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

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RecordFirmDate
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW (K070038)Super Safe Plastic Products Co., Ltd.2007-03-23
OLYMPUS TRIGLYCERIDE TEST SYSTEM (K063804)Olympus America, Inc.2007-03-23
POWDER FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR (K070097)Gx Corporation Sdn Bhd2007-03-23
POWDERED (WHITE) VINYL PATIENT EXAMINATION (K070027)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-03-22
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) (K063627)Smart Glove Corp. Sdn Bhd2007-03-20
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH) (K062919)Shen Wei (Usa), Inc.2007-03-20
POWDER FREE NITRILE BLUE EXAMINATION GLOVE (K061504)Liwe Trading2007-03-19
TDM CONTROL SET, MODEL CAT# 04521536 (K070200)Roche Diagnostics Corp.2007-03-19
SILVERLON DIRECT PRESSURE WOUND DRESSING (K984207)Argentum International, LLC2007-03-19
POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW (K070188)Hong DI Plastic Products Co., Ltd.2007-03-19
SECURE ARTERIAL BLOOD SAMPLING SYSTEM (K070340)Smiths Medical Asd, Inc.2007-03-15
ADVACOAT SINUS GEL AND STENT (K070496)Carbylan Biosurgery2007-03-15
SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE (K063581)Pt Mahakarya Inti Buana2007-03-15
REPROCESSED HEART STABILIZERS AND POSITIONERS (K063844)Sterilmed, Inc.2007-03-15
NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES (K070072)Medtexx Manufacturing Sdn. Bhd.2007-03-15
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR (K070096)Gx Corporation Sdn Bhd2007-03-14
AUDIT MICROCV LIPIDS LINEARITY SET (LOW) (K070223)Aalto Scientific, Ltd.2007-03-13
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH (K060452)Neo-Genesis2007-03-13
MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL (K070084)Est. Anthogyr2007-03-08
OPTI (K063646)Camsight Co., Inc.2007-03-07
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (K063694)Bausch & Lomb, Inc.2007-03-07
POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K070026)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-03-07
VAP-NT CHOLESTEROL TEST (K062026)Atherotech, Inc.2007-03-06
ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES (K063776)Bright Element Sdn Bhd2007-03-02
MAXHEALTH MECHANICAL WHEELCHAIR, K1 (K070176)Maxhealth Corp.2007-03-01
POWDERED VINYL PATIENT EXAMINATION GLOVES (K070145)Wuxi Shenzhou Plastic Products Co., Ltd.2007-02-28
SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K063471)Shijiazhuang Junfei Plastic Products Co., Ltd.2007-02-28
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED (K062764)Kossan Latex Industries(M)Sdn Bhd2007-02-27
ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE (K063777)Bright Element Sdn Bhd2007-02-23
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH (K063608)Dade Behring, Inc.2007-02-23
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K070149)Wuxi Shenzhou Plastic Products Co., Ltd.2007-02-23
POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW (K070042)Super Safe Plastic Products Co., Ltd.2007-02-23
POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED) (K070076)Jiangsu Cureguard Glove Co., Ltd.2007-02-22
BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 (K063704)Beks Incorporated2007-02-20
POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K070037)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-02-20
STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE (K062565)Princeton BioMeditech Corp.2007-02-20
BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (K062527)Multisafe Sdn. Bhd.2007-02-20
POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K070030)Super Safe Plastic Products Co., Ltd.2007-02-16
DOWN PAK (K070246)Endo Twinn B.V.2007-02-16
EXCEL CONTRA ANGLE HANDPIECE (K061897)Orthosource, Inc.2007-02-14
IMMUNOCARD STAT! EHEC, MODEL 751630 (K062546)Meridian Bioscience, Inc.2007-02-14
POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K070187)Hong DI Plastic Products Co., Ltd.2007-02-13
PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 (K070287)Photonic Optische Gerate GmbH & Cokg2007-02-12
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K070075)Jiangsu Cureguard Glove Co., Ltd.2007-02-09
NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET (K063477)Novamed, LLC2007-02-09
POWDERED VINYL PATIENT EXAMINATION GLOVES (K070008)Zibo Hengde Plastic & Rubber Products Co., Ltd.2007-02-08
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (K070043)Super Safe Plastic Products Co., Ltd.2007-02-08
POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR) (K063522)Hl Rubber Industries Sdn Bhd2007-02-08
