Data / Medical devices / Canada / AMD Medicom Inc.
AMD Medicom Inc.: FDA-registered device maker in Pointe-Claire, Montreal Quebec, Canada, 43 510(k) clearances
AMD Medicom Inc. is registered with the FDA (registration 9611959) in Pointe-Claire, Montreal Quebec, Canada. It lists 53 device types. The FDA files 43 510(k) clearances under its listings, the newest dated May 28, 2025. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9611959
- FEI number
- 3002677549
- Address
- 2555 Chemin de l'Aviation, Pointe-Claire, Montreal Quebec, Canada, H9P 2Z2
- Owner or operator
- AMD Medicom Inc (8020405)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Repackager or relabeler, Specification developer
- First device listed
- October 23, 2000
- Registered through
- 2027
- Brand names listed
- AMD-Ritmed Abdominal Pads;, AMD-Ritmed Adhesive Fabric Bandage, AMD-Ritmed Adhesive Plastic Bandage, AMD-Ritmed Adhesive Tape, AMD-Ritmed Boot Covers, AMD-Ritmed Bouffant Caps, AMD-Ritmed Cohesive Bandage, AMD-Ritmed Cotton Roll and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Accessory, Surgical Apparel | LYU | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Complaint file establishment | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Exporter to the US | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Chair, Dental, Without Operative Unit | NRU | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Counter, Sponge, Surgical | LWH | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Gauze/Sponge, Internal | EFQ | U | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Complaint file establishment, Exporter to the US, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Indicator, Biological Sterilization Process | FRC | 2 | Complaint file establishment, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Complaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Complaint file establishment, Exporter to the US, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Complaint file establishment, Exporter to the US | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Oral Wound Dressing | OLR | U | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Pediatric/Child Facemask | OXZ | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Powder-Free Polychloroprene Patient Examination Glove | OPC | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Retainer, Matrix | JEP | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Exporter to the US | accessdata.fda.gov |
| Shaker/Stirrer | JRQ | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Tray, Fluoride, Disposable | KMT | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Unit, Syringe, Air And/Or Water | ECB | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Utensil, Eating | ILC | 1 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Complaint file establishment, Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Complaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 28, 2025 | K240950 | Disposable Prophy Angle | EGS | Substantially Equivalent | Pacific Care Limited | accessdata.fda.gov |
| June 21, 2024 | K240862 | Medicom Sterilization Wrap | FRG | Substantially Equivalent | Medicom Group, Inc. | accessdata.fda.gov |
| May 28, 2024 | K240629 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | Xingyu Medical Tech Co., Ltd. | accessdata.fda.gov |
| March 24, 2023 | K230002 | Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Mah Sing Healthcare Sdn. Bhd. | accessdata.fda.gov |
| January 26, 2023 | K223415 | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Mah Sing Healthcare Sdn. Bhd. | accessdata.fda.gov |
| November 20, 2022 | K221165 | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | Sri Trang Gloves (Thailand) Public Company Limited | accessdata.fda.gov |
| November 10, 2022 | K222551 | Humask Pro Vision, Humask Pro Vision 3000 | FXX | Substantially Equivalent | Entreprise Premont, Inc. | accessdata.fda.gov |
| January 11, 2022 | K212735 | Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) | LZA | Substantially Equivalent | Xingyu Medical Tech Co., Ltd. | accessdata.fda.gov |
| December 2, 2021 | K212578 | Nitrile disposable examination gloves | LZA | Substantially Equivalent | Xingyu Medical Tech Co., Ltd. | accessdata.fda.gov |
| August 11, 2021 | K202536 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| August 3, 2021 | K211758 | Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) | OPC | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| April 25, 2020 | K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| April 6, 2020 | K200019 | Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| January 17, 2020 | K190306 | AMD Ritmed AssureWear VersaGown | FYC | Substantially Equivalent | Amd Medicom, Inc. | accessdata.fda.gov |
