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Gown, Examination
FDA product code FME · Class 1 · General Hospital
580
Registered devices
7
Adverse events
1
Recalls
5
510(k) clearances
Devices with this code
MAMMOGRAM JACKET — STANDARD TEXTILE CO., INC.MAMMOGRAM JACKET — STANDARD TEXTILE CO., INC.Patientstyle — PATIENTSTYLE MEDICAL LLCEncompass — Encompass Group, L.L.C.MARK3 — CARGUS INTERNATIONAL, INCMARK3 — CARGUS INTERNATIONAL, INCJMU — JMU DENTAL, INCDefend — YOUNG MYDENT, LLCEncompass — Encompass Group, L.L.C.Defend — YOUNG MYDENT, LLCTronex International, Inc. — TRONEX INTERNATIONAL, INC.Drape Sheets — Dynarex CorporationPRIMED — priMED Medical Products IncMAMMOGRAM ROBE — STANDARD TEXTILE CO., INC.ThermalX — ADROIT MEDICAL SYSTEMS, INC.MAMMOGRAM CAPE — STANDARD TEXTILE CO., INC.Defend — YOUNG MYDENT, LLCEncompass — Encompass Group, L.L.C.Encompass — Encompass Group, L.L.C.McKesson — MCKESSON MEDICAL-SURGICAL INC.JMU — JMU DENTAL, INCProtexter — ICP MEDICAL, LLCTronex International, Inc. — TRONEX INTERNATIONAL, INC.SURGYCO — Surgyco 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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