Home › Device types › FYC
Gown, Isolation, Surgical
FDA product code FYC · Class 2 · General, Plastic Surgery
152
Registered devices
34
Adverse events
2
Recalls
68
510(k) clearances
Devices with this code
Medline — MEDLINE INDUSTRIES, INC.NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLCMediChoice — OWENS & MINOR DISTRIBUTION, INC.Copioumed — COPIOUMED INTERNATIONAL INC.Copioumed — COPIOUMED INTERNATIONAL INC.CALICO — Calico Medical Group LLCCARDINAL HEALTH — Cardinal Health 200, LLCBusse Hospital Disposables — ROBERT BUSSE & CO., INC.Copioumed — Copious International Inc.PRIMED — priMED Medical Products IncPRIMED — priMED Medical Products IncPRIMED — priMED Medical Products IncCopioumed — COPIOUMED INTERNATIONAL INC.Halyard — O&M HALYARD, INC.MediChoice — OWENS & MINOR DISTRIBUTION, INC.PRIMED — priMED Medical Products IncProtexer — ICP MEDICAL, LLCHalyard — O&M HALYARD, INC.Busse Hospital Disposables — ROBERT BUSSE & CO., INC.Resilient Medical Solutions — Resilient Medical Solutions, LLCMediChoice — OWENS & MINOR DISTRIBUTION, INC.CALICO — Calico Medical Group LLCAlleset — GRI Medical & Electronic Technology Co., Ltd.Copioumed — COPIOUMED INTERNATIONAL INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-01 | Cardinal Health 200, LLC | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Associat |
| 2024-11-01 | Cardinal Health 200, LLC | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Associat |
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