Device manufacturer, as written on reports

Medos International Sarl: medical device reports filed with FDA

13,846 reports name it as the manufacturer of the device involved, 2015–2026.

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.

13,846
reports naming it as manufacturer: 0.1% of all MAUDE reports; 2,034
reports, 12 months to August 2026: 1,960 in the 12 months before; 86.1%
classified as malfunction: 62.3% across all reports; 0.7%
classified as death, as reported: 0.9% across all reports

13,846 medical device reports received by FDA give Medos International Sarl as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2015 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

2,034 reports arrived in the 12 months to August 2026, close to the 1,960 of 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 (86.1%), injury (13.2%) and death (0.7%). 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
Cerenovus Enterprise	Intracranial neurovascular stent	1,542	951	0.5%
Prowler Select	Catheter, percutaneous, neurovasculature	744	461	0.1%
Truespan 12 Degree Peek	Fastener, fixation, nondegradable, soft tissue	570	127	0%
Prowler Select Plus 150/5cm	Catheter, continuous flush	370	1	0.2%
Truespan 24 Degree Peek	Fastener, fixation, nondegradable, soft tissue	365	149	0%
Hd Epscp 4 0 30 167 Mitek	Arthroscope	309	27	0%
Truespan Meniscal Repair System Peek 12 Degree	Fastener, fixation, nondegradable, soft tissue	223	0	0%
Truespan Meniscal Repair System Peek 24 Degree	Fastener, fixation, nondegradable, soft tissue	215	0	0%
Enterprise2 4mmx23mm	Intracranial neurovascular stent	177	1	0.5%
Rgdloop Adjustable Stnd	Fastener, fixation, nondegradable, soft tissue	165	81	0%
Truespan 24 Degree Plga	Fastener, fixation, nondegradable, soft tissue	148	56	0%
Hd Arthroscope/Sinuscope 4 0mm X 30 Deg X 167mm Mitek Lock	Arthroscope	134	0	0%
Stent - Vascular Reconstruction	Intracranial neurovascular stent	131	3	9%
4k C-Mnt Scp 4 0 30 167 Mitek	Arthroscope	127	205	0%
Truespan 12 Degree Plga	Fastener, fixation, nondegradable, soft tissue	107	65	0%
Deltapaq - Cerecyte Microcoil	Device, neurovascular embolization	86	0	0%
Camera Head Ac - C-Mount	—	82	25	0%
Deltaplush - Cerecyte Microcoil	Device, neurovascular embolization	76	0	0.3%
Shaver Handpiece 2 0 With Buttons	Arthroscope	76	87	0%
All-In-One Ccu+light Row	Laparoscope, general & plastic surgery	63	75	0%
Truespan Orthocord	Fastener, fixation, nondegradable, soft tissue	55	381	0%
Presidio 10 - Cerecyte Microcoil	Device, neurovascular embolization	45	0	1%
Presidio 18 - Cerecyte Microcoil	Device, neurovascular embolization	44	0	0%
Certas Inlin Vlv Sphn/Unit Cat	Shunt, central nervous system and components	24	0	0.6%
Certas Inlin Vlv Only W/Sphngd	Shunt, central nervous system and components	15	0	0.9%
5 5 Exp Verse Unitized Set Scr	Thoracolumbosacral pedicle screw system	1	11	0%
Prowler Select Microcatheters	Catheter, continuous flush	1	0	1.5%

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
NJE	Intracranial neurovascular stent	2,802	20.2%
KRD	Device, vascular, for promoting embolization	2,655	19.2%
MBI	Fastener, fixation, nondegradable, soft tissue	2,424	17.5%
HRX	Arthroscope	1,412	10.2%
HCG	Device, neurovascular embolization	789	5.7%
QJP	Catheter, percutaneous, neurovasculature	682	4.9%
KRA	Catheter, continuous flush	667	4.8%
MAI	Fastener, fixation, biodegradable, soft tissue	485	3.5%
LXH	Orthopedic manual surgical instrument	379	2.7%
DQY	Catheter, percutaneous	187	1.4%

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

Death0.7%92

Injury13.2%1,828

Malfunction86.1%11,924

Other0%1

Not given0%1

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

Questions about Medos International Sarl reports

How many FDA device reports name Medos International Sarl as manufacturer?

13,846 reports through August 2026, 2,034 of them in the latest 12 months.

Which of its brands appear most often?

Cerenovus Enterprise (1,542), Prowler Select (744), Truespan 12 Degree Peek (570), Prowler Select Plus 150/5cm (370) and Truespan 24 Degree Peek (365).

Which device types does it report on?

intracranial neurovascular stent (20.2%), device, vascular, for promoting embolization (19.2%), fastener, fixation, nondegradable, soft tissue (17.5%) and arthroscope (10.2%).

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.