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

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RecordFirmDate
ALGISITE M (K983210)Smith & Nephew, Inc.1998-12-10
ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE (K983833)Westaim Biomedical, Inc.1998-12-10
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO (K983801)Zeus Scientific, Inc.1998-12-10
GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P (K983183)Bien Air USA, Inc.1998-12-10
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (K984277)Medical Analysis Systems, Inc.1998-12-09
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K983804)Zeus Scientific, Inc.1998-12-08
CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE (K983723)Kossan Latex Industries(M)Sdn Bhd1998-12-07
ARSOFT (K983146)Alliance Rubber Products Sdn. Bhd.1998-12-07
SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE (K981665)Bio-Medical Sciences, Inc.1998-12-07
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS (K984011)Ortho-Clinical Diagnostics, Inc.1998-12-07
POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE (K983721)Kossan Latex Industries(M)Sdn Bhd1998-12-07
BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY (K983345)Bayer Corp.1998-12-07
POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K981917)Oon Corp. Resources1998-12-07
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE (K983725)Omnigrace , Ltd.1998-12-07
NITRILE LATEX POWDER FREE EXAMINATION GLOVE (K983825)Top Glove Sdn. Bhd.1998-12-04
PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE (K982885)Shanghai Poseidon Plastic Products Co., Ltd.1998-12-04
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES (K983645)Shijiazhuang Great Eagle Plastic Products Co., Ltd.1998-12-04
AMERSE 2 (K983947)STERIS Corporation1998-12-04
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (K983129)Staar Surgical Co.1998-12-04
NITRILE LATEX POWDERED EXAMINATION GLOVE (K983816)Top Glove Sdn. Bhd.1998-12-04
LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 (K984071)Bio-Rad1998-12-03
ERADIC-ALL (K981171)Theratechnologies, Inc.1998-12-02
BARRON MICROKERATOME SYSTEM, MODEL B2000 (K983317)Barron Precision Instruments, LLC1998-12-02
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 (K983503)Boehringer Mannheim Corp.1998-12-01
MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT (K983847)Germiphene Corp.1998-12-01
UNISEAL GLOVES LOW PROTEIN POWDERED (K981979)American Healthcare Products (M) Sdn Bhd1998-11-30
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) (K983244)Trek Diagnostic Systems, Inc.1998-11-30
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM (K982716)Omnigrace (Thailand) , Ltd.1998-11-30
MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE (K982877)Matang Mfg. Sdn. Bhd.1998-11-30
NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES (K983240)Johnson & Johnson Medical, Div. of Ethicon, Inc.1998-11-30
POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED (K983532)Shanghai Antares Industries, Inc.1998-11-30
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH (K983869)Caltech Industries, Inc.1998-11-30
NON-STERILE E.P. LATEX EXAMINATION GLOVE (K982453)Ansell Perry1998-11-30
POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED (K983531)Shanghai Antares Industries, Inc.1998-11-30
NITRILE POWDER-FREE UNISEAL GLOVES (K982218)American Healthcare Products (M) Sdn Bhd1998-11-30
DOMINATOR (K983681)Impact Wheelchair Manufacture, Inc.1998-11-27
ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 (K984070)Bio-Rad1998-11-25
EA-D IGM ELISA TEST SYSTEM (K982350)Columbia Bioscience, Inc.1998-11-25
SPECTRUM SMALL FRY (K983859)Freedom Designs, Inc.1998-11-25
ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 (K984073)Bio-Rad1998-11-25
BIOSTREP A-DIRECT STREP A ANTIGEN TEST (K983386)Princeton BioMeditech Corp.1998-11-25
EBNA-1 IGM ELISA TEST SYSTEM (K982348)Columbia Bioscience, Inc.1998-11-25
VCA IGM ELISA TEST SYSTEM (K982352)Columbia Bioscience, Inc.1998-11-25
ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 (K984072)Bio-Rad1998-11-24
SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE (K982416)Shun Thai Rubber Gloves Industry Co., Ltd.1998-11-24
ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES (K982965)Richard Wolf Medical Instruments Corp.1998-11-23
SPECTRUM SPIRIT (K983763)Freedom Designs, Inc.1998-11-23
ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05 (K984074)Bio-Rad1998-11-20
