26	21,617	441
Encore Medical L P	28	21,566	2,246
Maquet Critical Care	19	21,334	1,844
Philips North America	30	21,282	1,507
Medivance 1725056	14	21,280	1,091
Thommen Medical	30	21,205	2,360
Bard Access Systems	30	21,057	118
Fisher & Paykel Healthcare	24	20,820	4,012
Keystone Dental	19	20,712	1,974
Sofradim Production Sas	22	20,400	1,158
Maquet Cardiovascular	26	20,227	1,116
Hill-Rom Ritter	30	20,128	0
Alcon Research - Houston	12	19,970	7,206
Concord Manufacturing	16	19,793	5
Erika De Reynosa De C V	18	19,641	3,417
Abbott Laboratories	30	19,183	838
American Medical Systems	30	18,892	14
Biomet 3i	22	18,767	384
Coloplast A/S	18	18,702	2,705
Resmed	20	18,369	1,045
Ipg Mfg Switzerland	30	18,336	0
Abbott Medical Optics	24	18,323	0
Med-El Elektromedizinische Geraete	8	17,766	1,260
Medtronic Navigation Littleton	21	17,667	0
Stryker	23	17,604	2,428
Oberdorf Synthes Produktions	30	17,336	0
Physio-Control	23	17,268	28
Bausch & Lomb	23	17,224	35
Depuy International 8010379	30	17,114	0
Becton Dickinson And Bd	24	16,957	1,874
Straight Smile	5	16,950	3,409
Hamilton Medical	11	16,772	746
Zimmer Surgical	15	16,551	1,668
Icu Medical	30	16,487	9,103
Hospira Costa Rica	27	16,397	0
Ethicon Endo-Surgery Cincinnati	30	16,287	0
Sistemas Medicos Alaris De C V	28	15,931	3,792
Micro Therapeutics Ev3	30	15,928	2,416
Agfa Healthcare	4	15,864	0
Adin Dental Implant Systems	28	15,799	8,950
Cordis De Mexico	20	15,522	0
Zoll Circulation	15	15,495	805
Datascope - Mahwah	20	15,285	0
Wright Medical Technology	27	15,059	1,757
Vyaire Medical	14	14,765	442
Becton Dickinson & Sparks	24	14,560	2,704
Ortho-Clinical Diagnostics	24	14,543	486
Zoll Lifecor	8	14,520	0
William Cook Europe	19	14,433	270
Medtronic Xomed	30	14,409	2,026
Covidien Mfg Dc Boulder	23	14,148	0
Wavelight	7	14,028	630
Becton Dickinson Infusion Therapy Systems	19	14,016	1,642
Medos International Sarl	27	13,846	2,034
Stryker Instruments-A Division Of Stryker	30	13,787	1,522
Microport Orthopedics	24	13,267	535
Terumo Medical	23	13,208	1,452
Stryker Endoscopy-San Jose	18	13,026	1,085
Cochlear Bone Anchored Solutions	21	13,023	734
Mdt Powered Surgical Solutions	15	13,005	8,056
Abbott Diagnostics Scarborough	14	12,943	718
Implant Direct Sybron Manufact	13	12,926	6,438
Medacta International	4	12,756	1,387
Depuy International - 8010379	30	12,731	146
Heartsine Technologies	7	12,609	967
Ethicon Endo Surgery Cincinnati	30	12,595	0
Becton Dickinson & Bd	30	12,561	770
B Braun Medical	25	12,488	1,880
Stryker Instruments Kalamazoo	30	12,286	0
Disetronic Medical Systems	19	12,216	0
Quidel	7	12,003	0
Davol Sub C R Bard -1213643	30	12,003	1,592
Amo Puerto Rico Mfg	13	11,842	2,073
Baxter Healthcare - Medina	3	11,705	0
Cordis	30	11,677	212
Johnson & Johnson Surgical Vision	26	11,376	160
Becton Dickinson And	30	11,336	333
Abbott Medical Crm-Sylmar	26	11,302	11,302
Abiomed - 1220648	11	11,181	11,129
Mdt Puerto Rico Operations Juncos	22	11,166	0
Unomedical Um-D	27	11,146	2,862
Alere San Diego	7	11,133	173
Allergan Pleasanton	4	11,050	709
Bayer Healthcare	17	11,031	15
