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

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RecordFirmDate
Z33 (K953050)Electone, Inc.1995-08-22
ACRYLIC DIPPED LATEX SURGICAL GLOVES - STERILE (K945505)Ganz Industries Sdn. Bhd.1995-08-18
TEC-2110 GREEN LASER MODEL MT-HNG (K950293)Medtec, Inc.1995-08-18
THE ASSISTANT (K952841)Apple Medical Corp.1995-08-18
ACRYLIC DIPPED LATEX EXAMINATION GLOVES - STERILE (K945504)Ganz Industries Sdn. Bhd.1995-08-18
CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS (K952180)Beckman Instruments, Inc.1995-08-17
TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM (K952741)Medical Diagnostic Technologies, Inc.1995-08-17
CENTRALITE(R)-DLL SERIES (K950112)Diacor, Inc.1995-08-16
Z35 (K953051)Electone, Inc.1995-08-15
REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION (K952396)Contour Fabricators of Florida, Inc.1995-08-15
ANESTHESIA/RESPIRATORY FACE MASK (K953107)Medical Marketing Concepts1995-08-15
PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR (K932333)Gull Laboratories, Inc.1995-08-15
WARM-SCALE (K952649)Olympic Medical Corp.1995-08-15
AM 260 K-AMP (K953052)Electone, Inc.1995-08-15
Z22 (K953048)Electone, Inc.1995-08-15
OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) (K952363)Ela Medical, Inc.1995-08-15
AM 260 OHM (K953054)Electone, Inc.1995-08-15
REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION (K952395)Contour Fabricators of Florida, Inc.1995-08-15
Z24 (K953049)Electone, Inc.1995-08-15
AM 260 PP (K953053)Electone, Inc.1995-08-15
ABBOTT TEST PACK STREP A TEST (K945571)Abbott Laboratories1995-08-14
COVERSAN, ISLESAN (K952547)Medical Device Development Co.1995-08-14
CUTINOVA CAVITY (K952526)Beiersdorf, Inc.1995-08-14
BODYFLEX MASSAGER (K952041)Truro'S Ent.1995-08-14
SUNGLASSES (K941084)Blue Gem Sunglasses, Inc.1995-08-14
MING-YA OPTICAL INDUSTRIALCO., LTD. (K951801)Min-Ya Optical Industrial Co., Ltd.1995-08-14
ROYAL SHIELD NON-STERILE PINK COLOERED, STRAWBERRY SCENTED LATEX EXAMINATION GLOVES (K952590)Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.1995-08-14
GLOVETEX (MULTIPLE) (K952197)Pt Mbf Buana Multicorpora1995-08-14
C-FLEX SEPTAL SPLINTS (K952226)Trebay Medical Corp.1995-08-11
FORMULATION HWS-64 EPA REG. NO. 47371-131 (K953011)Huntington Laboratories, Inc.1995-08-11
VRS 3 WALL STAND (K953336)Philips Medical Systems (Cleveland), Inc.1995-08-11
ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATION GLOVES (K952589)Shield Gloves Manufacturer (M) Sdn Bhd1995-08-11
SAFESKIN (K952793)Safeskin Corp.1995-08-11
ANESTHESIA FACE MASK (K953295)Mallinckrodt Medical1995-08-11
CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR (K951414)Champion Mfg. Corp.1995-08-11
BOSTON MEDICAL LATEX EXAM GLOVES (K952695)Shun Thai Rubber Gloves Industry Co., Ltd.1995-08-11
UNIVERSIX 190 (K953402)Philips Medical Systems (Cleveland), Inc.1995-08-11
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR (K951331)Boehringer Mannheim Corp.1995-08-11
FORMULATION HWS-256 EPA REG. NO. 47371-129 (K953010)Huntington Laboratories, Inc.1995-08-11
JEDMED SPECTRUM ENT CABINET (K953457)Jedmed Instrument Co.1995-08-11
FORMULATION HWS-128 EPA REG. NO. 47371-130 (K953009)Huntington Laboratories, Inc.1995-08-11
ROYAL SHIELD NON-STERILE BLUE COLORED BUBBLE GUM SCENTED LATEX EXAMINATION GLOVES (K952591)Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc.1995-08-11
NEEDLE SAFETY COVER (K950098)Hammer-Plane, Inc.1995-08-11
COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPM (K951771)Sms Technologies, Ltd.1995-08-11
SAFESKIN (K952851)Safeskin Corp.1995-08-11
SECURE-SITE (K941098)Op-Co Medical Products , Ltd.1995-08-09
UNSCENTED MENSTRUAL LINER (K953488)Paragon Trade Brands, Inc.1995-08-09
UNSCENTED MENSTRUAL SHIELD (K953487)Paragon Trade Brands, Inc.1995-08-09
