Skip to content

AMD Medicom Inc

Canada CA-MF-000052779 Last updated 23 Oct 2026

Devices
1,565
Registries
EUDAMEDGUDIDFDA
FDA recalls
75 ongoing

Catalogue1,565

Page 1 of 32

Showing 1-50 of 1,565

FDA recalls7

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 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.via FDA establishment AMD Medicom Inc.
    • 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.via FDA establishment AMD Medicom Inc.

  • 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.via FDA establishment AMD Medicom Inc.
    • 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.via FDA establishment AMD Medicom Inc.
    • 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.via FDA establishment AMD Medicom Inc.

  • 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.via FDA establishment AMD Medicom Inc.
    • 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.via FDA establishment AMD Medicom Inc.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • AMD Medicom Inc. Pointe-Claire, Montreal Quebec · CA FEI 3002677549

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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does AMD Medicom Inc manufacture?

AMD Medicom Inc specializes in single-use medical textiles and protective barriers. Their product range includes surgical and isolation gowns, non-antimicrobial face masks, nitrile examination gloves (non-powdered), sterilization packaging, radiopaque surgical sponges, and various gauze pads for wound care and procedural use. These items are designed for clinical, surgical, and examination settings to ensure patient and staff safety.

Where is AMD Medicom Inc based?

AMD Medicom Inc is headquartered in the United States. While the exact location isn’t specified, the company operates within the U.S. regulatory framework, which governs its medical device portfolio.

Which regulatory registries list AMD Medicom Inc’s devices?

AMD Medicom Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations by assigning a standardized identifier to each product, helping track devices throughout their lifecycle.

How are AMD Medicom Inc’s devices classified under U.S. regulations?

AMD Medicom Inc’s devices fall under FDA’s Class I and Class II categories, with some classified as unlisted (U). Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The unlisted (U) classification indicates devices not previously cleared or approved, requiring additional review.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Canada
Address
2555, Chemin de l'Aviation, Montreal, Canada
Website
medicom.ca
Phone
1(514)636-6262
PRRC contact
Brent Geiger
EUDAMED SRN
CA-MF-000052779
FDA FEI number
3017425988
DUNS number
256880576