Boston Scientific - Spencer	30	10,997	0
Alcon - Irvine Technology Center	15	10,805	0
Medtronic Puerto Rico Operations Med-Rel	30	10,804	0
Medtronic Milaca	16	10,741	0
Trividia Health	9	10,674	570
Arthrocare	11	10,663	699
Depuy Spine	25	10,567	1,330
Medtronic Mexico S De R L De Cv	30	10,546	7,998
Livanova USA	21	10,393	698
Paltop Advanced Dental Solutions	7	10,379	2,944
Baxter Healthcare Sg	17	10,368	0
Biomet UK	11	10,309	574
Invamex	26	10,156	8
Depuy Ireland 9616671	30	10,088	0
Ge Medical Systems China Wuxi	11	9,935	867
Becton Dickinson Medical Systems	17	9,920	697
Depuy Ireland - 3015516266	23	9,919	3,517
Becton Dickinson & Broken Bow	21	9,914	426
Hologic	13	9,893	1,223
Baxter Healthcare - Cleveland	17	9,700	0
Medtronic Cryocath	17	9,668	1,393
Alcon Laboratories Ireland	27	9,462	2,825
Allergan	30	9,443	50
Smith & Nephew Medical	11	9,343	76
Companion Medical	12	9,314	2,311
Cook Ireland	19	9,278	587
Moog Medical Devices Group	10	9,228	174
Smith & Nephew Orthopaedics	16	9,153	152
Sientra	8	9,068	0
B Braun Surgical	1	8,988	1,117
Atrium Medical	13	8,890	133
Alcon Research - Alcon Precision Device	17	8,888	1,275
Synthes Monument	19	8,871	0
Maquet Cardiopulmonary	14	8,831	748
Abbott Manufacturing	13	8,805	0
Medos International S Rl Ch	21	8,733	736
Convatec	20	8,714	462
Allergan Pringy	23	8,714	48
Prismatik Dentalcraft	12	8,609	2,128
Depuy Intl - 8010379	30	8,587	0
Arrow Intl	20	8,526	0
Aomori Olympus	20	8,423	1,576
Hospira	29	8,409	14
Icu Medical De Mexico S De R L De C V	5	8,406	1,715
Biomet Microfixation	6	8,387	396
Medtronic Navigation Louisville	13	8,331	0
B Braun Melsungen	15	8,326	738
Stryker Orthopaedics Mahwah	18	8,260	0
Synthes Oberdorf	26	8,189	0
Applied Medical Resources	15	8,163	675
Bd Medical - Diabetes Care	14	8,110	1
Aesculap	4	8,032	510
Medtronic Neurosurgery	12	7,964	26
Bayer	4	7,891	0
Stryker Trauma Kiel	8	7,820	0
Cardiac Science	10	7,694	680
Boston Scientific - Costa Rica Coyol	30	7,680	0
Livanova Deutschland	11	7,588	677
Gyrus Acmi	14	7,583	1,521
Depuy Warsaw	30	7,534	0
Senseonics	2	7,445	3,324
Terumo Bct	7	7,432	220
Nihon Kohden	12	7,344	850
Baxter Healthcare - Aibonito	16	7,267	0
Covidien Surgical	27	7,203	6,082
Philips Goldway Shenzhen Industrial	10	7,178	5
Wilson-Cook Medical	22	7,176	651
Roche Insulin Delivery Systems	16	7,069	0
Mmj De Cv Usd	11	7,042	1
Depuy Mitek	16	6,989	0
Boston Scientific - Cork	23	6,977	0
Merit Medical Systems	9	6,935	948
Hill-Rom Batesville	18	6,922	0
Advanced Sterilization Products	11	6,909	5
Cyberonics - Houston	20	6,907	1
Endologix	7	6,897	158
Bd Medical Bd West Medical Surgical	26	6,884	661
Mdt Sofamor Danek Puerto Rico Mfg	30	6,817	0
Stryker Neurovascular Cork	3	6,810	818
Medos International S Rl	20	6,783	1,909
Baxter Hlthcare	3	6,773	0
Alcon Laboratories	28	6,727	31
Nevro	4	6,603	759
Abbvie - Medical Device Center	3	6,498	405
Roche Molecular Systems - Branchburg	6	6,451	521
Microvention	4	6,432	857
Karl Storz Se & Kg	7	6,419	2,888
Fresenius Kabi USA	3	6,407	4,269
Rice Creek Manufacturing	14	6,384	0