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED (K981975)Siam Sempermed Corp., Ltd.1998-11-20
PROSPECT CAMPYLOBACTER MICROPLATE ASSAY (K982315)Alexon - Trend, Inc.1998-11-18
AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 (K983168)Ora Innovations, Inc.1998-11-18
ABBOTT TESTPACK PLUS H. PYLORI (K982362)Abbott Laboratories1998-11-18
BREATHTIQUE TONGUE SCRAPER (K983087)Custom Medical Arts, Inc.1998-11-18
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT (K983113)Syntron Bioresearch, Inc.1998-11-18
ABBOTT ARCHITECT TESTOSTERONE (K983212)Abbott Laboratories1998-11-18
CARDIAC MARKER CONTROL MODULE, MODEL CCCM (K983971)Diagnostic Products Corp.1998-11-18
25-HYDROXYVITAMIN D 125I RIA KIT (K983617)DiaSorin, Inc.1998-11-16
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 (K983578)Bio-Rad1998-11-12
ALLDRESS, ABSORBENT FILM DRESSING (K983554)Molnlycke Health Care, Inc.1998-11-10
FIBREKOR POST SYSTEM (K983266)Jeneric/Pentron, Inc.1998-11-09
LOW PH PHENOLIC 256 (K983585)Central Solutions, Inc.1998-11-06
VINYL EXAMINATION GLOVES, POWDER FREE (K982933)General Gloves Corp.1998-11-06
IRRIGATION SYRINGE KIT (K982435)Sub-Q, Inc.1998-11-06
EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK (K983608)Yty Industry (Manjung) Sdn Bhd1998-11-05
POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES (K983612)Shanghai Jiatai Plastic Products Co., Ltd.1998-11-05
POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES (K981064)P.T. Irama Dinamika Latex1998-11-05
H-RAY (K982720)Shijiazhuang Hongray Plastic Products Co., Ltd.1998-11-05
VINYL EXAM GLOVES, POWDER FREE (K983494)Glormed Intl., Inc.1998-11-05
QUANTA LITE H. PYLORI IGG ELISA (K982790)Inova Diagnostics, Inc.1998-11-04
BIO-2000 (K973765)Micrylium Laboratories1998-11-04
ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS (K983285)Engle Dental Systems1998-11-04
VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY (K983507)Ortho-Clinical Diagnostics, Inc.1998-11-04
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (K983513)Ortho-Clinical Diagnostics, Inc.1998-11-03
CITREX HOSPITAL SPRAY DISINFECTANT (K982985)Caltech Industries, Inc.1998-11-02
LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED (K981600)Young Innovations, LLC Dba Plak Smacker1998-11-02
UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE) (K982611)Uniject Gloves Pcl1998-11-02
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K983207)Shijiazhuang Great Eagle Plastic Products Co., Ltd.1998-10-30
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE (K982131)Ansell Edmont Industrial, Inc.1998-10-29
SEMPERMED SURGEONS' GLOVES - SUPREME (K981096)Semperit Technische Produkte Gesellshaft1998-10-29
WISE (II) IMAGE MANAGEMENT SYSTEM (K983447)Sectra-Imtec AB1998-10-29
CLEARPLAN EASY FERTILITY MONITOR (K981207)Unipath , Ltd.1998-10-28
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 (K983709)Beckman Coulter, Inc.1998-10-28
CHEMSTRIP 101 URINE ANALYZER (K983510)Boehringer Mannheim Corp.1998-10-27
3M TEGASORB HYDROCOLLOID DRESSING (K982893)3M Company1998-10-26
3M TEGASORB THIN HYDROCOLLOID DRESSING (K982892)3M Company1998-10-26
ZIPPIE GS, MODEL # EIZGS (K983639)Sunrise Medical, Inc.1998-10-25
MG (K981791)Abbott Laboratories1998-10-23
LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE (K982593)Dentalez Group1998-10-22
BIODERM FOAM WOUND DRESSING (K982778)Bioderm, Inc.1998-10-21
HOSPAL TIPSTOP (K982818)Gambro Healthcare1998-10-21
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 (K983416)Boehringer Mannheim Corp.1998-10-21
UROSURGE UROTHERM FLUID WARMING SYSTEM (K965136)Princeton Regulatory Assoc.1998-10-16
BIOCLEAR CONCENTRATE (K981565)Waggoner Product Development1998-10-15
KSEA ENDOSCOPES FOR DENTAL PROCEDURES (K982658)KARL STORZ Endoscopy-America, Inc.1998-10-15
VINYL PATIENT EXAMINATION GLOVE, POWDERED (K981360)Glormed Intl., Inc.1998-10-15
TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K982872)Tg Medical Sdn. Bhd.1998-10-15
EXTRA-CARE POWDER-FREE EXAMINATION GLOVE (K983175)Ultrawin Sdn Bhd1998-10-13
DISPOSABLE VINYL EXAM GLOVES, POWDERED (K982687)Shanghai Antares Industries, Inc.1998-10-09
MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K982691)Perusahaan Intan Emas Sdn. Bhd.1998-10-09
BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC (K983492)Boehringer Mannheim Corp.1998-10-09
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