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

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RecordFirmDate
NITRILE EXAM GLOVE, POWDER FREE (K980677)Ningbo Yujiang Plastic & Rubber Co. , Ltd.1998-03-16
OSMO/PCA PILLOW WOUND DRESSING (K971612)Procyte Corp.1998-03-16
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN) (K980572)Hartalega Sdn Bhd1998-03-13
INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) (K971591)David C. Bishop, Ph.D.1998-03-13
LATEX EXAMINATION GLOVE POWDER FREE (K974870)Smart Glove Corp. Sdn Bhd1998-03-13
ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE (K974670)Athena Technology, Inc.1998-03-13
POWDERFREE BLUE NITRILE EXAMINATION GLOVES (K980285)Besglove Medicare Sdn. Bhd.1998-03-13
NITRILE PRE-POWDERED EXAMINATION GLOVES (K974907)Smart Glove Corp. Sdn Bhd1998-03-13
NITRILE EXAMINATION GLOVES - POWDER FREE (K980511)Influx Pacific Sdn. Bhd.1998-03-13
LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES (K980618)Lovytex Sdn Bhd1998-03-13
LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING (K973664)Evergrade Healthcare Products Sdn Bhd1998-03-13
SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES (K980071)Supermax Latex Products Sdn. Bhd.1998-03-13
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE (K980419)Omnigrace (Thailand) , Ltd.1998-03-13
POWDERFREE LATEX EXAMINATION GLOVES (K980194)Besglove Medicare Sdn. Bhd.1998-03-13
LATEX EXAMINATION GLOVES (K980215)P.T. Wantong Industry1998-03-13
VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (K973628)Vital Scientific N.V.1998-03-13
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED (K980421)Omnigrace (Thailand) , Ltd.1998-03-13
POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED) (K980275)Besglove Medicare Sdn. Bhd.1998-03-13
SMARTTEX (K974557)Smart Glove Corp. Sdn Bhd1998-03-13
POWDERFREE LATEX EXAMINATION GLOVES (K980167)Besglove Medicare Sdn. Bhd.1998-03-13
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) (K980280)Besglove Medicare Sdn. Bhd.1998-03-13
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE) (K980318)Hartalega Sdn Bhd1998-03-11
ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR (K974671)Athena Technology, Inc.1998-03-11
23:1 REDUCTION ANGLE (K973800)Midwest Dental Products Corp.1998-03-11
CREST TOOTHBRUSH WITH MICROSHIELD (K973236)Procter & Gamble Co.1998-03-11
PYLORI DETECT IGG (K973508)Micro Detect, Inc.1998-03-10
NON-WOVEN COMPRESS (K980382)Convatec, A Division of E.R. Squibb & Sons1998-03-09
PERSYST PRISM (K974718)Persyst Development Corp.1998-03-09
CARESIDE ANALYZER (K980056)Exigent Diagnostics, Inc.1998-03-06
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC (K974751)General Hearing Instruments, Inc.1998-03-06
OSTEOMARK (K980518)Ostex Intl., Inc.1998-03-06
MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE (K974354)Sca Molnlycke1998-03-05
CYBERSONIC (K980075)American Dentronics, Inc.1998-03-04
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002 (K980514)Medical Analysis Systems, Inc.1998-03-04
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II (K971522)Abbott Laboratories1998-03-03
ACCUSTAT H. PYLORI ONE STEP TEST (K973523)Boehringer Mannheim Corp.1998-03-03
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K974721)Bayer Corp.1998-03-03
DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE (K980093)Universal Gloves Corp.1998-03-02
FASTDAM (K972775)Interdent, Inc.1998-02-27
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM (K973000)Alimenterics, Inc.1998-02-26
DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS (K980509)Deroyal Industries, Inc.1998-02-26
NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE (K974710)Sinochem Ningbo Latex Gloves Factory1998-02-25
LIQUICHEK CARDIAC MARKERS CONTROL LT (K980556)Bio-Rad1998-02-25
TESTOTERONE ELISA (K973900)Kmi Diagnostics, Inc.1998-02-24
GLENROE CHAIN (K980053)Glenroe Technologies1998-02-24
LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES (K974782)Mexpo Intl., Inc.1998-02-24
URINE SCREENING DEVICE (K972676)Combact Diagnostic Systems , Ltd.1998-02-23
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL (K972904)Casco Standards1998-02-20
