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

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RecordFirmDate
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR (K110972)Ppp Medical and Safety Products Company Limited2011-06-06
BLUE POWDERFREE NITRILE EXAMINATION GLOVE (K102623)Pt. Medisafe Technologies2011-06-06
PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30) (K100895)Dipped Products Limited2011-05-27
FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL (K110641)Fujirebio Diagnostics,Inc.2011-05-27
E3 TORQUE CONTROL MOTOR (K103653)Dentsply International, Inc.2011-05-26
SMART LEISH, MODEL LGM1-050 (K081868)U.S. Army Medical Research Institute of Infectious2011-05-25
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K110155)Tangshan Xiangrui Plastic Products Co., Ltd.2011-05-23
JBAIDS Q FEVER DETECTION KIT (K103207)Idaho Technology, Inc.2011-05-20
CLEARCUT S SAFETY KNIFE (K110166)Alcon Research, Ltd.2011-05-20
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL (K102993)Seppim S.A.S.2011-05-19
RPS ADENO DETECTOR PLUS (K110722)Rapid Pathogen Screening, Inc.2011-05-17
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K110146)Tangshan Kaiyue Glove Co., Ltd.2011-05-13
POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG (K110102)Preventive Care, Inc.2011-05-13
DROPPER A1C DIABETES CONTROL (K103744)Quantimetrix Corp.2011-05-12
ELECSYS PROLACTIN II CALCHECK 5 (K110613)Roche Diagnostics2011-05-12
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED) (K110314)True Glove Factory2011-05-10
DYNACOR LUBRICATION GEL (K103718)Medline Industries, Inc.2011-05-10
ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS (K100263)Seppim S.A.S.2011-05-06
STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING (K111015)Cardinal Health, Inc.2011-05-06
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL (K103364)Diamond Diagnostics, Inc.2011-05-06
INNOVA WHEELCHAIR (K110788)Columbia Medical Manufacturing, LLC2011-05-06
URIC ACID MODEL 3P39 (K102568)Abbott Laboratories2011-05-06
KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT (K102342)Microphage, Inc.2011-05-05
DILON 6800 ACELLA (ACELLA) (K110384)Dilon Technologies, Inc.2011-05-03
PREMIER C. DIFFICILE GDH (K110620)Meridian Bioscience, Inc.2011-05-03
ICON ADULT MANUAL (K110985)Icon Wheelchairs, Inc.2011-05-03
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K103196)Changda Plastic Product Co., Ltd.2011-04-29
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102152)Hebei Tengda Plastic Co., Ltd.2011-04-28
IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) (K103683)Siemens Healthcare Diagnostics2011-04-28
POWDERED VINYL PATIENT EXAMINATION GLOVES (K102151)Hebei Tengda Plastic Co., Ltd.2011-04-27
TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS (K102517)Thunder Tiger Corp.2011-04-27
PROTECTIVE RESTRAINT (K110377)Medi-Tech Intl. Corp.2011-04-25
VENX REVOLUTION (K110355)Venx, LLC2011-04-22
RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR (K102902)Rubbercare Protection Products Sdn Bhd2011-04-22
POSEY BED (K103817)J. T. Posey Co.2011-04-22
SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL (K103770)Syntex Healthcare Products Co., Ltd.2011-04-21
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM (K103602)Medline Industries, Inc.2011-04-21
FDI GLUCOSE CONTROL SOLUTION FOR AVIVA (K110436)Fujirebio Diagnostics,Inc.2011-04-20
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K110338)Zibo Yuechuan Plastic Products Co., Ltd.2011-04-19
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K110219)Wealth on (Jiangsu) Co., Ltd.2011-04-19
NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K110921)Cardinal Health, Inc.2011-04-15
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K102085)Shijiazhuang Glory Plastic Co., Ltd.2011-04-14
AMC-20 PORTABLE DENTAL CART MODEL AMC-20 (K101332)Aseptico, Inc.2011-04-11
DENOVO TEDDY GEL INFANT HEEL WARMER (K103549)Denovo Products, LLC2011-04-08
XPERT C. DIFFICLE/EPI ASSAY (K110203)Cepheid2011-04-07
ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST (K102225)Alcopro, Inc.2011-04-06
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K110185)Tangshan Baojie Glove Co., Ltd.2011-04-04
NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR) (K103670)Innovative Gloves Co;, Ltd.2011-03-31