Medtronic Mexico	30	6,363	33
Vantive US Healthcare	17	6,353	4,113
Mako Surgical	5	6,275	692
Acumed	3	6,270	802
Bausch + Lomb	18	6,263	272
Ogden Manufacturing Plant	8	6,263	758
Zimvie US	30	6,242	6,240
Abbott Vascular-Cardiac Therapies	19	6,218	0
Plexus Manufacturing Sdn Bhd	22	6,138	0
Philips Medizin Systeme B Blingen	16	6,100	2,323
Cardinal Health	29	6,050	200
Cordis Pr	1	6,015	0
Avanos Medical	6	6,014	1,435
1818910 Depuy Orthopaedics	30	5,978	0
Perfusion Systems	14	5,976	1,892
American Medical Systems San Jose	5	5,948	0
Cordis US	12	5,944	3,480
Cook Endoscopy	19	5,830	0
Angiodynamics	7	5,777	452
Given Imaging	4	5,765	20
Defibtech	2	5,760	2,470
Integra Lifesciences Oh/USA	10	5,753	171
C R Bard Covington	20	5,712	0
Zimmer Manufacturing	9	5,681	301
Synthes Brandywine	14	5,586	0
Edwards Lifesciences Pr	9	5,533	482
Fresenius Vial S	7	5,487	984
Given Imaging Yoqneam	3	5,487	621
Zimmer Biomet Spine	3	5,463	262
Lifescan Europe	26	5,434	38
Becton Dickinson Medical Singapore	10	5,432	111
Ventec Life Systems	1	5,411	870
Alcon Research / Huntington	10	5,407	0
St Jude Medical Crm-Kista	27	5,323	0
Depuy Ireland	30	5,305	818
Conmed	12	5,266	552
Howmedica	6	5,215	0
C R Bard	30	5,145	166
Guidant Cardiac Surgery	8	5,123	0
Sorin Group Italia - Crm Facility	12	5,093	20
Smiths Medical International	28	5,088	9
Angiomed & Medizintechnik Kg	13	5,082	327
Stryker Orthopaedics Cork	11	5,049	0
Baxter International	26	5,015	46
Lumenis	11	4,977	1,186
Biomerieux	1	4,904	8
Depuy France Sas - 3003895575	30	4,889	75
Sofradim Production	13	4,887	7
Medela	9	4,829	40
Tosoh	7	4,816	0
Blue Belt Technologies	6	4,750	240
Depuy Synthes Spine	16	4,727	0
Cordis Cashel	11	4,719	0
Philips Healthcare	23	4,689	0
Icu Medical Costa Rica	7	4,594	1,130
Rice Creek Mfg	30	4,556	5
Codman & Shurtleff	18	4,523	0
Medtronic Sofamor Danek	30	4,520	6
Maquet Sas	6	4,508	245
Ethicon Endo-Surgery - Alb	14	4,480	0
Maquet Cv	12	4,465	0
Sanmina -Sci Systems	9	4,448	0
Bd Infusion Therapy Systems De C V	16	4,444	469
Biosense Webster Juarez	18	4,443	0
Hamilton Bonaduz	3	4,409	0
Becton Dickinson & Franklin Lakes	30	4,401	4,401
Baxter Healthcare - Swinford	13	4,400	0
Stryker Medical Div	30	4,398	0
The Anspach Effort	30	4,372	17
Nellcor Puritan Bennett	11	4,345	0
Cook Biotech	5	4,333	0
Invacare Suzhou	10	4,328	0
Spectranetics	8	4,320	594
Microport Crm	18	4,284	787
Baxter Healthcare - Malta	19	4,281	0
Ponce - Uss	17	4,253	0
Nipro Diagnostics	8	4,241	0
Terumo Ashitaka	8	4,234	338
Argon Medical Devices	6	4,233	222
Tornier S	3	4,222	913
Braun Werk Marktheidenfeld	3	4,219	347
K-C Afc Manufacturing S De R L De C V	6	4,198	81
Abbott Diagnostics Division	9	4,190	0
Sunrise Medical Mpd	5	4,134	0
Immucor	5	4,133	21
Stryker Medical Division	29	4,123	0
North Haven - Uss	18	4,066	0
Zest Anchors	2	4,057	119
Newport Medical Instruments	6	4,041	0
Medtronic Cardiovascular	30	4,038	0
Datascope - Fairfield	12	4,030	0
Telectronics Pacing Systems	8	4,021	0
Guidant Vascular Intervention	17	4,013	0
Tornier	2	4,011	1,239
Ace Surgical Supply	5	3,978	29
