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Protector, Skin Pressure

FDA product code FMP · Class 1 · General Hospital

0
Registered devices
239
Adverse events
4
Recalls
23
510(k) clearances

Devices with this code

Action® — ACTION PRODUCTS, INC.LapiLock — FUSION ORTHOPEDICS, LLCPILLOW ALIMED BARIATRIC FOOT PILLOW — ALIMED, INC.WAFFLE — EHOB INCMölnlycke®Z-Flo™ Fluidized Positioner — Mölnlycke Health Care ABDARCO® PegAssist™ Insole — DARCO INTERNATIONAL, INC.PRIMO — Asp Global, LLCWILSON FRAME PAD, 29 X 10 X 1 (SET OF 2) — MIZUHO ORTHOPEDIC SYSTEMS, INC."Silopad UGS Covered, Large/Xlarge, Left, 1pc/polybag " — Silipos Holding LLC"Silopad UGS Covered, Small/Medium, Left, 1pc/polybag " — Silipos Holding LLCMölnlycke®Z-Flo™ Fluidized Positioner — Mölnlycke Health Care ABPRIMO — Asp Global, LLCPRIMO — Asp Global, LLCAction® — ACTION PRODUCTS, INC.Bioseal Inc. — BIOSEALAction® — ACTION PRODUCTS, INC.SpandaNette — MEDI-TECH INTERNATIONAL CORPORATIONPAD, LATERAL, BOARD, 2" — MIZUHO ORTHOPEDIC SYSTEMS, INC.Guardian Mid-Calf Heel Protector — PRIMO INCALLEN — HILL-ROM, INC.PRIMO — Asp Global, LLCBlue Diamond — David Scott CompanySpandaNette — MEDI-TECH INTERNATIONAL CORPORATIONCS Pad 3” — CARE SURGICAL LIMITED

Recent recalls

DateFirmReason
2020-06-09EHOB, Inc.QC inspection observed that a portion of the lot may have been contaminated with blood.
2015-12-013M Company - Health Care BusinessProduct 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
2014-10-10Philips Medical Systems, Inc.Mold on gel filled Gel-E and Squishon products
2014-05-28Childrens Medical VenturesThe 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.