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

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RecordFirmDate
HI TECH IMPLANT, HT PHYSIO IMPLANT (K091913)By Dental Srl2009-10-30
ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES (K093300)Cardinal Health, Inc.2009-10-30
LOW & HIGH SPEED KIT (K090055)Dpm USA Corp.2009-10-27
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) (K091413)Alfa Wassermann, Inc.2009-10-26
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK) (K092301)Bettercare Plastic Products Co., Ltd.2009-10-22
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O (K092492)Wear Safe (Malaysia) Sdn. Bhd.2009-10-21
POWDER FREE EXAMINATION GLOVE (K092296)Bettercare Plastic Products Co., Ltd.2009-10-21
VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR (K092294)Bettercare Plastic Products Co., Ltd.2009-10-21
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) (K092411)Shen Wei (Usa), Inc.2009-10-21
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT (K092882)Diagnostic Hybrids, Inc.2009-10-21
EMS AIR-FLOW HANDY PERIO (K092289)E.M.S Electro Medical Systems S.A2009-10-20
POWDER FREE NITRILE EXAMINATION GLOVES, BLACK (K092034)Pt. Smartglove Indonesia2009-10-19
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 (K091065)J. Morita USA, Inc.2009-10-16
PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL (K091471)Cartagloves S.A.2009-10-15
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K092109)Zhangjiangang All Fine Rubber-Plastic Products Co.2009-10-09
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K092516)Zi BO Yuxiang Gloves Co., Ltd.2009-10-07
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN (K090568)Medline Industries, Inc.2009-10-02
MODEL SENTINELLA 102 (K092471)General Equipment For Medical Imaging, S.A.2009-10-02
PICCOLO MAGNESIUM TEST SYSTEM (K091910)Abaxis, Inc.2009-10-01
MODEL GDCH-2000 (K092851)Global Dental Direct, Inc.2009-09-29
ELECYS ANTI-CCP CALCHECK (K091601)Roche Diagnostics Corp.2009-09-25
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K082648)Tangshan Dar Plastic & Rubber Products Co. , Ltd.2009-09-25
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K092415)Shijiazhuang Elegance Plastic Product2009-09-25
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS (K091964)Procter & Gamble Co.2009-09-24
POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES (K091942)Zibo Intco Medical Products Co., Ltd.2009-09-21
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 (K092051)Microgenics Corp.2009-09-21
X-CUBE (K092758)Saeshin Precision Co., Ltd.2009-09-21
MICRO-TOUCH NITRA FREE (K092327)Ansell Healthcare Products, LLC2009-09-21
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES (K092100)Tangshan Hongxing Plastic Products Co., Ltd.2009-09-18
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES (K092000)Shangdong Zibo Shanchuan Medical Instruments Co.2009-09-18
POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED) (K092200)Gx Corporation Sdn Bhd2009-09-16
POWDERED VINYL PATIENT EXAMINATION GLOVES (K092416)Shijiazhuang Elegance Plastic Product2009-09-16
ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES (K092304)Cardinal Health, Inc.2009-09-15
LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 (K090104)DiaSorin, Inc.2009-09-09
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 (K092645)Fujirebio Diagnostics,Inc.2009-09-05
CLEARVIEW ADVANCED STREP A , MODEL 737-430 (K091489)Binax, Inc.2009-09-04
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS (K091652)Hartalega Sdn Bhd2009-09-04
STRONG IMPLANT HANDPIECES (K092412)Saeshin Precision Co., Ltd.2009-09-03
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (K083744)Binax, Inc.2009-09-01
EK/P. AERUGINOSA PNA FISH (K092393)Advandx, Inc.2009-09-01
VS-SENSE TEST (K091287)Common Sense , Ltd.2009-08-31
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (K092300)Diagnostic Hybrids, Inc.2009-08-28
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND (K083867)Beckman Coulter, Inc.2009-08-27
MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH (K092053)Handpiece Headquarters2009-08-20
KODAK 1500 INTRAORAL CAMERA (K091186)Carestream Health, Inc.2009-08-18
S. AUREUS PNA FISH (K091827)Advandx, Inc.2009-08-18
SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 (K091533)Garrison Dental Solutions2009-08-17
TISSU TRANS HARVEST TUBING (K092022)Shippert Medical Technologies Corp.2009-08-17
ADVIA CENTAUR DHEAS MASTER CURVE MATERIALS (K091123)Siemens Healthcare Diagnostics2009-08-14
