ClearanceBrief
Panels › General Hospital › Product code FNM · Class 2

Mattress, Air Flotation, Alternating Pressure

Regulation 880.5550

0510(k)s in 12 months (102 all time)
2recalls in 12 months (13 all time)
0recalls that name a 510(k)
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Top companies in FNM

Company510(k)sRecalls
Kinetic Concepts, Inc.80
Span-America Medical Systems, Inc.80
Huntleigh Technology, Inc.50
Hill-Rom Manufacturing, Inc.04
9th Wave, Inc.30
Gaymar Industries, Inc.30
Lumex, Inc.30
Pegasus Airwave, Inc.30
Plexus Medical30
Bio Clinic Co.20
Decided510(k)Device and applicantCode
Dec 23, 1994K943097CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM
Global Medical Technologies, Inc.
FNM
Dec 12, 1994K943353PLEXUS/1000
Plexus Medical
FNM
Sep 19, 1994K942920MEDAIR EXCEL 2000
Medifloat, Inc.
FNM
Jun 17, 1994K935949STRYKER 5000
Stryker Medical
FNM
Jun 17, 1994K934817SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS
Surgical Design Corp.
FNM
Mar 17, 1994K933965APEX MEDICAL AIR PUMPS
Apex Medical, Inc.
FNM
Mar 15, 1994K933402TURBO II
Kinetic Concepts, Inc.
FNM
Mar 7, 1994K933004PEGASUS BIWAVE SYSTEM
Pegasus Airwave, Inc.
FNM
Dec 21, 1993K933091STAGE IV, CM-4000,MATTRESS OVERLAY SYSTEM
Creative Medical, Inc.
FNM
Nov 12, 1993K932681PRESSUREGUARD IV
Span-America Medical Systems, Inc.
FNM
Aug 2, 1993K930673PREMIUM
Kinetic Concepts, Inc.
FNM
Jul 30, 1993K926403PRO-2000 LOW AIR LOSS THERAPY BED
Ch Administration, Inc.
FNM
Jul 27, 1993K926045SKYTRON LIFE ISLAND 21
Skytron, Div. the Kmw Group, Inc.
FNM
Jul 27, 1993K925651LIFE ISLAND 21
Keisei (Usa) Co., Ltd.
FNM
Jun 17, 1993K924005SANKEN MAT
Shima American Corp.
FNM
Jan 27, 1993K915306THE KAUFMANN LIFT-AND-TURN MATTRESS
Kaufmann Sjukvardsartiklar
FNM
Aug 11, 1992K922205BIO THERAPY PLUS
Sunrise Medical, Inc.
FNM
Apr 10, 1992K914775TALLEY MICRO SYSTEM/TALLEY RIPPLEBED
Talley Group, Ltd.
FNM
Jan 31, 1992K915061PROACT CLA-1500 SYSTEM
Clinical Systems, Inc.
FNM
Jan 10, 1992K913933TURNSOFT MATTRESS
Turnsoft, Inc.
FNM
Oct 3, 1990K901901PROFILE, A CRITICAL CARE LOW AIR LOSS BED
Kinetic Concepts, Inc.
FNM
Aug 21, 1990K901096LUMISCOPE ALTERNATING PRESSURE PAD & PUMP
Lumiscope Co., Inc.
FNM
Apr 4, 1990K900871ALTERNATING PRESSURE PUMP AND PAD SYSTEM
Three Bears Intl.
FNM
Feb 16, 1990K900131BIO FLOTE(R)
Bio Clinic Co.
FNM
Nov 17, 1989K891259MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD
Diamond Medical Equipment, Inc.
FNM
Jun 20, 1989K891457DR. VOLKNER'S LAMELLAR TURNING BED(TM)
James Consolidated, Inc.
FNM
Mar 29, 1989K890012HUNTLEIGH DYNAMIC FLOTATION SYSTEM
Huntleigh Technology, Inc.
FNM
Oct 31, 1988K883256BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM
Bio Clinic Co.
FNM
Aug 10, 1988K882644HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
Huntleigh Technology, Inc.
FNM
Jul 13, 1988K882092CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM
Gaymar Industries, Inc.
FNM
Jul 12, 1988K882161ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM
Ssi Medical Services, Inc.
FNM
Feb 22, 1988K874877PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER
Pegasus Airwave, Inc., GB
FNM
Feb 5, 1988K874801ORTHODERM THERAPY BED
Health Products, Inc.
FNM
Oct 9, 1987K871705LOW AIR LOSS BED
Integrated Medical Equipment Co.
FNM
Sep 4, 1987K872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
American Pharmaseal Div. Ahsc
FNM
Mar 4, 1987K870681HUNTLEIGH BETA II HM85
Huntleigh Technology, Inc.
FNM
Sep 23, 1986K863152MEDSENTRY FLOTATION SYSTEM
Medsentry Corp.
FNM
May 21, 1985K850419AUTO TURNER
George J. Kamilar
FNM
Jan 30, 1985K844499MEDSENTRY SOFTOUCH SYSTEM
Medsentry Corp.
FNM
Jan 25, 1985K844880HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES
Huntleigh Technology, Inc.
FNM
Jan 25, 1985K844879HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP
Huntleigh Technology, Inc.
FNM
Jan 30, 1984K833964PEGASUS MATTRESS
Dermalex Co.
FNM
Dec 31, 1981K813407AIR MATTRESS
Trans World Agency, Inc.
FNM
Jul 2, 1981K811684AMERICAN AIRCARE SYSTEM
American Hamilton
FNM
Jan 13, 1981K803307MATTRESS, AIR FLOATATION, ALTERN. PRESS.
Intl. Medical Equipment Corp.
FNM
Feb 26, 1980K800231ABCO/GRANT ALTERNATING PRESSURE PAD & UT
Abco Dealers, Inc.
FNM
Oct 26, 1979K792001COMFICARE PAD (FOR SINGEL PT USE)
Hamilton Industries, Inc.
FNM
Sep 7, 1978K781404BED PADS: D-12 AND D-8
Grant Airmass Corp.
FNM
Aug 10, 1978K780906AIR-FLO ALTERNATING PRESSURE PAD SYSTEM
Gaymar Industries, Inc.
FNM
Apr 10, 1978K780502NOVA AIR FLOATATION SYSTEM
Nova Health Systems, Inc.
FNM

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