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

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RecordFirmDate
SKIN 2 FORTE SILICONE SHEETING (K990651)United Hospital Technologies, Inc.1999-08-13
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE) (K991950)La Glove (M) Sdn. Bhd.1999-08-12
LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED) (K991949)La Glove (M) Sdn. Bhd.1999-08-12
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI (K991820)Zeus Scientific, Inc.1999-08-12
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K992029)Elan Diagnostics1999-08-12
DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING (K991920)Dermaphylyx, Inc.1999-08-12
MANUAL WHEELCHAIR (K992035)Major Mobility Products, Inc.1999-08-12
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3 (K992550)Bio-Rad1999-08-11
NITRILE EXAMINATION GLOVES POWDER FREE (BLUE) (K991779)Seltom Pacific Sdn. Bhd.1999-08-11
NITRILE EXAMINATION GLOVES POWDER FREE (WHITE) (K991776)Seltom Pacific Sdn. Bhd.1999-08-11
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01 (K991665)A.P. Total Care, Inc.1999-08-10
MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) (K991701)Nsk Nakanishi, Inc.1999-08-10
LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED) (K990883)La Glove (M) Sdn. Bhd.1999-08-10
CARESIDE MG (K991717)Careside, Inc.1999-08-10
IMMUNOCARD STAT! E. COLI O157:H7 (K990263)Meridian Diagnostics, Inc.1999-08-09
SAS ROTA TEST (K990842)Sa Scientific, Inc.1999-08-09
ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE (K992428)Tillotson Healthcare Corp.1999-08-09
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE (K992017)Shanghai Antares Industries, Inc.1999-08-05
PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE. (K991845)Omnigrace , Ltd.1999-08-05
PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE (K991846)Omnigrace , Ltd.1999-08-05
LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K992019)La Glove (M) Sdn. Bhd.1999-08-05
AUTOHDL CHOLESTEROL REAGENT SET (K992002)Pointe Scientific, Inc.,1999-08-05
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR (K991981)Alliance Rubber Products Sdn. Bhd.1999-08-05
SILGEL STC-S (K984029)Nagor , Ltd.1999-08-05
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K973707)Roche Molecular Systems, Inc.1999-08-04
QUICKVUE ONE-STEP H. PYLORI II TEST (K991747)Quidel Corp.1999-08-04
VINYL POWDERED EXAM GLOVE / CAT.# 15-020 (K992289)Vitalcare Group, Inc.1999-08-04
CARESIDE AMMONIA (K991371)Careside, Inc.1999-08-03
INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 (K991867)A.P. Total Care, Inc.1999-08-02
POWDERED LATEX STERILE SURGICAL GLOVES (K992219)Tg Medical Sdn. Bhd.1999-07-30
DERMAPHYLYX FOAM ISLAND DRESSING (K991933)Dermaphylyx, Inc.1999-07-30
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL. (K991968)Smith & Nephew, Inc.1999-07-30
LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS) (K992018)La Glove (M) Sdn. Bhd.1999-07-30
POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE (K991615)Maxxim Medical1999-07-30
SCARAID SILICONE GEL SHEETING (K992146)Biodermis Corp.1999-07-30
BIOTHANE PATIENT RESTRAINT (K991591)Bioplastics1999-07-29
NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE (K992177)Pt. Berlian Glovindo1999-07-29
PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED (K992100)Shanghai Palomar Mountain Industries, Inc.1999-07-29
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992206)Shanghai China Star Corp1999-07-29
CRYOCHECK LA SURE, MODEL SUR25-10 (K990580)Precision Biologic1999-07-28
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED) (K992020)Brightsway Holdings Sdn Bhd1999-07-26
PENTAMIX 2 (K991913)Espe Dental AG1999-07-26
SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE) (K991951)Safeskin Corp.1999-07-26
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE) (K992021)Brightsway Holdings Sdn Bhd1999-07-23
DOCUMENT THYROID CAL*VER (K992034)Casco-Nerl Diagnostics Corporation (Maine)1999-07-23
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES (K992205)Shanghai China Star Corp1999-07-23
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) (K990579)Precision Biologic1999-07-23
EMS SWISS ORTHOCLAST (K991588)(Ems Sa) Electro Medical Systems1999-07-21
CICACARE MANAGEMENT FOR SCARS (K991957)Smith & Nephew, Inc.1999-07-20
DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING (K991609)Dermaphylyx, Inc.1999-07-20
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (K991608)Dermaphylyx, Inc.1999-07-20
TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE (K992122)Maxxim Medical1999-07-15
DYNAREX DRAIN SPONGE (K991694)Dynarex Corp.1999-07-15
DYNAREX NON-WOVEN SPONGE (K991695)Dynarex Corp.1999-07-15
PRO-PORTION CLEANER/DISINFECTANT (K991509)Sultan Chemists, Inc.1999-07-14
REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE (K992151)Consolidated Technologies, Inc.1999-07-14
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K991616)Hartalega Sdn Bhd1999-07-14
ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES (K991992)Allegiance Healthcare Corp.1999-07-13
ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS (K992163)Pdz-Europa , Ltd.1999-07-13
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS (K991733)Schiapparelli Biosystems, Inc.1999-07-13
LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN) (K992031)Shanghai Changzheng Latex Factory1999-07-12
ETI-EA-G ASSAY (K992191)DiaSorin, Inc.1999-07-12
NITRILON CORRECT-TOUCH (K984512)Ct Intl.1999-07-12
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED) (K991940)Brightway Holdings Sdn. Bhd.1999-07-12
OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET (K991917)Metrika, Inc.1999-07-12
POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES (K991624)Smart Glove Corp. Sdn Bhd1999-07-09
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K991789)Elan Holdings, Inc.1999-07-09
SERUM CROSSLAPS ONE STEP ELISA (K990843)Osteometer Biotech A/S1999-07-09
GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K991554)Glovco (M) Sdn. Bhd.1999-07-09
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC (K991849)Seal Polymer Industries Bhd.1999-07-07
SAMSUNG RAYPAX SYSTEM (K991537)Samsung Sds Co., Ltd.1999-07-06
MODIFICATION TO GAMMA GUIDANCE SYSTEM (K983768)Radiation Monitoring Devices, Inc.1999-07-02
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE) (K991939)Brightway Holdings Sdn. Bhd.1999-07-01
NITRILE EXAMINATION GLOVE, POWDERED, BLUE (K991821)Ning BO Yujiang Rubber & Plastic Co.1999-07-01
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE (K991457)Shanghai Palomar Mountain Industries, Inc.1999-07-01
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (K991666)A.P. Total Care, Inc.1999-06-30
DIFOTI SYSTEM (K991098)Electro-Optical Sciences, Inc.1999-06-30
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (K991061)Dermaphylyx, Inc.1999-06-28
SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD (K984508)W&H Dentalwerk Buermoos GmbH1999-06-25
N/T PROTEIN CONTROL LC (K991704)Dade Behring, Inc.1999-06-25
QUANTEC-E IRRIGATION SYSTEM (K991035)Sybron Dental Specialties, Inc.1999-06-24
LATEX EXAMINATION GLOVES (PRE POWDERED) (K991690)Usg Healthguard Sdn Bhd1999-06-24
MTM BIOSCANNER C TEST STRIPS (K990688)Polymer Technology Systems, Inc.1999-06-24
LATEX EXAMINATION GLOVES (POWDER FREE) (K991689)Usg Healthguard Sdn Bhd1999-06-24
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED) (K990876)Brightway Holdings Sdn. Bhd.1999-06-23
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE (K991749)La Glove (M) Sdn. Bhd.1999-06-23
HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K991304)M.R.G. Industries Sdn. Bhd.1999-06-23
ORASCOPE (K991011)Fiberdent Corp.1999-06-23
ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O (K991743)Shield Gloves Manufacturer (M) Sdn Bhd1999-06-23
ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR (K991746)Shield Gloves Manufacturer (M) Sdn Bhd1999-06-23
ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM (K991745)Shield Gloves Manufacturer (M) Sdn Bhd1999-06-23
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN (K991750)Brightsway Holdings Sdn Bhd1999-06-23
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE (K991752)Brightsway Holdings Sdn Bhd1999-06-23
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESSOF WATER EXTRACTABLE PROTEIN PER G (K991748)La Glove (M) Sdn. Bhd.1999-06-23
SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT (K991744)Shield Gloves Manufacturer (M) Sdn Bhd1999-06-23
PRONTO DRY (K991248)Medical Instruments Corporation Mic AG1999-06-22
HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES (K991305)M.R.G. Industries Sdn. Bhd.1999-06-21
NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O (K991742)Yty Industry (Manjung) Sdn Bhd1999-06-21
POWDER FREE VINYL EXAMINATION GLOVES (K983856)Shijiazhuang Brethern Plastic Co., Ltd.1999-06-21
SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES (K990186)Shanghai Intco. Plastic & Rubber Products Co., Ltd.1999-06-21
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