AMD Medicom Inc

Canada Last updated 25 Oct 2026

Devices: 1,565
Registries: EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls: 75 ongoing

Catalogue1,565

Page 32 of 32

Medicom AssureTouch 9970-SP6 Ref 9970-SP6

Class I FDA UDI Active
Hedy Dental Dam 310DB-6H Ref 310DB-6H

Class I FDA UDI Active
Amd-Ritmed All Gauze B3120 Ref B3120

Class I FDA UDI Active
Amd-Ritmed All Gauze 6008 Ref 6008

Class I FDA UDI Active
Ocean Pacific OPXS-BL2 Ref OPXS-BL2

Class I FDA UDI Active
Generic 561218 Ref 561218

Class II FDA UDI Active
Amd-Ritmed Solon Purfybr 4002D Ref 4002D

Class I FDA UDI Active
Medicom Safetouch 1266TG Ref 1266TG

Class I FDA UDI
Medicom Safebasics 8019 Ref 8019

Class I FDA UDI Active
Medicom Safebasics 8004 Ref 8004

Class I FDA UDI Active
Medicom Safemask Tailormade 2070 Ref 2070

Class II FDA UDI Active
Medicom Safetouch 1266mg Ref 1266MG

Class I FDA UDI
Steril Peel 221434RXEU Ref 221434RXEU

Class II FDA UDI Active
AMD Ritmed AssureWear VersaGown Ref K190306

Class II FDA 510(k) Active
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) Ref K190308

Class II FDA 510(k) Active

Showing 1,551-1,565 of 1,565

FDA recalls7

Device pages show only the recalls that name the device or its 510(k)/PMA.

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

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.

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 2026-05-08. 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.

Which FDA establishments are linked to AMD Medicom Inc?

1 FDA establishment is linked to AMD Medicom Inc in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.

Information

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

Catalogue1,565

Medicom AssureTouch 9970-SP6 Ref 9970-SP6

Hedy Dental Dam 310DB-6H Ref 310DB-6H

Amd-Ritmed All Gauze B3120 Ref B3120

Amd-Ritmed All Gauze 6008 Ref 6008

Ocean Pacific OPXS-BL2 Ref OPXS-BL2

Generic 561218 Ref 561218

Amd-Ritmed Solon Purfybr 4002D Ref 4002D

Medicom Safetouch 1266TG Ref 1266TG

Medicom Safebasics 8019 Ref 8019

Medicom Safebasics 8004 Ref 8004

Medicom Safemask Tailormade 2070 Ref 2070

Medicom Safetouch 1266mg Ref 1266MG

Steril Peel 221434RXEU Ref 221434RXEU

AMD Ritmed AssureWear VersaGown Ref K190306

FDA recalls7

FDA establishments1

What AMD Medicom Inc makes

Frequently asked questions

Information