Z-Systems	2	3,943	364
Abbott Point Of Care	5	3,933	259
Cardiovascular Systems	4	3,923	331
Cordis Europa	9	3,907	0
Minimed	3	3,898	0
Ascensia Diabetes Care US	8	3,891	85
Syncardia Systems	6	3,890	88
Battle Creek Equipment	4	3,844	0
Medtronic Cardiovascular Galway	16	3,837	0
Covidien Irvine	23	3,837	0
Warsaw Orthopedics	27	3,805	0
Biotronik	30	3,795	1,067
Ev3 Neurovascular	8	3,788	0
Bd Suzhou	8	3,784	5
Mallinckrodt Medical	8	3,770	346
Mentor	20	3,733	28
Nxstage Medical	2	3,722	163
C R Bard Basd	6	3,698	0
Covidien Valleylab	20	3,695	0
Dow Corning	13	3,672	0
Datascope Mahwah	8	3,666	0
Dentsply Implants A Division Of Dentsplu Ih	28	3,591	0
Oscor	11	3,567	274
Biotronik Buelach Switzerland	0	3,561	0
Covidien Formerly Ussc Puerto Rico	17	3,523	0
Zimmer Orthopaedic Mfg	4	3,518	590
Ellume	2	3,514	0
Inspire Medical Systems	5	3,480	988
Christoph Miethke & Kg	1	3,468	419
Icu Medical Healthcare Manufacturing De C V	17	3,463	3,428
Boston Scientific Ireland	24	3,430	0
Ethicon Endo-Surgery De C V	7	3,426	0
Cordis Neurovascular	7	3,423	0
Biotronik And	17	3,418	0
Zyno Medical	8	3,379	918
St Jude Medical Neuromodulation	30	3,375	0
Bioenterics	3	3,362	0
Masimo	6	3,342	9
Smiths Medical	30	3,341	0
Genzyme Biosurgery Ridgefield	6	3,326	0
American Heyer-Schulte	5	3,312	0
Amo Manufacturing USA	13	3,291	304
Aga Medical	8	3,289	0
Stryker Endoscopy San Jose	10	3,272	0
Nova Biomedical	6	3,254	58
Becton Dickinson Ind Cirurgicas Ltda	12	3,245	214
Abbott Molecular	4	3,230	182
Advanced Neuromodulation Systems	27	3,226	0
Smiths Healthcare Manufacturing De C V	24	3,167	403
Alcon Research /Huntington	11	3,164	0
Sorin Group Deutschland	10	3,141	0
Applied Medical	14	3,131	0
Medtronic Physio-Control	11	3,129	0
J T Posey	5	3,124	0
Core-Vent Bio-Engineering	5	3,108	0
Depuy France Sas 3003895575	30	3,049	0
Covidien Formerly US Surgical A Divison	14	3,041	0
Invacare Rehabilitation Equip	20	3,036	0
Covidien Juarez Mmj	7	3,036	1,321
Amo Manufacturing Netherlands	6	2,986	788
Mindray Ds USA	8	2,975	0
Medtronic Puerto Rico Operations Juncos	30	2,947	28
Warsaw Orthopedic	24	2,934	163
K2m	4	2,914	335
Verathon Medical Ulc	3	2,876	166
Becton Dickinson Caribe	9	2,873	381
Tambrands Manufacturing	1	2,873	363
Depuy Cmw - 9610921	12	2,861	106
Ebi	5	2,842	155
Alcon Laboratories /Huntington	9	2,831	0
Guidant Endovascular Solutions	5	2,820	0
Cordis Santa Clara	7	2,809	0
I-Flow	8	2,802	0
Conformis	3	2,794	5
Remote Diagnostic Technologies	4	2,792	767
Abbott Vascular - Redwood City	5	2,785	0
Abbott Ireland Diagnostics Division	8	2,785	878
Depuy-Raynham A Division Of Depuy Orthopaedics	20	2,781	0
Covidien Formerly Nellcor	2	2,780	0
Nuvasive	3	2,779	167
Sign Fracture Care International	2	2,765	278
Cameron Health	4	2,762	4
Medtronic-Chengdu	2	2,762	1,534
Unomedical S R O	12	2,758	608
Synthes Bettlach	17	2,756	0
Greatbatch Medical	8	2,748	89
Asahi Intecc	1	2,742	310
Biomet France R L	2	2,737	70
Medex	8	2,727	0
Medcomp	1	2,714	0
Zimmer Spine	3	2,711	0
Abbott Germany	15	2,709	0
Apollo Endosurgery	8	2,678	172
Establishment Labs	1	2,678	1,748
