AMD Medicom Inc.
Lockbourne, OH, US
AMD Medicom Inc. appears in FDA device records in Lockbourne, OH. FDA records list 2 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for AMD Medicom Inc. between 2019 and 2020. The busiest year on record is 2019, with 1. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190306 | AMD Ritmed AssureWear VersaGown | FYC | Substantially Equivalent | |
| 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 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017425988 | 3017425988 | AMD MEDICOM INC. | 400 , Rue Stinson, Saint-Laurent Quebec H4N 2E9 CA | 2026 | |
| 3012482820 | 3012482820 | AMD Medicom Inc. | 6054 Shook Road, Lockbourne, OH 43137 US | 2026 | No device listings on this registration |
| 9611959 | 3002677549 | AMD Medicom Inc. | 2555 Chemin de l'Aviation, Pointe-Claire, Montreal Quebec H9P 2Z2 CA | 2026 | and 43 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHRAbsorber, Saliva, Paper
- LYUAccessory, Surgical Apparel
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KXFApplicator, Absorbent Tipped, Non-Sterile
- KXGApplicator, Absorbent Tipped, Sterile
- FQMBandage, Elastic
- KMEBedding, Disposable, Medical
- GESBlade, Scalpel
- FYFCap, Surgical
- NRUChair, Dental, Without Operative Unit
- EFNCotton, Roll
- LWHCounter, Sponge, Surgical
- FMWCover, Mattress (Medical Purposes)
- FXPCover, Shoe, Operating-Room
- EIEDam, Rubber
- FMADepressor, Tongue, Non-Surgical
- MHWDressing, Compression
- NACDressing, Wound, Hydrophilic
- QDOFentanyl And Other Opioid Protection Glove
- FRLFiber, Medical, Absorbent
- NABGauze / Sponge,Nonresorbable For External Use
- EFQGauze/Sponge, Internal
- GDYGauze/Sponge, Internal, X-Ray Detectable
- FYCGown, Isolation, Surgical
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- FRCIndicator, Biological Sterilization Process
- JOJIndicator, Physical/Chemical Sterilization Process
- DZNInstruments, Dental Hand
- FXXMask, Surgical
- LZCMedical Glove, Specialty
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- DYNMouthpiece, Saliva Ejector
- OEANon-Surgical Gown
- OLROral Wound Dressing
- HMPPad, Eye
- OXZPediatric/Child Facemask
- LZAPolymer Patient Examination Glove
- OPCPowder-Free Polychloroprene Patient Examination Glove
- MSHRespirator, Surgical
- JEPRetainer, Matrix
- GDXScalpel, One-Piece
- JRQShaker/Stirrer
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- ILISling, Arm
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- KGOSurgeon'S Gloves
- KGXTape And Bandage, Adhesive
- KMTTray, Fluoride, Disposable
- ECBUnit, Syringe, Air And/Or Water
- ILCUtensil, Eating
- LBHVarnish, Cavity
- LYZVinyl Patient Examination Glove
- FRGWrap, Sterilization
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2459-2026 | Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C | 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. | Class II | Open, Classified | |
| Z-2458-2026 | 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-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C | 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. | Class II | Open, Classified | |
| Z-1148-2024 | PATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573) | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. | Class II | Open, Classified | |
| Z-1147-2024 | HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281) | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. | Class II | Open, Classified | |
| Z-1146-2024 | HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. | Class II | Open, Classified | |
| Z-0495-2020 | MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042 | 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. | Class II | Terminated | |
| Z-0494-2020 | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain