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

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RecordFirmDate
VERACAM (K021083)Lumalite, Inc.2002-08-30
RANDOX LIPID CONTROL (K022591)Randox Laboratories, Ltd.2002-08-30
ACETAL (K022032)Inovativ, LLC2002-08-29
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS (K022491)Cliniqa Corporation2002-08-27
POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL) (K022601)Perusahaan Getah Asas Sdn. Bhd.2002-08-26
POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS) (K022530)Hycare Intl. Co., Ltd.2002-08-26
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (K022538)Diagnostic Chemicals, Ltd. (Usa)2002-08-23
CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR (K022102)Latexx Manufacturing Sdn.Bhd.2002-08-22
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439 (K022707)Bio-Rad2002-08-22
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 (K020226)Hellen Professional Services2002-08-22
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY (K021972)Qualigen, Inc.2002-08-21
PTS PANELS MULTI-CHEMISTRY CONTROLS (K022401)Polymer Technology Systems, Inc.2002-08-21
MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES (K022347)Latexx Manufacturing Sdn.Bhd.2002-08-15
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 (K022529)Bio-Rad2002-08-15
SPIFE LIPPOROTEIN-12, MODEL 3344 (K022333)Helena Laboratories2002-08-15
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 (K022525)Bio-Rad2002-08-15
MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES (K022548)Latexx Manufacturing Sdn.Bhd.2002-08-15
GLOVCO EBONY (K013828)Glovco (M) Sdn. Bhd.2002-08-13
NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR) (K021668)Innovative Gloves Co;, Ltd.2002-08-12
PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS) (K021659)P.T. Healthcare Glovindo2002-08-12
MODIFICATION TO RELIEF BRIEF (K003128)The JM Kohn Co.2002-08-12
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 (K021902)Medtronic Vascular2002-08-12
DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE (K022095)Wilshire Technologies2002-08-09
BOYD DELIVERY UNIT (K020833)Boyd Industries, Inc.2002-08-08
MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE (K022305)Heyuan Hongli Industries, Inc.2002-08-08
TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS) (K021855)Top Glove Sdn. Bhd.2002-08-05
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR (K022101)Latexx Manufacturing Sdn.Bhd.2002-08-02
TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES (K021950)Top Glove Medical (Thailand) Co., Ltd.2002-08-01
CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 (K022232)Cliniqa Corporation2002-08-01
DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE WITH VITAMIN E (K021853)Shanghai Antares Industries, Inc.2002-08-01
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE (K021452)Maxxim Medical2002-08-01
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN) (K022024)Best Manufacturing Company2002-08-01
LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM (K020040)Pt. Maja Agung Latexindo2002-08-01
HYCARE LATEX EXAMINATION GLOVE, POWDER FREE (K020042)Hycare Intl. Co., Ltd.2002-07-30
WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES (K021041)W.A. Rubbermate Co., Ltd.2002-07-30
EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE (K022119)Electro Medical Systems SA2002-07-25
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR (K021316)Genzyme Corp.2002-07-25
J&S MEDICAL SENTRY URINE DIPSTICK CONTROL (K022085)J & S Medical Assoc., Inc.2002-07-25
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) (K021784)Wrp Asia Pacific Sdn. Bhd.2002-07-24
LIGHT CURE DENTAL DAM (K021524)Prime Dental Manufacturing, Inc.2002-07-19
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT (K021671)Jas Diagnostics, Inc.2002-07-19
VIDAS TESTOSTERONE (TES), MODEL 30 418 (K021326)bioMerieux, Inc.2002-07-18
ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL (K021383)Agion Technologies, LLC2002-07-17
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 (K022041)Bio-Rad Laboratories, Inc.2002-07-16
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K021151)Bayer Diagnostics Corp.2002-07-13
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE (K021697)Bionostics, Inc.2002-07-12
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 (K021624)Bionostics, Inc.2002-07-12
MECHANICAL DAILY USE WHEELCHAIR (K021075)First World Services, Inc.2002-07-12
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 (K022053)Sebia2002-07-12
