Home › Device types › FMP
Protector, Skin Pressure
FDA product code FMP · Class 1 · General Hospital
2,561
Registered devices
232
Adverse events
4
Recalls
23
510(k) clearances
Devices with this code
SofCare — STRYKER CORPORATIONFOOTHOLD — EHOB INCPRIMO — Asp Global, LLC5904 Bandage Kit — SIGVARIS INCDigital Pads On A Strip, Mini, Antibac, 2strips/bag (17 pads/strip) — Silipos Holding LLCGel Toe Spreader, Large, Bulk, 100pcs/bag — Silipos Holding LLCDeRoyal — DEROYAL INDUSTRIES, INC.DARCO® Toe Cap — Darco (Europe) GmbHPRIMOBoot, Fall Risk - Small — PRIMO INCIMP Pad Square — Innovative Medical Products, IncBioseal Inc. — BIOSEALALLEN — HILL-ROM, INC.DERMACARE — EHOB INCCarpal Sleeve with 2 Thumb Holes - Bulk — Silipos Holding LLCSilopad Digital Caps, Small/Medium, Pink, Bulk, 100/bag — Silipos Holding LLCCS Head Strap Disposable — CARE SURGICAL LIMITEDArthrex — ALLEN MEDICAL SYSTEMS, INC.DARCO® Body Armor® Toe Guard — DARCO INTERNATIONAL, INC.Action® — ACTION PRODUCTS, INC.Centurion — CENTURION MEDICAL PRODUCTS CORPORATIONDARCO® Toe Cap — Darco (Europe) GmbHPRIMO — Asp Global, LLCBlue Diamond — David Scott CompanyAction® — ACTION PRODUCTS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-06-09 | EHOB, Inc. | QC inspection observed that a portion of the lot may have been contaminated with blood. |
| 2015-12-01 | 3M Company - Health Care Business | Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allerg |
| 2014-10-10 | Philips Medical Systems, Inc. | Mold on gel filled Gel-E and Squishon products |
| 2014-05-28 | Childrens Medical Ventures | The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporiu |
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