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

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RecordFirmDate
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM (K023434)Dorex, Inc.2002-11-14
LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION (K022769)Bionostics, Inc.2002-11-13
ORS-3000LD (K023282)O.R. Solutions, Inc.2002-11-13
MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL (K023153)Ansell Healthcare Products, Inc.2002-11-13
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR (K022784)Syntex Healthcare Products Co., Ltd.2002-11-13
MICROVASIVE PULMONARY GUIDEWIRE (K022059)Boston Scientific Corp2002-11-13
1075LD HUSH-SLUSH (K023283)O.R. Solutions, Inc.2002-11-13
MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE (K023159)Industrial Clothings, Ltd.2002-11-12
SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES (K023236)Maxxim Medical2002-11-12
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES (K023590)Yty Industry (Manjung) Sdn Bhd2002-11-08
NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES (K022572)Ar Alliance Healthcare Sdn. Bhd.2002-11-08
INSTANT-VIEW LH OVULATION PREDICTING TEST (K022829)Alfa Scientific Designs, Inc.2002-11-05
CURAD (K022645)Beiersdorf AG2002-11-05
STEPHENS DISPOSABLE HOOKS (K022842)Stephens Instruments2002-11-01
STEPHENS DISPOSABLE SPECULUM (K022836)Stephens Instruments2002-11-01
STEPHENS DISPOSABLE SCISSORS (K022840)Stephens Instruments2002-11-01
GAYHEART CORNEAL EXCISION DEVICE (K022843)Stephens Instruments2002-11-01
STEPHENS DISPOSABLE FORCEPS (K022835)Stephens Instruments2002-11-01
SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM (K020689)Midi, Inc.2002-10-31
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL (K023307)Medical Analysis Systems, Inc.2002-10-31
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS) (K023262)Perusahaan Getah Asas Sdn. Bhd.2002-10-28
ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED (K023343)Shanghai Palomar Mountain Industries, Inc.2002-10-28
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY (K022356)Nichols Institute Diagnostics2002-10-25
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES (K022604)Sun Flower Gloves Co., Ltd.2002-10-25
VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE (K023428)Shanghai Jiawang Industrial Co. , Ltd.2002-10-25
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM (K022217)Aseptico, Inc.2002-10-24
MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100 (K022535)Microtech2002-10-22
LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K022987)Arista Latindo Industrial Ltd. P.T2002-10-21
CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES (K022346)Latexx Manufacturing Sdn.Bhd.2002-10-18
NICALERT (K021688)Nymox Pharmaceutical Corporation2002-10-18
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K023249)Alcon Laboratories, Inc.2002-10-18
BD K-4000 MICROKERATOME SYSTEM (K023092)Becton, Dickinson & CO2002-10-18
AQUILLA MODULAR WHEELCHAIR (K023005)Haywood Vocational Opportunities2002-10-18
MULTIPLE PRIVATE LABELS VINYL EXAMINATION GLOVES, POWDER-FREE (K023235)Shandong Jiazhan Plastic Products Co., Ltd.2002-10-18
SAS STREPALERT (K023270)Sa Scientific, Inc.2002-10-17
SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR) (K022924)Otto Back Healthcare, LP2002-10-17
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE (K023250)Cliniqa Corporation2002-10-17
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME (K022637)Becton, Dickinson & CO2002-10-16
OLEEVA FABRIC (K023136)Bio Med Sciences, Inc.2002-10-16
POLYMER COATED POWDERFREE LATEX EXAMINATION GLOVE (K022016)Top Glove Medical (Thailand) Co., Ltd.2002-10-15
POWDER-FREE LATEX EXAMINATION GLOVE (GREEN) WITH NATURAL WATER SOLUBLE VITAMIN E AND PROTEIN CONTENT LABELING (50 MICRO (K022566)Qingdao Bestex Rubber & Plastic Products Co., Ltd.2002-10-15
VINYL EXAMINATION GLOVES, PRE-POWDERED (K023145)Shandong Jiazhan Plastic Products Co., Ltd.2002-10-11
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD (K022336)Tangshan Zhonghong Pulin Group Co., Ltd.2002-10-11
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB (K022716)Med-Logics, Inc.2002-10-11
NITRILE POWDER-FREE EXAMINATION GLOVES (K022765)Allegiance Healthcare Corp.2002-10-11
AART SILICONE TUBING (K022306)Aesthetic and Reconstructive Technologies, Inc.2002-10-10
MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (K022238)Medtronic Vascular2002-10-09
EZ-SCOPE AN, EZ-SCOPE LIGHT (K022342)Anzai Medical Co., Ltd.2002-10-09
REPROCESSED DISPOSABLE TROCARS (K022743)Medical Device Services2002-10-09
NITRILE POWDER-FREE EXAMINATION GLOVES (K023170)Allegiance Healthcare Corp.2002-10-09
MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE (K022781)Industrial Clothings, Ltd.2002-10-08
CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS (K022373)Cantor & Nissel , Ltd.2002-10-07
DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE (K022904)Wrp Asia Pacific Sdn. Bhd.2002-10-03
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) (K022808)Wrp Specialty Products Sdn. Bhd.2002-10-03
DISPOSABLE N-PE MICROKERATOME BLADES (K022205)Oasis Medical, Inc.2002-10-03
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE (K022867)Cliniqa Corporation2002-10-02
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE (K022936)Cliniqa Corporation2002-10-02
CLEAN 'N' OIL (K022264)Svenska Dental Instruments AB2002-10-02
LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE (K022885)Cliniqa Corporation2002-10-02
CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (K022512)Immunicon Corp.2002-09-30
LDL CHOLESTEROL (AUTOMATED) (K022519)Jas Diagnostics, Inc.2002-09-30
EBV EA-D IGG ELISA KIT, MODEL EBG-100 (K021793)Pan Bio Pty. , Ltd.2002-09-27
PH AND AMINES EXTERNAL CONTROL SET (K022851)Quidel Corp.2002-09-27
M2 SINGLE USE MICROKERTOME (K022560)Moria SA2002-09-27
PULPDENT PUTTY DAM (K022522)Pulpdent Corporation2002-09-26
CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE CHLORINATED) (K022792)Seal Polymer Industries Bhd.2002-09-26
ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES (BLUE) (K022659)Purna Bina Sdn Bhd2002-09-25
PTS PANELS LIPID PANEL TEST STRIPS (K022898)Polymer Technology Systems, Inc.2002-09-24
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR (K022220)Shen Wei (Usa), Inc.2002-09-23
FERTILITE OV (K020808)Pheromone Sciences Corp.2002-09-23
CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 (K022725)Good Biotech Corp.2002-09-23
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K022744)Medical Device Services2002-09-18
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT (K022772)Hemagen Diagnostics, Inc.2002-09-17
POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA (K022444)Wrp Asia Pacific Sdn. Bhd.2002-09-17
GEN-PROBE APTIMA COMBO 2 ASSAY (K022874)Gen-Probe, Inc.2002-09-17
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 (K022991)Bio-Rad2002-09-17
BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE) (K022878)Brightway Holdings Sdn. Bhd.2002-09-17
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER (K022758)Cliniqa Corporation2002-09-17
MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR (K022818)Smart Glove Corp. Sdn Bhd2002-09-17
POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E (K022701)Perusahaan Getah Asas Sdn. Bhd.2002-09-17
POWDERED SYNTHETIC VINYL EXAM GLOVES (K022702)Shijiazhuang Holy Plastics Co., Ltd.2002-09-16
SYNTHETIC POWDER FREE VINYL PATIENT EXAM GLOVES (K022639)Shijiazhuang Holy Plastics Co., Ltd.2002-09-16
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES (K022600)Shijiazhuang Wally Plastics Co., Ltd.2002-09-16
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS) (K022343)Pt. Wrp Buana Multicorpora2002-09-16
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK (K021687)Binax, Inc.2002-09-13
TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR (K022699)Forever Young Ent. Co., Ltd.2002-09-13
RSV OIA (K021172)Thermo Biostar, Inc.2002-09-13
COMFY HIGH RISER WHEELCHAIR (K022617)Lenjoy Medical Engineering, Inc.2002-09-13
DELUXE MANUAL WHEELCHAIR HW 4000 (K022700)Forever Young Ent. Co., Ltd.2002-09-13
MANUAL WHEELCHAIR (K022825)Major Mobility Products, Inc.2002-09-13
CONVOY ADVANCED DELIVERY SHEATH (K022067)Boston Scientific2002-09-11
POWDER FREE NITRILE EXAMINATION GLOVES (K022619)Ar Alliance Healthcare Sdn. Bhd.2002-09-06
POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS) (K022442)Wrp Asia Pacific Sdn. Bhd.2002-09-05
DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E (K022368)Canopus Medical Supply Co., Ltd.2002-09-05
PICCOLO PHOSPHORUS TEST SYSTEM (K022312)Abaxis, Inc.2002-09-05
SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE (K022092)Syntex Healthcare Products Co., Ltd.2002-09-03
SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE (K022146)Syntex Healthcare Products Co., Ltd.2002-09-03
EYEFEEL OPHTHALMIC WARMER (K021843)Bio-Lipid, Inc.2002-09-03
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE (K022088)Syntex Healthcare Products Co., Ltd.2002-09-03
SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE (K022090)Syntex Healthcare Products Co., Ltd.2002-09-03
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Every clearance here is in the API, with alerts when new ones post.