| September 17, 2019 | K190308 | 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) | OXZ | Substantially Equivalent | Amd Medicom, Inc. | accessdata.fda.gov |
| September 13, 2019 | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye | FRC | Substantially Equivalent | Terragene S.A. | accessdata.fda.gov |
| March 19, 2019 | K182383 | Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue | LZC | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| October 3, 2018 | K182115 | Vinyl Patient Examination Gloves | LYZ | Substantially Equivalent | Pingan Medical Products Co., Ltd. | accessdata.fda.gov |
| February 22, 2018 | K171823 | U&U Indicator tape and strip | JOJ | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| January 24, 2018 | K173196 | SUNTOUCH Dental Dressing | OLR | Substantially Equivalent | Huizhou Foryou Medical Devices Co., Ltd. | accessdata.fda.gov |
| December 12, 2017 | K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| November 15, 2017 | K171873 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Zhonghong Pulin Medical Products Co., Ltd. | accessdata.fda.gov |
| February 6, 2017 | K162923 | NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| November 2, 2016 | K162095 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| May 20, 2016 | K153334 | Oral-B 5% Sodium Fluoride Varnish | LBH | Substantially Equivalent | Young Dental Manufacturing Co. 1, LLC | accessdata.fda.gov |
| December 3, 2014 | K141412 | STERILUCENT SELF-SEAL STERILIZATION POUCH | FRG | Substantially Equivalent | Gs Medical Packaging, Inc. | accessdata.fda.gov |
| September 22, 2014 | K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | LBH | Substantially Equivalent | Nanova Biomaterials, Inc. | accessdata.fda.gov |
| January 31, 2014 | K132221 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Shandong Haoyu Medical Products Co., Ltd. | accessdata.fda.gov |
| February 17, 2012 | K112654 | POWDERFREE POLYISOPRENE SURGICAL GLOVES | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| May 14, 2010 | K093794 | SMART-READ EZTEST-STEAM SCBI AND TEST PACK | FRC | Substantially Equivalent | Sgm Biotech, Inc. | accessdata.fda.gov |
| September 4, 2009 | K091652 | NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| December 27, 2007 | K071886 | SELF SEAL STERILIZATION POUCH | FRG | Substantially Equivalent | Shanghai Jianzhong Medical Packaging Co., Ltd. | accessdata.fda.gov |
| July 17, 2007 | K070428 | MEDICOM SELF-SEALING STERILIZATION POUCH | KCT | Substantially Equivalent | A.R. Medicom, Inc. | accessdata.fda.gov |
| September 20, 2005 | K051291 | NON-STERILE SURGICAL MASK | FXX | Substantially Equivalent | A.R. Medicom, Inc. | accessdata.fda.gov |
| April 22, 2004 | K040607 | MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| February 4, 2004 | K040098 | VARNISHAMERICA | LBH | Substantially Equivalent | Medical Products Laboratories, Inc. | accessdata.fda.gov |
| April 14, 2003 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | EGS | Substantially Equivalent | Pac-Dent International (Suzhou), Ltd. | accessdata.fda.gov |
| March 14, 2003 | K030228 | POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES | KGO | Substantially Equivalent | Pt. Medisafe Technologies | accessdata.fda.gov |
| July 23, 2002 | K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | MSH | Substantially Equivalent | Makrite Industries, Inc. | accessdata.fda.gov |
| November 9, 1995 | K953829 | SAFE-T-SEAL | KCT | Substantially Equivalent | Gs Medical Packaging, Inc. | accessdata.fda.gov |
| December 16, 1993 | K931202 | STERILIZATION WRAP-STERISHEET | FRG | Substantially Equivalent | Arjo Wiggins Medical, Inc. | accessdata.fda.gov |
| November 3, 1989 | K895077 | SURGICAL MASK/DENTAL MASK | FXX | Substantially Equivalent | Ashton Medical Products, Inc. | accessdata.fda.gov |
| June 2, 1983 | K830269 | FLORET NEURO SPONGE | EFQ | Substantially Equivalent | Ritmed, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 8, 2026 | 99006 | Class II | Ongoing | Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-St | 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 | accessdata.fda.gov |
| December 21, 2023 | 93818 | Class II | Ongoing | HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code ) | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. | accessdata.fda.gov |
| October 11, 2019 | 84118 | Class II | Terminated | MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040 | 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. | accessdata.fda.gov |
Compare with other makers
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- All makers of Mask, Surgical
- All makers of Dressing, Compression
Updated June 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.