POWDERED VINYL PATIENT GLOVE (K070046)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-02-07
CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT (K070297)Dental Air Solutions of Nc, Inc.2007-02-05
NISSIN PEDIATRIC SERIES WHEELCHAIR (K063521)Nissin Medical, Inc.2007-02-05
MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE (K070001)Mti Precision Products2007-02-02
LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047 (K063855)Liberty Healthcare Group, Inc.2007-02-01
COBAS INTEGRA CERULOPLASMIN (K062379)Roche Diagnostics Corp.2007-01-31
POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION (K070044)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-01-29
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (K070040)Super Safe Plastic Products Co., Ltd.2007-01-26
FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT (K070196)Hr Dental Products, Inc.2007-01-26
TECO MICROALBUMIN 2-1 COMBO STRIPS (K061419)Teco Diagnostics2007-01-26
INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC (K070155)Osseo Scientific, LLC2007-01-25
DERMATHERAPY, MODEL 22216 (K061242)Precision Fabrics Group, Inc.2007-01-25
ACTIM PROM AND CONTROLS (K061886)Medix Biochemica2007-01-25
POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR) (K063524)Hl Rubber Industries Sdn Bhd2007-01-23
POWDERED VINYL PATIENT EXAMINATION GLOVE (K070035)Super Safe Plastic Products Co., Ltd.2007-01-23
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 (K060818)Biokit, S.A.2007-01-23
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199 (K063451)Gen-Probe, Inc.2007-01-22
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K070006)Zibo Hengde Plastic & Rubber Products Co., Ltd.2007-01-19
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (K063208)Diagnostic Chemicals , Ltd.2007-01-19
FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50 (K063736)Pdg Product Design Group, Inc.2007-01-17
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (K063688)The Anspach Effort, Inc.2007-01-16
CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (K062965)Kossan Latex Industries(M)Sdn Bhd2006-12-22
INTERDRY TEXTILE WITH SILVER (K061615)Milliken Chemical2006-12-22
ALLERGEAZE PATCH TEST CHAMBERS (K063160)Smartpractice2006-12-22
ENTEROCOCCUS FAECALIS PNA FISH (K063127)Advandx, Inc.2006-12-22
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) (K062950)Hartalega Sdn Bhd2006-12-21
BIOGEL ECLIPSE INDICATOR UNDERGLOVE (K062847)Molnlycke Health Care Us, LLC2006-12-20
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS (K062971)Akers Biosciences, Inc.2006-12-18
OSSPRAY CLEANING COMPOUND (K062502)Ospray, Ltd.2006-12-15
SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW (K062714)Baoding Guanzhong Glove Co., Ltd.2006-12-15
HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES (K062947)Peng Lim Enterprise Co., Ltd.2006-12-14
C-U2 (K062897)Cefla S.C.R.L.2006-12-14
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04 (K062612)Rayner Surgical, Inc.2006-12-13
TF ROTARY NICKEL TITANIUM FILE (K062856)Ormco Corp.2006-12-13
BIOSTAR OIA SHIGATOX (K061889)Inverness Medical-Biostar, Inc.2006-12-12
BAND-AID(R) BRAND LIQUID BANDAGE (K062602)Johnson & Johnson Consumer Companies, Inc.2006-12-11
ISECURE SYRINGE CARTRIDGE HOLDER (K063180)Hospira, Inc.2006-12-11
BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062211)Bio-Rad Laboratories, Inc.2006-12-08
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B (K062948)Cepheid2006-12-08
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES (K063214)Ever Light Plastic Products Co., Ltd.2006-12-08
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K062213)Bio-Rad Laboratories, Inc.2006-12-08
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES (K063215)Ever Light Plastic Products Co., Ltd.2006-12-08
POWDER FREE LATEX EXAMINATION GLOVES, BLACK (K062709)Pt. Maja Agung Latexindo2006-12-06
STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM (K061805)Diagnostica Stago, Inc.2006-12-06
ESA LEADCARE II LEAD CONTROL (K063398)Bionostics, Inc.2006-12-05
URITEST 10 URINALYSIS REAGENT STRIPS (K052719)Arj Medical, Inc.2006-12-05
EVER LIGHT PLASTIC PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K063213)Ever Light Plastic Products Co., Ltd.2006-12-05
ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 (K063308)Carbylan Biosurgery2006-12-04
MISSION TRINITY B (K062674)Diamond Diagnostics, Inc.2006-12-01
SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (K062313)Pt Mahakarya Inti Buana2006-11-30
POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (K062688)Ug Healthcare (Usa), Inc.2006-11-30
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N (K062812)Thunder Tiger Corp.2006-11-28
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