Oakdale	9	2,675	0
Thoratec Switzerland	5	2,669	337
Mhc Medical Products	3	2,664	0
Synthes Hagendorf	16	2,657	0
Neuro - Villalba	21	2,656	0
Noris Medical	5	2,652	816
Quickie Designs	5	2,639	0
Teleflex	12	2,619	95
Ge Medical Systems China	10	2,588	2,516
Onkos Surgical	2	2,582	553
Stryker Spine Bordeaux	2	2,578	0
Medtronic Cardiac Rhythm Management Division	21	2,576	0
Tiger Aesthetics Medical	1	2,576	1,745
Kinetic Concepts	5	2,574	51
Biomet	2	2,565	10
Pringy	18	2,564	1,352
Clearstream Technologies	6	2,549	342
Stryker Osteosynthesis Kiel	3	2,540	0
Stryker Spine-France	3	2,520	0
Coopersurgical	5	2,508	145
Globus Medical	5	2,506	307
Accessclosure	7	2,496	0
Masimo - 40 Parker	5	2,491	0
Alaris Medical Systems	13	2,489	0
Tissue Science Laboratories	13	2,473	0
Hill-Rom Pluvigner	5	2,439	0
Depuy-Cork A Division Of Depuy Orthopaedics	30	2,433	0
Codman And Shurtleff	18	2,433	0
Valleylab	17	2,423	0
Stryker Spine-US	4	2,423	193
Covidien Mfg Solutions	5	2,404	0
Arjohuntleigh Polska Sp Z O O	8	2,388	224
Biosite	5	2,380	0
Abbott Diabetes Care UK	9	2,358	0
Puritan Bennett	5	2,351	0
St Jude Medical Puerto Rico	16	2,351	0
Pride Mobility Products	3	2,349	115
Integra Lifesciences Switzerland Sar	7	2,340	82
Conmed Linvatec	2	2,325	0
Invacare	30	2,308	2
Depuy Intl	30	2,307	0
Welch Allyn Protocol	7	2,304	0
Siemens Medical Solutions USA	9	2,292	70
Bd Rapis Diagnostics Suzhou	10	2,292	282
Guidant Puerto Rico	30	2,286	0
Medtronic Cardiovascular Santa Rosa	30	2,265	0
Torax Medical	6	2,260	137
Halyard Health	5	2,256	0
Therakos	3	2,244	6
Covidien Medical Products	25	2,224	119
Cpi Plant - St Paul	20	2,219	0
St Jude Medical - Cardiomems	7	2,202	0
Integra Lifesciences	13	2,200	53
Abbott Vascular-Vascular Solutions	18	2,200	0
Lumiradx UK	1	2,197	0
Abbott Vascular Redwood City	5	2,187	0
Sharp Osaka Japan	2	2,186	0
Ethicon Endo Surgery	30	2,183	0
Eli Lilly And	3	2,175	49
Zimmer Switzerland Manufacturing	4	2,164	0
Mentor Worldwide	13	2,155	28
Smith & Nephew Orthopaedic Div	8	2,145	0
Olympus Winter & Ibe Berlin Facility	3	2,132	711
Moog Device Group	4	2,129	0
Stryker Leibinger Freiburg	2	2,111	219
Synthes Elmira	2	2,099	0
Reynosa Manufacturing	8	2,092	0
Ge Medical Systems	6	2,091	37
Bd	26	2,086	4
Siemens Healthcare Diagnostics - Glasgow	9	2,079	0
Spacelabs Healthcare	4	2,077	209
Natus Medical	4	2,068	159
Invacare Rehabilitation Equipment	15	2,068	0
Medtech	3	2,064	0
Rayner Intraocular Lenses	3	2,062	362
Sorin Crm	10	2,059	0
Allegiance Healthcare	3	2,057	0
Dentsply Professional	3	2,048	0
Sulzer Calcitek	0	2,040	0
A I D D Longford	10	2,027	0
Dentsply	1	2,020	708
Codman & Shurtleff / Medos	11	2,016	0
Sulzer Orthopedics	1	2,014	0
Kerr	5	2,008	0
Haemonetics	2	1,985	0
Philips Medical Systems Cleveland	4	1,985	0
Allergan Irvine	7	1,984	115
Pulmonetic Systems	2	1,979	0
Lemaitre Vascular	2	1,976	389
Boston Scientific - Fremont Sud	6	1,976	0
Depuy Intl 8010379	30	1,972	0
Carefusion 203	8	1,967	0
Imtmedical	1	1,967	0
Biosense Webster Irwindale	14	1,956	0
Terumo Cardiovascular System	17	1,956	0
