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Gown, Examination
FDA product code FME · Class 1 · General Hospital
590
Registered devices
15
Adverse events
1
Recalls
5
510(k) clearances
Devices with this code
Encompass — Encompass Group, L.L.C.Exam Capes, Tissue/Poly/Tissue 3-ply, Lavender, Universal — Dynarex CorporationPRO ADVANTAGE — NATIONAL DISTRIBUTION & CONTRACTING, INC.Thermoflect — Encompass Group, L.L.C.Defend — YOUNG MYDENT, LLCEncompass — Encompass Group, L.L.C.JMU — JMU DENTAL, INCTronex International, Inc. — TRONEX INTERNATIONAL, INC.ICP — ICP MEDICAL, LLCEncompass — Encompass Group, L.L.C.MediChoice — OWENS & MINOR DISTRIBUTION, INC.Tronex International, Inc. — TRONEX INTERNATIONAL, INC.MAMMOGRAM ROBE — STANDARD TEXTILE CO., INC.ThermalX — ADROIT MEDICAL SYSTEMS, INC.Encompass — Encompass Group, L.L.C.Halyard — O&M HALYARD, INC.ThermalX — ADROIT MEDICAL SYSTEMS, INC.JMU — JMU DENTAL, INCDefend — YOUNG MYDENT, LLCPRIMED — priMED Medical Products IncVIVIT Supply — Vivit Supply LLCExam Gowns, Tissue/Poly/Tissue 3-ply, White, Universal — Dynarex CorporationDefend — YOUNG MYDENT, LLCDefend — YOUNG MYDENT, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-12-23 | Encompass Group LLC | The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment. |
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