FACEPLATE ASSEMBLY (K974219)Finetone Hearing Instruments1998-02-20
NONWOVEN DRESSING (K974823)Convatec, A Division of E.R. Squibb & Sons1998-02-20
MOISTAIR FLUID AIR TUBING SET (K974561)American Medical Devices, Inc.1998-02-19
RUNCH INDUSTRIAL WHEELCHAIR (K980107)Runch Group USA, Inc.1998-02-19
SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 (K974487)Asi Medical, Inc.1998-02-18
ORTHOPLAN (K974406)Ortho-Graphics, Inc.1998-02-18
T.B.Q. RTU (K980369)STERIS Corporation1998-02-17
TRUE VISION, TRUE VISION II (K974542)Medical Dynamics, Inc.1998-02-17
INFUSION DYNAMICS POWER INFUSER (K974074)Infusion Dynamics, Inc.1998-02-17
REGANES RADIONUCLIDE SEED MAGAZINE (K972554)Avid N.I.T., Inc.1998-02-17
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER (K974779)Abbott Laboratories1998-02-13
IISYS PACS SYSTEM (K980220)Sterling Diagnostic Imaging, Inc.1998-02-13
RANDOX MAGNESIUM (K974606)Randox Laboratories, Ltd.1998-02-12
OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY (K980178)Bionostics, Inc.1998-02-12
2700 SAMPLE MANAGER (K980180)Waters Corporation1998-02-12
ABBOTT AXSYM SYSTEM (K974651)Abbott Laboratories1998-02-12
FEMASSIST FLEXIBLE (K974645)Insight Medical Corp.1998-02-12
POWDERFREE LATEX EXAMINATION GLOVES (K974832)Servicom Services Sdn Bhd1998-02-11
BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (K974295)Byron Medical1998-02-10
DENTAL D (K974622)Micro Dental Laboratories1998-02-10
ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL (K974811)Boston Biomedica, Inc.1998-02-10
POWDERED GREEN LATEX EXAMINATION GLOVES (K980039)Sri Johani Sdn. Bhd.1998-02-09
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) (K980037)Sri Johani Sdn. Bhd.1998-02-09
POWDERFREE GREEN LATEX EXAMINATION GLOVES (K980038)Sri Johani Sdn. Bhd.1998-02-09
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST (K973350)Bio-Rad1998-02-09
POWDER-FREE NITRILE EXAMINATION GLOVES (K980150)Masju Sdn. Bhd.1998-02-09
ENCORE MARK IV POWDER FREE SURGICAL GLOVES (K974783)Ansell Perry1998-02-09
ELASTYREN POWDER-FREE SURGICAL GLOVE (K971471)Eci Medical Technologies, Inc.1998-02-09
LATEX (POWDER FREE) LOW PROTEIN (K974853)P.T. Healthcare Glovindo1998-02-09
DIGENE DML 2000 MICROPLATE LUMINOMETER (K980120)Digene Corp.1998-02-06
KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON (K974205)Convatec, A Division of E.R. Squibb & Sons1998-02-06
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER (K973938)Sfri, Inc.1998-02-04
CLEARLINE PLUS, DENTAL WATERLINE FILTER (K973996)Scitech Solutions, Inc.1998-02-04
DENTAL TRAY, STERILE, DISPOSABLE (K974238)Trinity Laboratories, Inc.1998-02-04
LYSONIX IRRIGATION SYSTEM (K974233)Lysonix, Inc.1998-02-03
DBEST ONE-STEP OVULATION TEST (K974508)Ameritek, Inc.1998-02-02
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K980028)Trace America, Inc.1998-02-02
PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 (K974858)Diagnostic Chemicals , Ltd.1998-01-30
NON-PRESCRIPTION SUNGLASSES (K974860)Wenzhou Ming Ming Optical Co. , Ltd.1998-01-30
NON-PRESCRIPTION SUNGLASSES (K974852)Chia Hui Spectacles Mfg. Corp.1998-01-30
VINYL EXAMINATION GLOVES POWDER FREE (K974777)Sun Flower Gloves Co., Ltd.1998-01-30
POWDERED GREEN NITRILE EXAMINATION GLOVES (K974886)Sri Johani Sdn. Bhd.1998-01-30
SURGEON'S GLOVES (K974356)American Health Products, Inc.1998-01-29
POWDERED NITRILE EXAMINATION GLOVES (K980149)Masju Sdn. Bhd.1998-01-29
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (K974887)Sri Johani Sdn. Bhd.1998-01-29
VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE (K974130)Dejarnette Research Systems1998-01-29
ZEROWET SPLASHIELD (K974288)Zerowet, Inc.1998-01-29
BACTEC MYCO/F LYTIC CULTURE VIALS (K970333)Becton Dickinson Microbiology Systems1998-01-28
CARESIDE GLOBULIN (K980055)Exigent Diagnostics, Inc.1998-01-28
QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 (K980135)Radiometer America, Inc.1998-01-28
STAT TRACKS (K974762)Awareness Technology, Inc.1998-01-28
DIAMEDIX IS-MEASLES IGG TEST SYSTEM (K974552)Diamedix Corp.1998-01-28
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