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM (K021927)Biomet, Inc.2002-07-12
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K022087)Shanghai PT Plastics Enterprise Company, Ltd.2002-07-11
ULTRA PRESERVE WITH ALOE VERA (GREEN) NATURAL RUBBER LATEX EXAMINATION GLOVE MADE FROM ALLOTEX AN ENZYME TREATED NATURAL (K021007)Tillotson Healthcare Corp.2002-07-05
POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM (K021119)Wrp Asia Pacific Sdn. Bhd.2002-07-05
GLOVCO BRAND POWDER-FREE NITRILE EXAMINATION GLOVES (PURPLE) (K021730)Glovco (M) Sdn. Bhd.2002-07-05
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS (K020818)Allegiance Healthcare Corp.2002-07-05
FIBIOCORE (K020431)Est. Anthogyr2002-07-03
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM (K021159)Wrp Asia Pacific Sdn. Bhd.2002-07-03
POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE (K021961)Copioumed Intl., Inc.2002-07-02
STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES (K021521)Smart Glove Corp. Sdn Bhd2002-07-02
CARESIDE GGT (K020486)Careside, Inc.2002-07-01
ORS-1000LD (K021288)O.R. Solutions, Inc.2002-06-27
WARMER 2000LD (K021289)O.R. Solutions, Inc.2002-06-26
KAVO QUATTROCARE (K012308)Kavo America2002-06-26
MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL (K021930)Bionostics, Inc.2002-06-25
CHOLESTEROL 1, 2, 3 (K014018)Imi2002-06-24
VISUCAM (K021787)Carl Zeiss Ophthalmic Systems, Inc.2002-06-21
NIVEOUS LIQUID DAM (K021613)Shofu Dental Corp.2002-06-20
HANSATOME EXCELLUS MICROKERATOME (K021640)Bausch & Lomb, Inc.2002-06-19
KARMA 800 SERIES MANUAL WHEELCHAIR (K021866)Vestil Manufacturing Corp.2002-06-14
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C (K021632)Uresil, L.P.2002-06-13
EBV V VCA IGM ELISA KIT MODEL# EBM-200 (K020717)Pan Bio Pty. , Ltd.2002-06-13
EBV-VCA IGG ELISA TEST, MODEL EBG-100 (K020706)Pan Bio Pty. , Ltd.2002-06-13
EBV-EBNA IGG ELISA KIT, MODEL EBG-100 (K020707)Pan Bio Pty. , Ltd.2002-06-13
ORACAM (K020957)Video Dental Concepts, Inc.2002-06-13
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE (K021667)Safehealth Medical Supply Corp.2002-06-11
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O (K021561)Wrp Specialty Products Sdn. Bhd.2002-06-11
COULTER CELLPREP (K021150)Beckman Coulter, Inc.2002-06-11
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 (K021381)Dade Behring, Inc.2002-06-10
CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM (K021388)Seal Polymer Industries Bhd.2002-06-10
ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE (K021598)Eci Medical Technologies, Inc.2002-06-10
DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR (K021536)Wrp Specialty Products Sdn. Bhd.2002-06-10
(MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW (K021743)Copioumed Intl., Inc.2002-06-10
LATEX EXAMINATION GLOVES, POWDER FREE, POLYMER COATED (K021412)Arista Latindo Industrial Ltd. P.T2002-06-07
TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB (K020783)Telesis Technologies, Inc.2002-06-07
SAFE SHIELD PRE-POWDERED LATEX EXAMINATION GLOVES (K013980)Safe Shield Co., Ltd.2002-06-06
POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES (K021506)Shijiazhuang Great Vision Plastic Products Co., LT2002-06-06
NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K021220)Siam Sempermed Corp., Ltd.2002-06-06
STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE (K020943)Shanghai Antares Industries, Inc.2002-06-06
POWDER-FREE-VINYL EXAMINATION GLOVES, COLOR: WHITE (K021353)Glormed Intl., Inc.2002-06-06
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER (K013654)Precision Systems, Inc.2002-06-05
CARESIDE ALT (K020487)Careside, Inc.2002-06-04
PARACON II/FECAL CONCENTRATOR II (K021420)Para Scientific Co.2002-06-04
MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS (K020776)Coronet Group North America, LLC2002-06-03
SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES (K021000)Shanghai Glovmax Enterprise Co.,Ltd2002-05-31
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 (K021414)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 (K021411)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 (K021384)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 (K021415)Bio-Rad2002-05-29
EZ-SCOPE AN & EZ-SCOPE AN LITE (K020643)Health Policy Resorters Group, LLC2002-05-28
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL (K021498)Bio-Rad2002-05-24
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Every clearance here is in the API, with alerts when new ones post.