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Bedding, Disposable, Medical
FDA product code KME · Class 1 · General Hospital
829
Registered devices
94
Adverse events
2
Recalls
65
510(k) clearances
Devices with this code
Invenio — GRI Medical & Electronic Technology Co., Ltd.CS Jackson Comfort Covers - 5 Piece — CARE SURGICAL LIMITEDThermoflect — Encompass Group, L.L.C.AMD-RITMED — AMD Medicom IncEMSRUN — Wuxi Emsrun Technology Co., Ltd.Action® — ACTION PRODUCTS, INC.Alleset — GRI Medical & Electronic Technology Co., Ltd.Thermoflect — Encompass Group, L.L.C.Curaplex — BOUND TREE MEDICAL, LLCBioseal Inc. — BIOSEALAllCare, INC — ALLCARE, INCSure Care — Cardinal Health, Inc.Henry Schein — HENRY SCHEIN, INC.Premium Flat Cot Sheet — Dynarex CorporationPremium Flat Cot Sheet — Dynarex CorporationExam Gowns, Tissue/Poly/Tissue 3-ply, White, Universal — Dynarex CorporationBioseal Inc. — BIOSEALMedSource Blanket — MEDSOURCE INTERNATIONAL LLCHALYARD — GRI Medical & Electronic Technology Co., Ltd.PremierPro — PRESTIGE AMERITECH, LTD.MEDLINE — MEDLINE INDUSTRIES, INC.Pinestar Technology Inc — PINESTAR TECHNOLOGY, INC.SURGYCO — Surgyco LLCEncompass — Encompass Group, L.L.C.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-06-23 | Microtek Medical Inc. | Certain lots of the products have a Naphthalene odor. |
| 2017-12-27 | LITTLE RAPIDS CORPORATION | The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. The product is design |
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