Home › Device types › KME
Bedding, Disposable, Medical
FDA product code KME · Class 1 · General Hospital
806
Registered devices
64
Adverse events
2
Recalls
65
510(k) clearances
Devices with this code
Thermoflect — Encompass Group, L.L.C.DriPad — Merit Medical Systems, Inc.Sage AirTAP LC — SAGE PRODUCTS, LLCPremierPro — PRESTIGE AMERITECH, LTD.Simplicity — Cardinal Health, Inc.Action® — ACTION PRODUCTS, INC.Thermoflect — Encompass Group, L.L.C.Henry Schein — HENRY SCHEIN, INC.MedSource Pillow Case — MEDSOURCE INTERNATIONAL LLCPKIT, SLEEVE, PAD COVER — MIZUHO ORTHOPEDIC SYSTEMS, INC.PRIMO — Asp Global, LLCSURGYCO — Surgyco LLCPremierPro — PRESTIGE AMERITECH, LTD.Halyard — O&M HALYARD, INC.Ready-Heat — TECHTRADE, LLCCS Jackson Covers Hip & Thigh Combo Set — CARE SURGICAL LIMITEDAmerisourceBergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANYVYGON — VYGONDisposable Blue Non-Woven Blanket — Dynarex CorporationPolycoated Headrest covers — CROSSTEX INTERNATIONAL, INC.MEDLINE — MEDLINE INDUSTRIES, INC.Drape Sheets — Dynarex CorporationCEGA Innovations, Inc. — Cega Innovations, Inc.Alleset — GRI Medical & Electronic Technology Co., Ltd.
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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