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

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RecordFirmDate
DISPOSABLE M2-PE MICROKERATOME BLADES (K030401)Oasis Medical, Inc.2003-06-19
C-1805M (K023815)Anodia Systems2003-06-19
CURAD SCAR THERAPY (K024057)Beiersdorf, Inc.2003-06-18
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS (K031231)Bio-Rad2003-06-18
MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G (K031384)Yty Industry (Manjung) Sdn Bhd2003-06-17
ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) (K030528)Clinical Data2003-06-17
SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK (K030891)Surgistar, Inc.2003-06-17
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 (K031101)Hemagen Diagnostics, Inc.2003-06-16
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE (K031021)Perusahaan Getah Asas Sdn. Bhd.2003-06-13
NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS (K030993)Sgmp Co., Ltd.2003-06-12
NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS (K030994)Sgmp Co., Ltd.2003-06-12
POWDERED VINYL EXAM GLOVES, WHITE (K031104)Glormed Intl., Inc.2003-06-10
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST (K024360)Alfa Scientific Designs, Inc.2003-06-10
DISPOSABLE POWDER FREE VINYL EXAM GLOVES (K031113)Elite International, Inc.2003-06-10
MODIFICATION TO CAVERMAP SURGICAL AID (K031527)Blue Torch Medical Technologies2003-06-05
POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM (K030445)Primus Gloves Private , Ltd.2003-06-05
PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES (K030444)Primus Gloves Private , Ltd.2003-06-05
MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 (K031364)Medical Analysis Systems, Inc.2003-05-30
PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER (K023662)Hwadong International Company , Ltd.2003-05-28
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES (K031120)Synmertex Co, Ltd.2003-05-23
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR (K031076)Synmertex Co, Ltd.2003-05-23
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES (K031171)Synmertex Co, Ltd.2003-05-23
DRI COTININE EIA ASSAY (K030649)Microgenics Corp.2003-05-22
FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE (K031020)Pt. Mandiri Inti Buana2003-05-21
DISPOSABLE POWDERED VINYL EXAM GLOVES (K031134)Elite International, Inc.2003-05-20
EVERSTICK POST (K030820)Stick Tech , Ltd.2003-05-20
PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 (K023857)Bio-Rad2003-05-16
COZART EIA COTININE URINE KIT (K021944)Cozart Bioscience , Ltd.2003-05-14
RANDOX AMMONIA (K030873)Randox Laboratories, Ltd.2003-05-12
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE (K031293)Shijiazhuang Eversharp Plastic Products Co., Ltd.2003-05-09
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E (K031072)Shanghai Palomar Mountain Industries, Inc.2003-05-06
KALAZAR DETECT (K023483)Inbios Intl., Inc.2003-05-06
NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 (K030207)Shanghai Motex Healthcare Co., Ltd.2003-05-02
POWDERED VINYL EXAM GLOVES, WHITE (K030997)Heyuan Hongli Industries, Inc.2003-05-02
CHUMP (K030017)Colours 'N Motion2003-05-01
MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL (K030942)Medical Analysis Systems, Inc.2003-04-28
C. DIFFICILE TOX A/B II (K030404)Techlab, Inc.2003-04-24
BABY POD (K030283)Prism Enterprises, Inc.2003-04-22
WORRY-REMOVER IRRIGATOR (K030056)Corisen Group, Ltd.2003-04-22
NOVAVISION, MODEL 2.0 (K023623)Novavision, Inc.2003-04-22
IBD-QUIK CHEK (K030704)Techlab, Inc.2003-04-21
POWDERED VINYL EXAM GLOVES, WHITE (K030927)Copioumed Intl., Inc.2003-04-17
OPHTEC ENCLAVATION NEEDLE (K030471)Ophtec, USA2003-04-17
THERMATREK IRIS-IV INFRARED IMAGING SYSTEM (K030165)Thermatrek2003-04-16
URINE MONOVETTE BORIC ACID (K024237)Sarstedt, Inc.2003-04-14
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS (K030650)Uridynamics, Inc.2003-04-14
PROANGLE DISPOSABLE PROPHY ANGLE (K030603)Pac-Dent International (Suzhou), Ltd.2003-04-14
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A (K030555)Biomet, Inc.2003-04-11
AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) (K030340)Cytomedix2003-04-11
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL (K030801)Bayer Healthcare, LLC2003-04-09
COZART EIA OPIATES ORAL FLUID KIT (K024339)Cozart Bioscience , Ltd.2003-04-07
NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR (K030245)Arista Latindo Industrial Ltd. P.T2003-04-04
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE (K024350)ACON Laboratories, Inc.2003-04-02
