AMD Medicom Inc
Active in EUDAMEDCanadafrom SRN EUDAMED FDA SRN CA-MF-000052779 FEI 3017425988
- Devices
- 1,565
- Registrations
- EUDAMEDFDA
- FDA recalls
- 75 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
What AMD Medicom Inc makes
AMD Medicom Inc manufactures single-use medical textiles and protective barriers, including surgical and isolation gowns, non-antimicrobial face masks, and nitrile examination gloves. Their portfolio also includes sterilization packaging, radiopaque surgical sponges, and various gauze pads for wound care and procedural use.
The company’s products are regulated under FDA’s Class I and Class II categories, with some devices classified as unlisted (U). These items are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.
Catalogue
Search and filter all 1,565 devicesShowing 1-50 of 1,565
Company details
- EUDAMED SRN
- CA-MF-000052779
- FDA FEI number
- 3017425988
- DUNS number
- 256880576
- EUDAMED status
- Active
- EUDAMED registered name
- AMD Medicom Inc
- Registered address
- 2555, Chemin de l'Aviation, H9P 2Z2, Montreal, Canada
- enquiry@medicom.ca
- Phone
- 1(514)636-6262
- PRRC contact
- Brent Geiger
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 2
- 2020 0
- 2021 0
- 2022 0
- 2023 3
- 2024 0
- 2025 0
- 2026 2
2026
- 8 May 2026 Z-2458-2026 Class II Ongoing Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
- 8 May 2026 Z-2459-2026 Class II Ongoing Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
2023
- 21 Dec 2023 Z-1146-2024 Class II Ongoing Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- 21 Dec 2023 Z-1147-2024 Class II Ongoing Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
- 21 Dec 2023 Z-1148-2024 Class II Ongoing Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
2019
- 11 Oct 2019 Z-0494-2020 Class II Terminated Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.
Full distribution text
- 11 Oct 2019 Z-0495-2020 Class II Terminated Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.
Full distribution text
- 11 Oct 2019 Z-0494-2020 Class II Terminated Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing the risk of using a mask with a lower protection level than intended.
Sites
- AMD Medicom Inc. CAFEI 3002677549 0 devices
Frequently asked questions
How many devices does AMD Medicom Inc have in the registry?
The registry currently lists 1565 devices for AMD Medicom Inc. Devices recorded under merged duplicate company entries are counted once.
Which registries list AMD Medicom Inc's devices?
Among its 50 most recently registered devices, AMD Medicom Inc has devices listed in EUDAMED (11 devices) and FDA GUDID (39 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do AMD Medicom Inc's devices fall under?
Among its 50 most recently registered devices, the classes recorded for AMD Medicom Inc's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for AMD Medicom Inc?
FDA recall records list 7 recalls initiated by AMD Medicom Inc, the most recent initiated on 8 May 2026. 5 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from AMD Medicom Inc in the registry?
The most recently registered devices listed for AMD Medicom Inc include PracticeProtect, MEDICOM DENTICARE 10067, MEDICOM DENTICARE 10068 and MEDICOM 224415.