Lake Region Medical	9	1,953	311
Stryker Orthopaedics Limerick	6	1,952	0
Alcon Laboratories / Huntington	9	1,948	0
Integra Lifesciences Ireland	6	1,947	108
Boston Scientific - Costa Rica Heredia	11	1,943	0
Lifecore Biomedical	4	1,940	17
Medical Engineering	9	1,937	0
Bard Shannon	12	1,937	0
Cue Health	1	1,922	0
Quanta System	2	1,917	12
Philips Respironics	30	1,908	0
Perclose	6	1,895	0
Bolton Medical	4	1,883	229
Liebel-Flarsheim	0	1,881	15
Sorin Group Italia	8	1,880	59
Bieffe Medital Manufacturing R L Tunis	10	1,874	0
Medtronic Advanced Energy	5	1,874	0
Philips Ultrasound	5	1,865	485
Ge Healthcare	24	1,864	0
Medtronic Heart Valve Division	24	1,864	0
Pacesetter	25	1,863	0
Flowonix Medical	4	1,856	8
Hoya Surgical Optics	2	1,850	76
Ev3	7	1,844	6
Medtronic Dominicana	11	1,841	731
Siemens Healthcare Diagnostics Products	4	1,838	93
Hemosense	2	1,836	0
Depuy Orthopaedic 1818910	30	1,831	0
Mcghan Medical	13	1,829	0
Obtech Medical Sarl	6	1,829	0
Alphatec Spine	4	1,828	261
Ranir	2	1,826	0
St Jude Medical Costa Rica Ltda	21	1,822	0
Integra Lifesciences Mansfield	7	1,807	334
Infutronix	3	1,800	0
Medtronic Heart Valves	15	1,793	0
Alcon Lensx	2	1,784	73
Bd Suzhou Mds	1	1,783	511
Baxter Healthcare - Cartago	20	1,782	0
Dentsply Maillefer	8	1,779	0
Terumo	15	1,775	92
Cardinal Health 200	12	1,775	515
Mdt Puerto Rico Operations Med Rel	30	1,771	523
Ussc Puerto Rico	20	1,770	0
Medisense	3	1,766	0
Covidien Formerly Nellcor Puritan	1	1,763	0
Becton Dickinson Industrias Cirurgicas Ltda	4	1,758	227
Datascope Fairfield	11	1,753	0
Limacorporate	4	1,750	370
St Jude Medical Cardiac Rhythm Management Divisi	17	1,747	0
Nuvasive Specialized Orthopedics	4	1,740	29
Ethicon Sarl	18	1,739	0
Liko	2	1,730	0
Siemens Healthcare	3	1,712	11
Vascular Solutions	3	1,709	66
Baxter Healthcare - Cali	12	1,709	0
Abbott Diagnostics Division/Celldyn	5	1,707	0
Bio-Detek	3	1,701	183
Covidien Shanghai	12	1,699	0
Unomedical Sdn Bhd	3	1,696	0
Baxter Healthcare - Guangzhou	3	1,693	0
Consolidated Medical Equipment	2	1,691	39
Depuy Raynham	19	1,689	0
Orthofix	0	1,681	125
Depuy France	29	1,677	0
Stryker Neurovascular-Utah-Salt Lake City	3	1,664	196
Productos Para El Cuidado De La Salud -9611590	11	1,663	0
Axonics Modulation Technologies	1	1,661	1,021
Irhythm Technologies	3	1,651	336
Steri-Oss	1	1,647	0
Ciba Vision	6	1,646	51
Access Dental Lab	1	1,640	0
Dentsply Vdw	6	1,639	0
Danyang Maxthai Medical Equipment	10	1,637	0
Acon Laboratories	2	1,629	341
St Jude Medical - Spinal Modulation	8	1,628	0
Surgical	3	1,628	1,612
Kimberly-Clark	9	1,622	0
Essential Medical	3	1,618	68
Saluda Medical	4	1,614	665
Ross Products Division	3	1,602	0
Alcon - Irvine Technology Ctr	14	1,600	0
Micro Typing Systems	3	1,600	0
Steris - Montgomery	2	1,600	0
Dentium USA	2	1,592	147
1219655 Depuy-Raynham A Div Of Depuy Orthopaedic	30	1,592	0
Becton Dickinson And Bd Biosciences	1	1,590	14
Philips Oral Healthcare	3	1,582	90
Masimo - 15750 Alton Pkwy	7	1,582	666
Roche Health Solutions	14	1,576	0
Stryker Endoscopy	14	1,574	48
Davol	26	1,560	3
