Product code FMP— General Hospital

FDA has cleared 23 devices under product code FMP between 1976 and 2015, filed by 21 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20151 clearance
• 19951 clearance
• 19941 clearance
• 19821 clearance
• 19813 clearances
• 19803 clearances
• 19793 clearances
• 19783 clearances
• 19776 clearances
• 19761 clearance

• Fred Sammons, Inc.2 clearances
• Fibre Formations, Inc.2 clearances
• Tecnol New Jersey Wound Care, Inc.1 clearance
• Stock Wild & Co.1 clearance
• Stat Medical Corp.1 clearance
• Spenco Medical Corp.1 clearance
• Scanlan Intl., Inc.1 clearance
• Richard Hamer Assoc., Inc.1 clearance
• Omnicon Medical Corp.1 clearance
• Medsurg Industries, Inc.1 clearance

• K150243 — Invictus Medical GelShieldInvictus Medical, Inc.·2015-05-01
• K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSINGRichard Hamer Assoc., Inc.·1995-07-31
• K934731 — MEDSURG STERILE IMAGING PRODUCTSMedsurg Industries, Inc.·1994-03-28
• K820584 — DECUBICARE PADS & ACCESSORIESAbco Dealers, Inc.·1982-03-25
• K812344 — HEEL OR ELBOW PROTECTORFred Sammons, Inc.·1981-09-11
• K811184 — SPENCO DERMAL PADSSpenco Medical Corp.·1981-05-20
• K802829 — SCANLAN VASCU-STATTScanlan Intl., Inc.·1981-01-15
• K802185 — ARTERIAL BLOOD SAMPLING KITCurrent Technologies, Inc.·1980-10-10
• K801694 — FLOTATION PAD FOR OPERATING TABLEAction Products, Inc.·1980-08-27
• K801195 — DERMALEX OR NATRAWOOL SKIN PRESSURE PROTStock Wild & Co.·1980-06-09
• K792297 — SPAN AIDS KITAmerican Hospital Supply Corp.·1979-12-20
• K791709 — HEEL/ELBOW PROTECTORSFibre Formations, Inc.·1979-09-24
• K790995 — CONTEXFoam Tek, Inc.·1979-06-11
• K781246 — FOAM COMFORT RINGSFibre Formations, Inc.·1978-08-10
• K780171 — ELBOW PROTECTORStat Medical Corp.·1978-02-06
• K772419 — HEEL OR ELBOW PROTECTORFred Sammons, Inc.·1978-01-26
• K772060 — PROTECT IV GARDOmnicon Medical Corp.·1977-12-20
• K771913 — HEEL/ELBOW PROTECTORAlba-Waldensian, Inc.·1977-11-15
• K771633 — HEEL PROTECTORMedical Restraints, Inc.·1977-09-12
• K771519 — SPECIALIST ARM & LEG PROTECTORJohnson & Johnson Professionals, Inc.·1977-08-26
• K770635 — PROTECTOR, HEEL & ELBOWTecnol New Jersey Wound Care, Inc.·1977-05-23
• K761268 — SKIN PRESSURE PROTECTORSMark One Healthcare Products·1977-02-16
• K760870 — HEEL/ELBOW FLOTATION CUSHIONMedpro, Inc.·1976-11-01