Device manufacturer, as written on reports

Stryker Medical-Kalamazoo: medical device reports filed with FDA

29,338 reports name it as the manufacturer of the device involved, 2013–2026.

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.

29,338
reports naming it as manufacturer: 0.1% of all MAUDE reports; 749
reports, 12 months to August 2026: 1,330 in the 12 months before; 95.7%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

29,338 medical device reports received by FDA give Stryker Medical-Kalamazoo as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2013 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

749 reports arrived in the 12 months to August 2026, down 44% from 1,330 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (95.7%), injury (3.9%) and death (0.4%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Secure 3 Med/Surg Bedobs 01/13	Bed, ac-powered adjustable hospital	1,326	8	0.1%
In Touch Zu	Bed, ac-powered adjustable hospital	1,117	0	0.1%
Power Pro Ambulance Cot	Stretcher, wheeled	987	0	0.4%
Stair Pro - Model 6252	Stretcher, hand-carried	837	16	0%
Cub Pediatric Crib- Hyd Base	Bed, pediatric open hospital	783	15	0%
S3 Ex - 3005	Bed, ac-powered adjustable hospital	726	12	0.6%
Sm204 M-Series W/Big Wheel	Stretcher, wheeled	677	7	0%
Power Pro Ambulance Cot - Obs	Stretcher, wheeled	657	11	1.4%
Unknown_Medical_Product	Stretcher, wheeled	644	34	2.2%
Ld304 Maternity Bed	Table, obstetrical, ac-powered (and accessories)	487	10	0%
Sm104 Mseries W5th Whlobs3/07	Stretcher, wheeled	436	5	0.4%
Sm304 M-Series W/Zoom	Stretcher, wheeled, powered	395	0	0%
Bed InTouch with Zoom motor	Bed, ac-powered adjustable hospital	386	13	1%
Power Load	Stretcher, wheeled	382	8	1.5%
Gobed+	Bed, ac-powered adjustable hospital	282	0	0%
Prime 5th Wheel Stretcher 26	Stretcher, wheeled	273	9	0%
Advantage Series 26 Obs 10/04	Stretcher, wheeled	267	1	0%
Prime Zoom Stretcher Electric	Stretcher, wheeled, powered	256	14	0%
Mx-Pro R-3 Ambulance Cot	Stretcher, wheeled	236	4	1.5%
Prime Zoom Stretcher30inlitter	Stretcher, wheeled, powered	205	14	0%
Zoom Critical Care Bed	Bed, ac-powered adjustable hospital	195	0	0.1%
Gynnie Ob-Gyn Stretcher	Stretcher, wheeled	194	11	0%
Prime Big Wheel Stretcher 30	Stretcher, wheeled	190	21	0%
In Touch Eu	Bed, ac-powered adjustable hospital	189	0	0%
Electric Med/Surg Bed	Bed, ac-powered adjustable hospital	187	0	0.3%
Eye Surgery Stretcher	Stretcher, wheeled	184	15	0%
M-1 Cot - Base High Load 28	Stretcher, wheeled	173	2	0%
Altrix Domestic	System, thermal regulating	171	0	0%
Secure Acute Care Bed 3/01	Bed, ac-powered adjustable hospital	162	0	0%
Primebig Wheel Elect Stretcher	Stretcher, wheeled	158	0	0%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
FNL	Bed, ac-powered adjustable hospital	12,237	41.7%
FPO	Stretcher, wheeled	10,836	36.9%
INK	Stretcher, wheeled, powered	1,242	4.2%
FMS	Bed, pediatric open hospital	1,014	3.5%
FPP	Stretcher, hand-carried	934	3.2%
HDD	Table, obstetrical, ac-powered (and accessories)	570	1.9%
DWJ	System, thermal regulating	392	1.3%
IKY	Mattress, flotation therapy, non-powered	307	1%
IKZ	Bed, patient rotation, powered	240	0.8%
FZM	Stool, operating-room	232	0.8%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.4%105

Injury3.9%1,146

Malfunction95.7%28,087

Other0%0

Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Stryker Medical-Kalamazoo reports

How many FDA device reports name Stryker Medical-Kalamazoo as manufacturer?

29,338 reports through August 2026, 749 of them in the latest 12 months.

Which of its brands appear most often?

Secure 3 Med/Surg Bedobs 01/13 (1,326), In Touch Zu (1,117), Power Pro Ambulance Cot (987), Stair Pro - Model 6252 (837) and Cub Pediatric Crib- Hyd Base (783).

Which device types does it report on?

bed, ac-powered adjustable hospital (41.7%), stretcher, wheeled (36.9%), stretcher, wheeled, powered (4.2%) and bed, pediatric open hospital (3.5%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

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