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR (K030094)Shanghai Palomar Mountain Industries, Inc.2003-04-01
HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 (K021622)Hill-Rom Air-Shields2003-04-01
CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 (K030616)Microgenics Corp.2003-03-31
POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE (K030386)Shamrock Manufacturing Company2003-03-28
POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM (K030325)Pt.Shamrock Manufacturing Corp.2003-03-28
QUANTA LITE H.PYLORI IGA ELISA (K024334)Inova Diagnostics, Inc.2003-03-27
FIBERFILL SGP (K023819)Pentron Clinical Technologies2003-03-26
LOGOS JUNIOR DENTAL CHAIR AND UNIT (K023513)Castellini S.P.A.2003-03-26
CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL (K030705)Cliniqa Corporation2003-03-26
GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE (K030273)Pt. Wrp Buana Multicorpora2003-03-26
BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS (K024240)Bd2003-03-26
MHS 7000 (K030018)Micro Health Systems, Inc.2003-03-26
LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE (K030134)Pt.Shamrock Manufacturing Corp.2003-03-25
POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE) (K030284)Pt. Smartglove Indonesia2003-03-25
VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E (K023753)Arista Latindo Industrial Ltd. P.T2003-03-25
REACTIVE SKIN DECONTAMINATION LOTION (K023969)Dept. of the Army2003-03-25
VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E (K023754)Arista Latindo Industrial Ltd. P.T2003-03-25
POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE (K030560)Pt.Shamrock Manufacturing Corp.2003-03-21
POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) (K022873)International Biomedical, Inc.2003-03-21
LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM (K030333)Perusahaan Getah Asas Sdn. Bhd.2003-03-21
ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM (K030331)Perusahaan Getah Asas Sdn. Bhd.2003-03-21
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL (K030768)Cliniqa Corporation2003-03-21
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE (K030200)Kaohsiung Brothers Products Corp.2003-03-20
WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 (K030482)Wiener Laboratories2003-03-19
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022096)Bayer Diagnostics Corp.2003-03-18
NEOSPORIN SCAR SOLUTION (K024160)Warner-Lambert Co.2003-03-17
SAS RSV CONTROL KIT (K030628)Sa Scientific, Inc.2003-03-17
MAS LIPID LEVEL 1 AND 2 (K030679)Medical Analysis Systems, Inc.2003-03-14
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES (K030228)Pt. Medisafe Technologies2003-03-14
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS (K030566)Cliniqa Corporation2003-03-13
ATAC PAK MAGNESIUM REAGENT (K030010)Elan Diagnostics2003-03-10
NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN (K030164)Yty Industry (Manjung) Sdn Bhd2003-03-07
ATAC PAK PHOSPHORUS REAGENT (K030015)Elan Diagnostics2003-03-07
SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES (K030483)Emerald Medical, Inc.2003-03-06
SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES (K030484)Emerald Medical, Inc.2003-03-06
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED) (K030075)Best Manufacturing Company-Distribution Center2003-03-05
BAYER LIGAND PLUS 1, 2, 3 CONTROLS (K030452)Bayer Diagnostics Corp.2003-03-03
POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE (K024338)General Gloves Corp.2003-03-03
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 (K030163)Aseptico, Inc.2003-03-03
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED (K030335)Perusahaan Getah Asas Sdn. Bhd.2003-03-03
POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB (K030112)Pt. Smartglove Indonesia2003-02-27
NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR (K030406)Pt. Smartglove Indonesia2003-02-27
TOP GLOVE VINYL EXAMINATION GLOVE (K024216)Top Glove (Zhangjiagang) Co. , Ltd.2003-02-27
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) (K030045)Olympus America, Inc.2003-02-21
XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 (K020595)Xenotope Diagnostics, Inc.2003-02-20
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR (K030148)Shanghai Palomar Mountain Industries, Inc.2003-02-19
MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED) (K022814)Pt. Smartglove Indonesia2003-02-19
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