THERMO SCIENTIFIC MAS R DOA TOTAL (K103656)Microgenics Corporation2011-03-24
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (K101852)Iris International Inc., A Division of Iris Iris I2011-03-23
ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT (K102241)Anthogyr Sas2011-03-23
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM (K103650)Oon Corp. Resources2011-03-23
RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE (K103661)Rubbercare Protection Products Sdn Bhd2011-03-23
CONFIDENT SURGERY SUITE 300, MODEL CSS300 (K101887)Surgiceye GmbH2011-03-22
SYNTHETIC VINYL EXAMINATION GLOVE, POWDER FREE (K110224)Weifang Beihai Color Printing Packagging Co., Ltd.2011-03-18
SENTINELLA 102 (K110601)General Equipment For Medical Imaging, S.A.2011-03-18
LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 (K101792)Linde Gas North America, LLC2011-03-18
PATIENT EXAMINATION GLOVES (K102846)Thai Hua Holding Co., Ltd.2011-03-17
IDS-ISYS IFG-I CONTROL SET (K110412)Immunodiagnostic Systems , Ltd.2011-03-16
SINGLE CANNULA EXTENDED APPLICATOR (K102563)Micromedics, Inc.2011-03-15
ALLERGEAZE R CLEAR (K103409)Smartpractice2011-03-15
OSSPRAY SYLC CR (K103114)Osspray, Ltd.2011-03-14
SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (K102403)Sam Medical Products2011-03-03
NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES (K101820)Yty Industry (Manjung) Sdn Bhd2011-03-03
GENERAL DENISTRY MOTOR (K103399)Aseptico, Inc.2011-02-28
MULTIPLE NAME (K103337)Ideal Quality Sdn., Bhd.2011-02-25
CHALLENGE-EVER (K102223)Hallim Dentech Co., Ltd.2011-02-25
VINYL EXAMINATION GLOVE POWDER FREE (CLEAR, NON-COLRED) /YELLOW/WHITE) (K103772)Advanced Medical Devices Factory2011-02-25
ADAPT, MODEL AX-03SN (K100954)Apeliotus Vision Science, Inc.2011-02-25
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 (K110012)Meridian Bioscience, Inc.2011-02-24
FASTPACK TESTO IMMUNOASSAY (K101388)Qualigen, Inc.2011-02-18
VTS1000 (K101838)Vuetek Scientific, LLC2011-02-18
PATIENT EXAMINATION GLOES (K102840)Thai Hua Holding Co., Ltd.2011-02-18
TECO DIAGNOSTICS UTI DETECTION STRIPS (K100024)Teco Diagnostics2011-02-17
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION (K103553)Bionostics, Inc.2011-02-10
STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER (K103158)Angstrom Mfg., Inc.2011-02-07
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 (K103373)Beckman Coulter, Inc.2011-02-07
PATIENT EXAMINATION GLOVES (K102838)Thai Hua Holding Co., Ltd.2011-02-03
BUTLER CALCI-FLOR PROPHYLAXIS PASTE (K102053)Sunstar Americas, Inc.2011-02-03
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL (K103387)ACON Laboratories, Inc.2011-02-02
SENTICARE PILLSTATION (K103009)Senticare, Inc.2011-01-28
SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA (K102101)Surgivision, Inc.2011-01-26
MSC LIPID CONTROL (K103271)Maine Standards Co.2011-01-25
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE (K103450)Fujirebio Diagnostics,Inc.2011-01-25
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE (K103805)Medical Wire & Equipment Company (Bath), Ltd.2011-01-25
DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE (K103157)Angstrom Mfg., Inc.2011-01-24
ENDOSERTER (K090626)Ocular Systems, Inc.2011-01-21
ELECYSYS SHBG (K102814)Roche Diagnostics2011-01-20
ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (K102743)Ortho Solutions Limited2011-01-20
AUDIT MICROCV PROTEIN LINEARITY SET (K101216)Aalto Scientific, Ltd.2011-01-14
PLATELIA ASPERGILLUS EIA MODEL 62793 (K093678)Bio-Rad2011-01-13
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102613)Hebei Favor Plastic Co., Ltd.2011-01-13
BREATHSCN PRO (K102338)Akers Biosciences, Inc.2011-01-12
AUDIT MICROCV CARDIAC MARKERS LINEARITY SET (K102617)Aalto Scientific, Ltd.2011-01-10
ELECSYS DHEA-S CALCHECK 5 (K103402)Roche Diagnostics2011-01-07
YOBOSHI DENTAL UNIT (K103550)Fosham Yoboshi Medical Equipment Co., Ltd.2011-01-04
ROUGHRIDER (K103212)Whirlwind Wheelchair International2011-01-03
SUPER CHAIR FOR KIDS BY ORION (K103073)Future Mobility Healthcare, Inc.2011-01-03
MODEL LUNA MANUAL WHEELCHAIR (K102910)P.D.G., Inc.2010-12-23
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 (K100715)Aalto Scientific, Ltd.2010-12-23
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