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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
OVATION AGC-2 (K963818)Orsonique, Inc.1996-10-28
PROSYS SAMEC LA (K963265)Convatec, A Division of E.R. Squibb & Sons1996-10-25
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING (K963096)Smith & Nephew United, Inc.1996-10-25
IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM (K963395)Sectra-Imtec AB1996-10-25
VIEWSEND MEDICAL MODEL 1200 (K962225)Klt Telecom, Inc.1996-10-25
RAPID ELECTROPHORESIS ANALYZER (K960571)Helena Laboratories1996-10-25
PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED) (K963514)Shanghai PM Plastics Enterise Co., Ltd.1996-10-24
CHECKMATE ANKLE RESTRAINT SYSTEM (K962963)Hollister, Inc.1996-10-24
PROSTYLE COMPACT (K963209)Planmeca Oy1996-10-24
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE (K963560)Pwa Industries Sdn. Bhd.1996-10-24
PACER PLUS SYNTHETIC MEDICAL VINYL PATIENT EXAMINATION GLOVE POWDER FREE (K963710)Canopus Medical Supply Co., Ltd.1996-10-24
DENTAL HANDPIECE AND ACCESSORY (K963664)Filmtech, Inc.1996-10-24
HEELBO JOHNNY GRAIT BELT SECURITY BELT (K962964)Hollister, Inc.1996-10-24
STANDARD WHEELCHAIR (K963301)L & M Resource Information Service, Inc.1996-10-23
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL (K963213)Boehringer Mannheim Corp.1996-10-23
STAPLE REMOVAL KIT (K963234)Continental Medical Laboratories, Inc.1996-10-21
WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH (K963569)Medline Industries, Inc.1996-10-18
HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP (K962832)Heelbo, Inc.1996-10-18
MEDLINE PELVIC HOLDER (K963404)Medline Industries, Inc.1996-10-18
C.O.L.D.A. (K963630)C.O.L.D.A. S.N.C.1996-10-18
RAND NASAL PACKING (K963856)Rand Scientific Corp.1996-10-18
VITROS IMMUNODIAGNOSTIC SYSTEM (K962919)Johnson & Johnson Clinical Diagnostics, Inc.1996-10-18
PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS (K963458)Skil-Care Corp.1996-10-18
MEDLINE BODY HOLDER (K963360)Medline Industries, Inc.1996-10-18
MEDLINE ZIPPER SLEEVED VEST (K963452)Medline1996-10-18
MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT (K963362)Medline Industries, Inc.1996-10-18
MIDWEST 300 SE (K962877)Midwest Dental Products Corp.1996-10-18
LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46) (K963353)Reckitt Benckiser, Inc.1996-10-18
THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE (K962831)Heelbo, Inc.1996-10-18
HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP (K962834)Heelbo, Inc.1996-10-18
HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP (K962839)Heelbo, Inc.1996-10-18
HANS RUDOLPH NASAL CPAP MASK (K962848)Hans Rudolph, Inc.1996-10-16
STRAIT JACKET (K963463)Deroyal Industries, Inc.1996-10-16
CIBA CORNING ACS;180 DPD ASSAY (K963251)Ciba Corning Diagnostics Corp.1996-10-15
SUPPORT VEST (K963459)Skil-Care Corp.1996-10-15
COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED) (K953213)Wembley Rubber Products (M) Sdn Bhd1996-10-11
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES (K954416)Hartalega Sdn Bhd1996-10-11
REIGEL TUNNELING DEVICE (K962761)Cook, Inc.1996-10-11
MULTI-PURPOSE MEDICAL TUBE HOLDER (K963365)Byrd Medical Devices, Inc.1996-10-11
HEELBO WRAP AROUND VEST (K963294)Heelbo, Inc.1996-10-11
TRADITION P, PUSH BUTTON HANDPIECE (K963050)Midwest Dental Products Corp.1996-10-11
OSOM STREP A TEST (K961423)Wyntek Diagnostics, Inc.1996-10-11
SAFETY PONCHO/SHOULDER STRAP PONCHO (K963461)Skil-Care Corp.1996-10-11
TEMPRA COLD PACK, REORDER NO. TC150 (K963220)Tempo Technology, Inc.1996-10-10
ROLL BELT (K963460)Skil-Care Corp.1996-10-09
SLEEPER JACKET/HOUDINI SAFETY SLEEPER (K963457)Skil-Care Corp.1996-10-09
HEELBO ICU 911 BLAZER SLEEVED JACKET (K963237)Heelbo, Inc.1996-10-09
THE L-BOW ARM RESTRAINT (K962778)Heelbo, Inc.1996-10-09
GREAT HANDS MITTS (K962810)Heelbo, Inc.1996-10-09
HEELBO QUILTED TORSO RESTRAINT (K963108)Hollister, Inc.1996-10-09
OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE (K962941)Deep Trading Corp.1996-10-08
SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL (K963455)Skil-Care Corp.1996-10-08
IDS RAPID CB PLUS SYSTEM (K962966)Innovative Diagnostic Systems, Inc.1996-10-08
LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER (K963456)Skil-Care Corp.1996-10-08
VIDAS CHLAMYDIA BLOCKING ASSAY (K955627)Biomerieux Vitek, Inc.1996-10-07
BIO-CSF LIQUID CONTROL LEVEL 1 AND 2 (K963551)Biocell Laboratories, Inc.1996-10-07
LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION) (K961415)Siam Sempermed Corp., Ltd.1996-10-07
PELVIC HOLDER (K963449)Skil-Care Corp.1996-10-07
SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST (K963450)Skil-Care Corp.1996-10-07
ECONO BELT (K963448)Skil-Care Corp.1996-10-07
EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT (K962146)Excel Scientific, Inc.1996-10-07
LATEX PATIENT EXAMINATION GLOVE (PINK) (K961602)Siam Sempermed Corp., Ltd.1996-10-07
DOUBLE SUPPORT PONCHO/SLIDER PONCHO (K963447)Skil-Care Corp.1996-10-07
T.B.Q. (K962739)Convatec, A Division of E.R. Squibb & Sons1996-10-07
CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT (K963454)Skil-Care Corp.1996-10-07
PATIENT PROTECTIVE LIMB (K962626)Kenad SG Medical, Inc.1996-10-02
ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) (K962745)Prepared Media Laboratory, Inc.1996-10-02
NULIFE (K962837)Med-Tech Rubber & Engineering Industries1996-10-02
INTRA-ORAL THERMOPLASTIC SHIELD (K962622)Medtec, Inc.1996-10-01
HEELBO BLAZER SLEEVED JACKET (K963243)Heelbo, Inc.1996-10-01
ORLAU SWIVEL WALKER (K923880)Mopac, Ltd.1996-09-30
DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION (K963604)Midwest City Hearing Aid Center1996-09-27
EUROLINE A-675 SERIS (K963519)Starkey Laboratories, Inc.1996-09-27
TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K963080)Bayer Corp.1996-09-27
DCA 2000 + MICROALBUMIN/CREATININE ASSAY (K963142)Bayer Corp.1996-09-27
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) (K962890)Trace Scientific , Ltd.1996-09-27
ANKLE CALF EXERCISER PHLEBOPUMP (K952975)Prevent Products, Inc.1996-09-25
S-53 INTRORAL DENTAL SYSTEM (K962979)Del Medical Systems Corp.1996-09-25
AIR MOTOR HANDPIECE TN-102 (K962542)Nsk Nakanishi, Inc.1996-09-24
QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 (K961544)Consolidated Technologies, Inc.1996-09-24
PROD NO. 01-1694 - 4X4 FOAM DRESSING (K954728)Continental Medical Laboratories, Inc.1996-09-23
MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES (K962986)Johnson & Johnson Medical, Inc.1996-09-20
HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL (K963607)Midwest City Hearing Aid Center1996-09-20
SCION SAPHENOUS VEIN HARVESTING SYSTEM (K963006)Scion International, Inc.1996-09-20
SAFETY VEST (K962429)Johnson & Johnson Professionals, Inc.1996-09-18
10B ARGININE BROTH (K961046)Remel, L.P.1996-09-18
GONOPOX TEST KIT (K960759)Medtex Laboratories, Inc.1996-09-18
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (K962843)Starplex Scientific, Inc.1996-09-18
LATEX PATIENT EXAMINATION GLOVE (K960942)Siam Sempermed Corp., Ltd.1996-09-17
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT (K952220)Meretek Diagnostics, Inc.1996-09-17
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 (K961941)Bio-Rad1996-09-16
IN THE EAR HEARING AID (K962388)Unique Hearing Technology, Inc.1996-09-16
SELF RETAINING MALE EXTERNAL URINARY CATHETER (K962900)Hollister, Inc.1996-09-16
CLEARVIEW C. DIFF A (K955067)Unipath , Ltd.1996-09-13
LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2 (K961359)Bioprocessing, Inc.1996-09-13
NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES (K962319)Neoprobe Corp.1996-09-13
E-TYPE CONTRA ANGLE NAC-E (K962540)Nsk Nakanishi, Inc.1996-09-12
DMS-9000 (K960836)O.R. Solutions, Inc.1996-09-12
ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU (K962543)Nsk Nakanishi, Inc.1996-09-11
BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) (K962425)Radi Medical Systems AB1996-09-11
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