IMM DENTAL IRRIGATION TUBING SET (K090727)Innovative Medical Manufacturing Co.2009-08-13
ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR (K083571)Purna Bina Sdn Bhd2009-08-13
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K090551)Tangshan Zhongpu Plastic Products Co., Ltd.2009-08-12
POWERED VINYL PATIENT EXAMINATION GLOVES (K091521)Shijiazhuang Century Plastic Co., Ltd.2009-08-10
ECOCEL (K083087)Polichem S.A2009-08-07
ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 (K091460)American Biological Technologies, Inc.2009-08-06
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 (K091333)Alfa Wassermann, Inc.2009-08-03
POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM (K083410)Wrp Asia Pacific Sdn. Bhd.2009-07-31
CHESSON LABS LIQUID BANDAGE (K083913)Chesson Laboratory Associates, Inc.2009-07-31
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K083408)Wrp Asia Pacific Sdn. Bhd.2009-07-31
NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) (K091422)Novapro Co., Ltd.2009-07-30
POWDERED VINYL PATIENT EXAMINATION GLOVES (K091662)Zhangjiagang Fengyuan Plastic Products Co., Ltd.2009-07-30
POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL (K083409)Wrp Asia Pacific Sdn. Bhd.2009-07-29
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (K090828)Ultrawin Sdn Bhd2009-07-28
NAVIJECT SUB2-1P, MODEL: LP604430 (K092023)Medicel AG2009-07-28
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K091663)Zhangjiagang Fengyuan Plastic Products Co., Ltd.2009-07-27
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (K091147)Smart Glove Corp. Sdn Bhd2009-07-27
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K091661)Zhang Jia Gang Huayuan Plastic Co. , Ltd.2009-07-27
E-STATIS 40 SYSTEM (K090937)Scican , Ltd.2009-07-24
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT (K083074)Advandx, Inc.2009-07-24
RAMP RSV ASSAY (K091235)Response Biomedical Corp.2009-07-24
NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED) (K091421)Novapro Co., Ltd.2009-07-23
LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER (K090766)Lifeloc Technologies, Inc.2009-07-23
VINYL POWDER FREE EXAMINATION GLOVE (K091429)Shun DA (Xinghua) Co., Ltd.2009-07-22
POWDERED VINYL PATIENT EXAMINATION GLOVES (K082647)Tangshan Dar Plastic & Rubber Products Co. , Ltd.2009-07-22
ALATECH POWDER FREE LATEX EXAMINATION GLOVE (K083761)Alatech Healthcare, LLC2009-07-22
VINYL POWDER FREE EXAMINATION GLOVE (K091383)Shun Tong Co., Ltd.2009-07-22
VINYL POWDERED EXAMINATION GLOVE (K091384)Shun Tong Co., Ltd.2009-07-20
EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES (K090734)Medica Corp.2009-07-17
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K091523)Shijiazhuang Century Plastic Co., Ltd.2009-07-09
XPERT C. DIFFICILE (K091109)Cepheid2009-07-09
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM (K082871)Sis Ltd., Surgical Instrument Systems2009-07-09
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) (K091681)Entellus Medical, Inc.2009-07-08
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES (K091431)Zibo Yusheng Plastic Products Co., Ltd.2009-07-08
POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR (K090194)Shen Wei (Usa), Inc.2009-07-07
HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 (K091482)Danyang Huayi Medical Supply & Equipment Co, Ltd.2009-07-06
ELECSYS PRECICONTROL UNIVERSAL (K090541)Roche Diagnostics2009-07-02
SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS (K090336)Sunmax Enterprise Shanghai Co. , Ltd.2009-07-01
CONTRA-ANGLE HANDPIECE KOMET OS30 (K090548)W&H Dentalwerk Buermoos GmbH2009-06-30
CERAMIC PEDATRIC PREFORMED CROWN (K091362)Ez-Pedo, Inc.2009-06-29
VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET (K091225)Maine Standards Co.2009-06-25
E. COLI PNA FISH (K082068)Advandx, Inc.2009-06-25
VINYL POWDERED EXAMINATION GLOVE (K091427)Shun DA (Xinghua) Co., Ltd.2009-06-23
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM (K083305)Wrp Asia Pacific Sdn. Bhd.2009-06-18
TREVAIR CHAIR (K091478)Patmont Motor Werks, Inc.2009-06-18
INFANT SLEEP BEANIE (K082367)Life Innovations, LLC2009-06-12
EPIPHANY INJECTION SYSTEM (K090161)Staar Surgical Co.2009-06-09
SERAQUEST EBV EA-D IGG TEST (K091260)Quest Intl., Inc.2009-06-08
RES-Q INFANT WEDGE AND SLING (K090284)Cr Enterprises, LLC2009-06-05
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (K090824)Becton, Dickinson & CO2009-06-02
POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE). (K090412)Gx Corporation Sdn Bhd2009-06-01
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