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

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RecordFirmDate
AT HOME OVULATION TEST, MODEL 9032 (K021409)Phamatech, Inc.2002-05-24
MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE (K021465)Industrial Clothings, Ltd.2002-05-22
SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE) (K021013)Smart Glove Corp. Sdn Bhd2002-05-22
LATEX SURGEONS GLOVE (POWDER FREE) (K014283)Brightway Gloves Pvt. , Ltd.2002-05-22
CARBON POST (K012496)J. Morita USA, Inc.2002-05-17
SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES (K021001)Shanghai Glovmax Enterprise Co.,Ltd2002-05-16
DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE (K021396)Wrp Specialty Products Sdn. Bhd.2002-05-16
ACCOMMODATOR WHEELCHAIR, MODEL #2000X (K021145)Marken International, Inc.2002-05-16
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM (K021059)Syntex Healthcare Products Co., Ltd.2002-05-14
SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM (K021058)Syntex Healthcare Products Co., Ltd.2002-05-14
GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES (K021308)Glovco (M) Sdn. Bhd.2002-05-14
IRON-PC-SL ASSAY MODEL # 151-10, 151-26 (K020816)Diagnostic Chemicals , Ltd.2002-05-14
LATEX SURGEONS GLOVE (POWDERED) (K014278)Brightway Gloves Pvt. , Ltd.2002-05-14
GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER (K021258)Germ Terminator Corporation2002-05-10
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 (K020724)Dade Behring, Inc.2002-05-09
ONLINE POWDER FREE, LATEX EXAMINATION GLOVES (K020865)Apl Products Sdn. Bhd.2002-05-08
PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM (K021065)Primus Gloves Private , Ltd.2002-05-08
WET CHAMBER (K020781)Kinetic Concepts, Inc.2002-05-06
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE (K020365)3t Medical Systems, LLC2002-05-03
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 (K014068)W&H Dentalwerk Buermoos GmbH2002-05-03
SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE (K020751)Syntex Healthcare Products Co., Ltd.2002-05-02
SAFE SHIELD POWEDER-FREE LATEX EXAMINATION GLOVES (K020053)Safe Shield Co., Ltd.2002-05-01
FRC POSTEC (K013802)Ivoclar Vivadent, Inc.2002-05-01
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL (K021155)Medical Analysis Systems, Inc.2002-04-29
BACT/ALERT SN CULTURE BOTTLE (K021123)bioMerieux, Inc.2002-04-26
ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K020838)Ar Alliance Healthcare Sdn. Bhd.2002-04-23
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE) (K020868)Seal Polymer Industries Bhd.2002-04-22
LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 (K020610)Bio-Rad2002-04-22
ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE (K020918)Eci Medical Technologies, Inc.2002-04-19
BLADEWORKS MICROKERATOME BLADE, MODEL 7061 (K020079)Blade Works, Inc.2002-04-19
BACT/ALERT FN CULTURE BOTTLE (K020815)bioMerieux, Inc.2002-04-18
BACT/ALERT PF CULTURE BOTTLE (K020923)bioMerieux, Inc.2002-04-18
BACT/ALERT SA CULTURE BOTTLE (K020931)bioMerieux, Inc.2002-04-18
BACT/ALERT FA CULTURE BOTTLE (K020813)bioMerieux, Inc.2002-04-17
CARESIDE TRGLYCERIDE (K020488)Careside, Inc.2002-04-15
LIQUICHEK URINE CHEMISTRY CONTROL (K020817)Bio-Rad Laboratories, Inc.2002-04-12
ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS (K020575)Elan Diagnostics2002-04-12
INTRAORAL CAMERA ME-15 (K020206)Dent Corp. Research & Development2002-04-11
GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) (K020363)Great Glove Sdn Bhd2002-04-10
SURGIC IV IMPLANT CONTROL UNIT (K020327)Nakanishi, Inc.2002-04-08
REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE (K020308)Ssl America'S, Inc.2002-04-03
ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (K020621)Arthrocare Corp.2002-03-28
GLASS POST (K012849)J. Morita USA, Inc.2002-03-27
CAT ACTIVE WHEELCHAIR (K020737)Movingpeople.Net2002-03-21
VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 (K020450)Maine Standards Co.2002-03-21
LATEX EXAMINATION GLOVES (POWDER FREE) (K014279)Brightway Gloves Pvt. , Ltd.2002-03-20
LATEX EXAMINATION GLOVE (POWDERED) (K014280)Brightway Gloves Pvt. , Ltd.2002-03-20
IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 (K020237)Consolidated Technology2002-03-19
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY (K020217)Bayer Diagnostics Corp.2002-03-15
GAZELLE WHEELCHAIR (K020536)Alum Creek Wheelchair Co., Inc.2002-03-15
COMFORT WHEELCHAIRS (K020451)Comfort Orthopedic Co., Ltd.2002-03-14
STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) (K014230)Supermax Glove Manufacturing Sdn Bhd2002-03-13
RBM (K020480)Smith & Nephew, Inc.2002-03-12
VISTITOME 20-10 MICROKERATOME (K014000)Biovision AG2002-03-11
EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS (K020094)Regulatory Insight, Inc.2002-03-08
BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR (K020188)Taiwan Armada Enterprise Co., Ltd.2002-03-08
SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS (K020100)Regulatory Insight, Inc.2002-03-08
POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS (K013267)Siam Sempermed Corp., Ltd.2002-03-08
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS (K013662)Quantimetrix Corp.2002-03-08
BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR (K020472)Taiwan Armada Enterprise Co., Ltd.2002-03-08
NON-EUGENOL TEMPORARY CEMENT (K020158)J. Morita USA, Inc.2002-03-07
ELECSYS ANTI-TG CALCHECK (K020369)Roche Diagnostics Corp.2002-03-06
ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES (K020359)Ar Alliance Healthcare Sdn. Bhd.2002-03-06
CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA (K013774)Supermax Sdn Bhd2002-03-05
SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) (K013821)Top Quality Mfg., Inc.2002-03-05
MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) (K014044)Notal Vision, Inc.2002-03-04
LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE (K014087)Latexx Manufacturing Sdn.Bhd.2002-03-04
AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON (K020137)Aseptico, Inc.2002-03-04
REPROCESSED DISPOSABLE TROCARS (K013987)Adven Medical2002-03-01
MODIFICATION TO VIGIL LIPID CONTROL (K020521)Beckman Coulter, Inc.2002-03-01
SANDHILL SCIENTIFIC PEDIATEC PH PROBE (K013951)Sandhill Scientific, Inc.2002-02-28
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM (K013819)Sierra Diagnostic, LLC2002-02-28
SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT (K014110)Siam Sempermed Corp., Ltd.2002-02-28
SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E (K014112)Siam Sempermed Corp., Ltd.2002-02-28
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE (K020493)Syntex Healthcare Products Co., Ltd.2002-02-26
AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM (K013953)Supermax Glove Manufacturing Sdn Bhd2002-02-26
LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE (K013996)Pt. Maja Agung Latexindo2002-02-26
VINYL EXAMINATION GLOVES STERILE POWEDERED (K020044)Primus Gloves Private , Ltd.2002-02-26
TORFLEX TRANSSEPTAL GUIDING SHEATH (K013919)Baylis Medical Co., Inc.2002-02-22
NEOCALEX (K013993)Stephen M Koral, Dmd2002-02-22
SPIRABRUSH CX BIOPSY INSTRUMENT (K011488)Trylon Corp.2002-02-22
CLEARPLANE EASY OVULATION TEST (K013874)Unipath , Ltd.2002-02-19
MB 103 MILLENNIUM BLADES (K011833)Millennium Biomedical, Inc.2002-02-15
MB 102 MILLENNIUM BLADES (K020122)Millennium Biomedical, Inc.2002-02-15
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE (K014284)Formosa Glove Industrial Co., Ltd.2002-02-15
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. (K014036)Medtrade Products , Ltd.2002-02-14
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE (K014285)Formosa Glove Industrial Co., Ltd.2002-02-14
NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE (K020317)Sgmp Co., Ltd.2002-02-14
DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS (K014288)Wrp Specialty Products Sdn. Bhd.2002-02-13
POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES (K013998)Sheen More Ent. Co., Ltd.2002-02-13
BRACE EZE (K020009)Udent, Inc.2002-02-11
BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR (K020284)Taiwan Armada Enterprise Co., Ltd.2002-02-08
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA (K014032)Olympus America, Inc.2002-02-08
OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA (K014015)Olympus America, Inc.2002-02-08
PYLORITEK VP TEST KIT 5140VP (K014038)Serim Research Corp.2002-02-08
TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) (K014120)Diagnostics Biochem Canada, Inc.2002-02-08
GELZONE (K013732)Implantech Associates, Inc.2002-02-07
HANDHELD GAMMA FINDER (HGF) (K013751)Silicon Instruments Gmhb2002-02-06
POWDERFREE LATEX SURGEON'S GLOVES (K013914)Kanam Latex Industries Pvt. , Ltd.2002-02-06
POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES (K014077)Shijiazhuang Great Vision Plastic Products Co., LT2002-02-04
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