RUSCH ENDOTRACHEAL TUBE STYLET (K952100)Rusch, Inc.1995-08-08
STRYKER COMMAND2 OFFICE CONSOLE (K953071)Stryker Instruments1995-08-08
PULM O2 SUCTION CATHETER TRAYS (K953226)Premium Plastics, Inc.1995-08-08
HENNERT SA (K952734)Hennert S.A.1995-08-08
SILON SILICONE TEXTILE COMPOSITE (K952546)Bio Med Sciences, Inc.1995-08-07
SPI-SECRET PERSONAL INSTRUMENT CIC (K952986)Midwest City Hearing Aid Center1995-08-07
MAGNESIUM REAGENT (K952426)Schiapparelli Biosystems, Inc.1995-08-07
SUNGLASSES (NON-PRESCRIPTION) (K953473)Cbi Dist.1995-08-07
ALANINE AMINOTRANSFERASE REAGENT SYSTEM (K952744)Medical Diagnostic Technologies, Inc.1995-08-07
REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION (K952406)Contour Fabricators of Florida, Inc.1995-08-07
ROYAL FLASH (K952939)Royal Flash Enterprise Co. , Ltd.1995-08-07
REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER (K952407)Contour Fabricators of Florida, Inc.1995-08-07
POLYKOTE (K953299)Intl. Trade Management Co.1995-08-07
HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES (K945766)Ansell, Inc.1995-08-07
OPTX 20/20 (K953413)Neoptx, Inc.1995-08-07
PRECISE HOSPITAL FOAM CLEANER DISINFECTANT (K951512)Caltech Industries, Inc.1995-08-07
GOUVERNEUR AUDIGIER (K952758)Ets Gouverneur-Audigier1995-08-07
ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (K942200)Thantex Specialties, Inc.1995-08-07
BIOACCESS MARROW HARVEST SYSTEM (K953064)Bioaccess, Inc.1995-08-07
KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE (K952369)Physicians Consulting, Inc.1995-08-07
BALANCE MANAGER (K946229)Neurocom International, Inc.1995-08-04
URINARY DRAINAGE BAG (K951597)Key Medical Services, Inc.1995-08-04
MAGNETIC HDL CHOLESTEROL TEST (K944975)Reference Diagnostics, Inc.1995-08-02
5STRATEC SL 300 LIA-MAT (K950029)Nichols Institute Diagnostics1995-08-02
PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR (K946080)Portable Power Systems, Inc.1995-08-02
RELAXU-1 (K950411)Kinsei Shiatsu, Inc.1995-08-02
ZEUA MYCOPLASMA (K944417)Zeus Scientific, Inc.1995-08-01
BIO-RAD URINARY 5-HIAA BY HPLC (K952817)Bio-Rad1995-08-01
IV POLE/STAND (K952196)Valentine Intl. , Ltd.1995-07-31
SLOAN STA-DRI BOOTLEG LEGGING (K944276)Sloan Corp.1995-07-31
SLOAN STA-DRI SURGICAL JUMPSUIT (K944118)Sloan Corp.1995-07-31
HURRICANE (K952258)Hurricane Hardware, Inc.1995-07-31
ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES (K945948)Ampri Rubberware Industries Sdn Bhd1995-07-31
OTOSILK (K952203)Boston Medical Products, Inc.1995-07-31
CHAMPION, 3000 REBEL (K953427)Kuschall of America1995-07-31
CHAMPION, 3000 (K953428)Kuschall of America1995-07-31
COMPETITOR (K953426)Kuschall of America1995-07-31
REDI DRILL DRILL SYSTEM (K952609)Trebay Medical Corp.1995-07-31
CHAMPION, 1000 (K953429)Kuschall of America1995-07-31
COMFEEL PLUS PRESSURE RELIEF DRESSING (K951325)Richard Hamer Assoc., Inc.1995-07-31
BARRIER ALL FILM (K952234)Cottrell, Ltd.1995-07-31
ESSENTIAL SHAVER SYSTEM (K953096)Smith & Nephew Richards, Inc.1995-07-28
NIPLETTE (K952035)Avent America, Inc.1995-07-28
HEARING AID (K952658)Philips Hearing Instruments Co.1995-07-28
KARL STORZ DRILL (K952008)KARL STORZ Endoscopy-America, Inc.1995-07-26
PERSONAL PROGRAMMER 2000 (K952940)Siemens Hearing Instruments, Inc.1995-07-26
RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OPTION (K953266)Resound Corp.1995-07-26
MORE CHAIN POWDER FREE VINYL EXAMINATION GLOVES (K951007)Allerderm Laboratories, Inc.1995-07-26
BIO-COR COLLAGEN CORNEAL SHIELD (K944872)Bausch & Lomb Healthcare and Optics Worldwide1995-07-26
ROBOCAP (K952025)Pharmacia, Inc.1995-07-26
AMUCHINA (K952302)Amuchina Intl., Inc.1995-07-26
HUMID-VENT TRACH-VENT (K952845)Gibeck, Inc.1995-07-25
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