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

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RecordFirmDate
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS (K033162)Cliniqa Corporation2003-10-10
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (K032881)Diagnostic Products Corp.2003-10-10
TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM (K032471)Titronics Research & Development Co.2003-10-10
MAXTER STERILE POWDERED LATEX SURGICAL GLOVES (K032467)Maxter Glove Manufacturing Sdn Bhd2003-10-10
RUBBERCARE POWDERED LATEX EXAMINATION GLOVES (K032201)Perusahaan Pelindung Getah (M) Sdn Bhd2003-10-10
POWDER FREE VINYL EXAMINATION GLOVE (K032071)Shanghai Foremost Plastic Industrial Co., Ltd.2003-10-10
MAS PAR TDM (K032826)Medical Analysis Systems, Inc.2003-10-09
I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET (K031873)I-Stat Corporation2003-10-07
BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW (K032323)Long First (Xiamen) Plastics Co., Ltd.2003-10-07
3M LIQUID BANDAGE, MODEL 120-LB (K031263)3M Company2003-10-07
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM (K024072)Duckworth & Kent, Ltd.2003-10-06
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES (K032668)Kingswell International, Inc.2003-10-06
LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX (K031386)Lalan Gloves (Pvt) , Ltd.2003-10-06
DISPOSABLE POWDER FREE VINYL EXAM GLOVES (K032630)Kingswell International, Inc.2003-10-03
MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K (K032234)Mk-Dent GmbH2003-10-02
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES (K032616)Elite International, Inc.2003-10-02
CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, (K022505)NOUVAG AG2003-10-01
PHEM-ALERT (K032161)Femtek,Llc.2003-09-30
RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T, (K032402)Convaid Products, Inc.2003-09-24
VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR (K031944)Arista Latindo Industrial Ltd. P.T2003-09-23
STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING (K031669)P.T. Saptindo Surgica2003-09-23
STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING (K031670)P.T. Saptindo Surgica2003-09-23
PERSONNA PLUS SAFETY SCALPEL SYSTEM (K032242)Omi Manufacturing Pty., Ltd.2003-09-23
AUDIT MICROCONTROLS MICROFD BNP CONTROL (K032122)Aalto Scientific, Ltd.2003-09-09
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE (K031108)Shijiazhuang Great Vision Plastic Products Co., LT2003-09-08
MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES (K032549)Matang Mfg. Sdn. Bhd.2003-09-08
N/T PROTEIN CONTROL (K032237)Dade Behring, Inc.2003-09-05
NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR APPLE OR PEPPERMINT SCENTING PLUS A PROTEIN (K032293)Sgmp Co., Ltd.2003-08-28
NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING (K032294)Sgmp Co., Ltd.2003-08-28
ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL (K032453)Bionostics, Inc.2003-08-28
ELCACAM (K032070)A-Dec, Inc.2003-08-27
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR (K032272)Est International Corporation2003-08-26
DISPOSABLE POWERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR (K032236)Est International Corporation2003-08-26
DISPOSABLE N-PE MICKROKERATOME BLADES (K032297)Oasis Medical, Inc.2003-08-26
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS (K031921)Cliniqa Corporation2003-08-25
INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 (K032341)Sota Precision Optics, Inc.2003-08-25
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50 (K032464)Wrp Asia Pacific Sdn. Bhd.2003-08-22
VERSATREK (K032306)Trek Diagnostic Systems, Inc.2003-08-22
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER (K030574)Glustitch, Inc.2003-08-21
DENTAPORT ZX (K031204)J. Morita USA, Inc.2003-08-21
CENTURION SES EPIKERATOME (K031735)Ciba Vision Corporation2003-08-21
ELECSYS PRECICONTROL TROPONIN T (K031990)Roche Diagnostics Corp.2003-08-20
ELECYS SHBG CALCHECK (K031698)Roche Diagnostics Corp.2003-08-20
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET) (K032077)Seal Polymer Industries Bhd.2003-08-19
GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE (K032011)Pt. Wrp Buana Multicorpora2003-08-19
MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL (K032335)Medical Analysis Systems, Inc.2003-08-19
SIROTORQUE L (K031584)Sirona Dental Systems GmbH2003-08-19
GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE (K032010)Pt. Wrp Buana Multicorpora2003-08-19
FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT (K030730)Diagnostics Biochem Canada, Inc.2003-08-18
POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED (K031157)Qingdao Bestex Rubber & Plastic Products Co., Ltd.2003-08-15
DISPOSABLE POWDERED VINYL EXAM GLOVES (K032190)Synmertex Co, Ltd.2003-08-14
DISPOSABLE POWDER FREE VINYL EXAM GLOVES (K032172)Synmertex Co, Ltd.2003-08-14
AUSAM TOTAL ALBUMIN ASSAY (K013643)Ausam Biotecthnologies, Inc.2003-08-14
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (K032246)Starplex Scientific, Inc.2003-08-13
LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE (K030529)Jda (Tianjin) Plastic Rubber Co., Ltd.2003-08-08
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS (K031577)Cliniqa Corporation2003-08-06
ELECSYS SHBG IMMUNOASSAY (K031717)Roche Diagnostics Corp.2003-08-05
POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED (K031625)Perusahaan Getah Asas Sdn. Bhd.2003-08-01
BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED (K031768)Perusahaan Getah Asas Sdn. Bhd.2003-08-01
DENTISEPTIC HPC (K031851)Bethel, Inc.2003-08-01
SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (K031576)Surgitech, Inc.2003-07-31
SHOCKWAVE SUSPENSION WHEELCHAIR (K032123)Per4max Medical, LLC2003-07-31
EARLYDETECT MENOPAUSE TEST FOR FSH (K030058)Early Detect, Inc.2003-07-30
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC (K032089)Roche Diagnostics Corp.2003-07-30
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR (K032007)Pt. Wrp Buana Multicorpora2003-07-28
VINYL EXAM GLOVES, POWDER-FREE, YELLOW (K031854)Shanghai Jiawang Industrial Co. , Ltd.2003-07-25
NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE (K031580)Green Prospect Sdn Bhd2003-07-25
STAINLESS STEEL AQUATIC WHEELCHAIR (K031910)Db Perks & Associates , Ltd.2003-07-25
NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH PROTEIN LABELING, CONTAINS 50 MICROG (K031581)Green Prospect Sdn Bhd2003-07-24
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS (K031575)Cliniqa Corporation2003-07-23
NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 (K031173)Needle Tech Products, Inc.2003-07-23
BRODA MODEL 587 MANUAL WHEELCHAIR (K032133)Broda Ent., Inc.2003-07-21
NATURALASE LP ND:YAG LASER (K031828)Focus Medical, LLC2003-07-17
OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (K032092)Olympus Optical Co., Ltd.2003-07-16
MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL (K031890)Medical Analysis Systems, Inc.2003-07-16
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (K031044)Clinical Data, Inc.2003-07-15
ESTYLUS ELECTRIC MOTOR SYSTEM (K031145)Dentsply Intl.2003-07-15
BACT/ALERT MP CULTURE BOTTLES (PLASTIC) (K031737)bioMerieux, Inc.2003-07-14
ACON STREP A RAPID TEST DEVICE (K031784)ACON Laboratories, Inc.2003-07-14
INJECTOR (K023737)Anton Meyer & Co. , Ltd.2003-07-14
C. DIFF CHEK - 60 (K030992)Techlab, Inc.2003-07-11
AUTION JET AJ-4270 URINE ANALYZER (K030600)International Remote Imaging Systems2003-07-11
BUTLER GUM PROPHY PASTE WITH NOVAMIN (K024343)Usbiomaterials Corp.2003-07-11
C. DIFF CHEK - 30 (K030991)Techlab, Inc.2003-07-11
COBAS INTEGRA CHOLESTEROL GEN. 2 (K031824)Roche Diagnostics Corp.2003-07-09
VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR (K031913)Arista Latindo Industrial Ltd. P.T2003-07-09
PROPHYPEARLS (K031868)Kavo America2003-07-09
SECQUIRE CELL SEPARATOR (K024080)Perfusion Partners & Assoc., Inc.2003-07-02
URICHEMTRAK LIQUID ASSAYED URINE CONTROL (K031441)Medical Analysis Systems, Inc.2003-07-01
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL (K031392)Medical Analysis Systems, Inc.2003-07-01
FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (K031754)Pt. Mandiri Inti Buana2003-06-30
APEX ELECTRIC HANDPIECE SYSTEM (K031540)Lares Research, Inc.2003-06-30
YA MEI FIRST AID KIT (K031130)Ya Mei Technology Co., Ltd.2003-06-27
EBV VCA-P18 IGG ELISA (K030863)Panbio Limited2003-06-27
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE (K031414)Perusahaan Getah Asas Sdn. Bhd.2003-06-26
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED (K031591)Perusahaan Getah Asas Sdn. Bhd.2003-06-26
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL (K031644)Bayer Healthcare, LLC2003-06-25
DETECTAR, MODEL N123-MI (K023367)Neks Technologies2003-06-25
BD VIPER INSTRUMENT (K023955)Becton, Dickinson & CO2003-06-24
C-1890 (K023896)Anodia Systems2003-06-19
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