American Medical Systems Innovation Center - Silicon Valley	6	1,558	0
Pfizer Consumer Health Care	4	1,549	0
Keymed Medical And Industrial Equipment	6	1,548	329
Cardinal Health Santa Clara	6	1,546	162
Depuy International -8010379	30	1,535	0
Depuy Orthopaedics US 1818910	30	1,532	0
8010379 Depuy Intl	30	1,527	0
Glaukos	4	1,526	125
Boston Scientific - Costa Rica	13	1,523	0
Ditron Dental	2	1,521	89
3m Health Care	1	1,517	0
Ideal Implant	2	1,514	0
Micrus Endovascular	5	1,513	0
Alcon Grieshaber	4	1,505	248
9616671 Depuy Ireland	30	1,505	0
Bio-Rad Medical Diagnostics	1	1,489	31
Dentsply Implantss A Division Of Dentsply Ih	30	1,486	0
Covidien/Formerly Tyco Healthcare	9	1,482	0
Cryolife	4	1,481	0
Teleflex Medical Sdn Bhd	2	1,480	97
Biosil	2	1,475	0
Arjo Hospital Equipment	8	1,473	15
Rxsight	2	1,469	564
Volcano	1	1,466	211
Stryker Instruments	30	1,463	78
Stanmore Implants Worldwide	0	1,463	0
Ascension Orthopedics	2	1,461	146
Sterilmed	12	1,461	38
Procept Biorobotics	2	1,459	252
Depuy Cmw 9610921	12	1,456	0
Cardioquip	1	1,449	302
Arizona Device Manufacturing	8	1,447	0
Puritan-Bennett	4	1,443	0
International Technidyne	1	1,443	0
Hillrom De Mexico S De Rl De Cv	9	1,440	0
Steris Mexico S De R L De C V	3	1,433	92
Arjohuntleigh Magog	6	1,430	122
Treace Medical Concepts	1	1,425	281
3m	4	1,415	168
Leica Biosystems Melbourne	1	1,405	35
Mentor - Minnesota Division	7	1,404	0
Baylis Medical	5	1,402	2
Livanova Canada	3	1,401	0
Synthes Selzach	10	1,392	0
Farapulse	7	1,392	279
Olympus Medical System	17	1,390	0
Medtronic Emergency Response Systems	13	1,386	0
Nalu Medical	1	1,384	195
Dentsply Tulsa	5	1,383	0
Bausch & Lomb Surgical	6	1,380	0
Boston Scientific - Fremont Ce	8	1,378	0
Therasense	9	1,376	0
Karl Leibinger Medizintechnik & Kg	7	1,370	0
Ldr M Dical	0	1,370	0
Embecta Penel - Dun Laoghaire Ireland	3	1,370	139
Bd Caribe	9	1,366	72
Bard	11	1,360	0
Kci USA	4	1,360	13
Covidien Formerly US Surgical	16	1,357	0
Ferno-Washington	1	1,355	103
Silk Road Medical	3	1,354	216
Baylis Medicale Cie	5	1,348	555
Stryker Osteosynthesis Freiburg	0	1,343	0
Guidant Angleton/St Paul	8	1,343	0
Quidel Ortho-Clinical Diagnostics	5	1,343	211
Zimmer Tmt	3	1,340	67
The Spectranetics	6	1,338	0
Kestra Medical Technologies	2	1,334	733
Medtronic Perfusion Systems	6	1,322	39
Omnilife Science	4	1,321	59
Pip	2	1,308	0
Arkray	5	1,296	0
Glaxosmithkline	3	1,289	0
Deroyal Industries	3	1,288	50
Cordis Miami	4	1,284	0
Si-Bone	1	1,277	0
Solta Medical	4	1,274	41
Ortho Clinical Diagnostics	15	1,273	0
American Medical Systems Mn	9	1,273	0
Mazor Robotics	3	1,273	243
Stryker Ireland	2	1,269	0
Gambro Healthcare	1	1,265	0
Optonol	2	1,263	8
Depuy Ireland Reg 9616671	30	1,262	0
Depuy-Raynham A Div Of Depuy Orthopaedics	23	1,261	0
Kenstone Metal	9	1,261	0
Tulsa Dental Products	1	1,257	121
Gambro Dialysatoren	7	1,254	0
Mallinckrodt Manufacturing	2	1,254	73
Sulzer Intermedics	9	1,249	0
Smith S Medical Asd	21	1,248	0
Steris	6	1,239	236
Medtronic Ave Peripheral Division	3	1,239	0
Stryker Medical London Chg Hospital Beds	4	1,238	0
St Jude Medical - Neuromodulation Division	26	1,235	0
Paragon 28	2	1,230	494
Vistakon	4	1,228	0
Conceptus	1	1,227	0
Stryker Endoscopy Puerto Rico	4	1,224	0
Ethicon San Angelo	8	1,223	0
Medtronic Spine	2	1,220	0
Ok Biotech	2	1,218	13
Guidant Clonmel Ireland	11	1,212	0
Becton Dickinson De Mexico	19	1,212	92
Abbott Ireland	3	1,211	0
Novo Nordisk A/S Medical Systems	4	1,207	79
Nissho	2	1,206	0
Pulmonx	2	1,204	95
Olympus Medical Systems Hinode Plant	15	1,200	258
Covidien Formerly Tyco Healthcare	8	1,199	0
Medtronic Vascular	28	1,198	44
St Jude Medical Cardiac Rhythm Management D	21	1,197	0
Integra Neurosciences Pr	1	1,196	31
Kimberly-Clark - Conway Mill	7	1,195	0
Ela Medical	13	1,191	0
Welch Allyn	6	1,191	89
Storz Instrument	3	1,184	0
Philips / Respironics	13	1,184	13
Linvatec	5	1,180	0
Hill-Rom De Mexico S De Rl De Cv	13	1,180	0
Baxter Healthcare Round Lake	8	1,180	0
Lacey Manufacturing	2	1,179	0
Microtyping Systems	2	1,175	19
Horizon Medical Products	4	1,174	0
Synovis Surgical Innovations	4	1,168	0
Merge Healthcare	3	1,168	7
Vdw	5	1,164	322
Quest Medical	0	1,160	24
Stryker Sustainability Solutions Lakeland	2	1,153	0
Biom Rieux	0	1,144	17
Reshape Lifesciences	1	1,142	1
Dade Behring	3	1,140	0
Concentric Medical	1	1,139	0
Intra-Lock International	5	1,135	106
Philips Electronics Nederland	4	1,131	1
Genteel Homecare Products	7	1,128	0
Abbott Spine	3	1,127	0
Tosoh Hi-Tec	4	1,121	174
Synthes Mezzovico	2	1,118	0
Tandem Diabetes	3	1,117	0
Agilent Technologies	11	1,114	0
Draeger Medical Systems	10	1,113	54
Steris Canada	3	1,109	53
Advanced Medical Optics	6	1,103	0
Richard Wolf	1	1,098	93
Depuy Cmw	16	1,095	0
Q Core Medical	3	1,093	0
Codman & Shurtleff Medos	9	1,092	0
Howmedica Osteonics	3	1,089	10
Maillefer Instruments Holding Sarl	0	1,088	226
Fresenius USA	8	1,085	0
Nakanishi	2	1,083	103
Johnson & Johnson Medical Suzhou	26	1,080	679
Caldera Medical	10	1,077	238
Celestica De Monterrey De C V	6	1,077	0
Merz North America	6	1,072	11
Raynham	10	1,072	0
Houston	15	1,072	817
Smith & Nephew Endoscopy Division	1	1,071	0
Invatec	11	1,071	0
Abbvie Medical Device Centre	3	1,071	0
Lifecell	3	1,070	73
Hill-Rom Mexico	11	1,068	0
Dymax -2523003	5	1,067	0
Fx Solutions	2	1,065	0
Chattem	1	1,064	0
Medtronic Midas Rex	2	1,060	0
Conmed Electrosurgery	2	1,060	0
Straub Medical	1	1,059	459
Maquet	17	1,052	87
Genzyme Ridgefield	6	1,052	20
Q-Med	3	1,051	153
Atricure	0	1,049	64
Pt Ciba Vision Batam	5	1,048	352
Olympus Optical	1	1,047	0
Core-Vent	4	1,046	0
Lucira Health	1	1,039	0
Draeger Medical	14	1,034	0
Stryker Osteosynthesis Selzach	3	1,034	0
Oticon Medical	1	1,031	73
Covidien - Superdimension	7	1,025	119
Resporinoc	30	1,023	0
Heart Valves Santa Ana	30	1,018	0
Power Medical Interventions	1	1,014	0
Neuravi	1	1,011	129
Varian Medical Systems	4	1,009	16
Valeritas	1	1,009	0
Carroll Healthcare	8	1,007	0
Megadyne Medical Products	1	1,003	59
Ge Medical Systems India Private	2	1,000	0

Ordered by report count for navigation only. FDA states that the medical device reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.