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

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RecordFirmDate
SUR-G GLOV AND MAXITEX (K102119)Terang Nusa Sdn Bhd2010-08-27
NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF (K101645)Latexx Manufacturing Sdn.Bhd.2010-08-26
CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (K100684)Veridex, LLC2010-08-26
TACAMO MANUAL WHEELCHAIR (K101719)Dalton Instrument Corp.2010-08-25
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K101358)Hebei Handform Plastic Products Co., Ltd.2010-08-24
DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING (K101717)Aerobine, Inc.2010-08-20
POWDER - FREE PATIENT EXAMINATION GLOVES (K101565)Zibio Yingjie Medical Products Co., Ltd.2010-08-17
NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE (K100975)Jiangsu Sunshine Plastic Products, Co., Ltd.2010-08-17
POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE (K100978)Jiangsu Sunshine Plastic Products, Co., Ltd.2010-08-12
HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT (K100389)Handpiece Headquarters2010-08-12
ORLOCATE SYSTEM MODEL ORL 100 (K100551)Haldor Advanced Technologies, Ltd.2010-08-12
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE (K100977)Jiangsu Sunshine Plastic Products, Co., Ltd.2010-08-12
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 (K101134)Medicel AG2010-08-09
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE (K101595)Better Care Plastic Technology Cp., Ltd.2010-08-06
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100963)Hebei Shenzichen Plastic & Rubber Products Co., LT2010-08-06
CONTRALCO (K100879)Contralco2010-08-04
SCANDIA-45 GAMMA CAMERA SYSTEM (K101391)Scandia Corporation2010-08-04
FORA CONTROL SOLUTION, TAIDOC CONTROL SOLUTION (K093724)Taidoc Technology Corporation2010-07-29
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K101663)Hebei Excellent Plastic Co., Ltd.2010-07-27
RDT3 HANDPIECE HEAD MODEL RDT3 (K101172)Redent Nova, Ltd.2010-07-27
POWDERED VINYL PATIENT EXAMINATION GLOVES (K101664)Hebei Excellent Plastic Co., Ltd.2010-07-27
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U (K100682)Wallac OY2010-07-23
AUDIT MICROCV PROCALCITONIN LINEARITY (K101434)Aalto Scientific, Ltd.2010-07-22
KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- (K101596)Kimberly-Clark2010-07-21
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K101840)Shijiazhuang Sail Plastic Co., Ltd.2010-07-16
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K101841)Shijiazhuang Sail Plastic Co., Ltd.2010-07-16
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100964)Hebei Shenzichen Plastic & Rubber Products Co., LT2010-07-16
POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE (K101102)Best Putra Gloves Sdn Bhd2010-07-16
POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1 (K101103)Best Putra Gloves Sdn Bhd2010-07-16
RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) (K100611)Riverstone Resources Sdn Bhd2010-07-16
RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) (K100603)Riverstone Resources Sdn Bhd2010-07-16
POWDERED VINYL PATIENT EXAMINATION GLOVES (K101343)Shijiazhuang Star Plastic Co., Ltd.2010-07-16
VIVATRAK (K101109)Wireless Medcare, LLC2010-07-15
YEAST TRAFFIC LIGHT PNA FISH (K093024)Advandx, Inc.2010-07-15
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 (K100818)Meridian Bioscience, Inc.2010-07-09
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL (K100907)Siam Sempermed Corp., Ltd.2010-07-09
BD DIRECTIGEN EZ RSV (K101514)Becton, Dickinson & CO2010-07-09
PROSTHODONTIC SCREWDRIVER , MODEL IA-400 (K100600)W&H Dentalwerk Buermoos GmbH2010-07-09
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K100057)Tangshan Kangyuan Glove Co., Ltd.2010-07-08
NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE (K100979)Jiangsu Sunshine Plastic Products, Co., Ltd.2010-07-02
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) (K101293)Pt. Smartglove Indonesia2010-07-01
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK) (K101132)Hong DI Plastic Products Co., Ltd.2010-07-01
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) (K100059)Tangshan Zhongpu Plastic Products Co., Ltd.2010-07-01
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK) (K101135)Hongze Plastic Technology Co., Ltd.2010-07-01
ZEN CORDLESS PROPHY SYSTEM (K101612)Discus Dental, LLC2010-06-30
NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES (K093516)Summit Glove, Inc.2010-06-29
NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE (K093517)Summit Glove, Inc.2010-06-29
COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN (K100694)Tekmedic (M) Sdn Bhd2010-06-25
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA (K083878)R2 Diagnostics, Inc.2010-06-25
STERN'S S250 NORDAM (K092917)Cefla S.C.2010-06-24
MAC-MOBILE AQUATIC CHAIR (K101217)Rehamed Intl., LLC2010-06-23
POWDER FREE VINYL PATIENT EXAMINATION GLOVE (K101137)Hongze Plastic Technology Co., Ltd.2010-06-22
POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES (K092874)Quality Gallant Sdn. Bhd.2010-06-22
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR) (K093335)La Glove (M) Sdn. Bhd.2010-06-18
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) (K101362)Hebei Handform Plastic Products Co., Ltd.2010-06-17
PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE (K100539)Preventive Technologies, Inc.2010-06-17
POWDERED VINYL PATIENT EXAMINATION GLOVES (K101341)Shijiazhuang Universal Channel Plastic Co., Ltd.2010-06-14
ELECSYS INSULIN CALCHECK 5 (K101075)Roche Diagnostics Corp.2010-06-11
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (K093297)Epocal, Inc.2010-06-09
LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET) (K093193)La Glove (M) Sdn. Bhd.2010-06-08
ORION II (HEAVY DUTY 350 LBS AND 500 LBS) (K101277)Future Mobility Healthcare, Inc.2010-06-04
SYLE SMARTIP (K100833)Osspray, Ltd.2010-06-03
VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED (K093264)Qingdao Lang Hui Import & Export Co., Ltd.2010-05-28
ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 (K092704)Abbott Molecular, Inc.2010-05-28
VATEA ENDONTIC IRRIGATION SYSTEM (K100606)Redent Nova, Ltd.2010-05-28
HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB (K090191)Handylab, Inc.2010-05-27
MAIA, MODEL 1 (K092187)Centervue S.P.A.2010-05-27
MECHANICAL WHEELCHAIR, MODEL DS 202-S (K100824)Suzhou KD Medical2010-05-25
AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 (K100750)Aalto Scientific, Ltd.2010-05-21
POWDER-FREE NITRILE GLOVES, BLACK (K100369)Hl Rubber Industries Sdn Bhd2010-05-20
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100699)Shijiazhuang Star Plastic Co., Ltd.2010-05-20
ROYAL GUARD (K092617)Shun Thai Rubber Gloves Industry Public Co., Ltd.2010-05-20
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100856)Suzhou Shengyuda Plastic Products Co., Ltd.2010-05-19
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100735)Rayu Plastic Products Limited2010-05-18
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100734)Huanfu Plastic Products Limited2010-05-18
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100294)Zibo Yinghao Medical Products Co., Ltd.2010-05-14
HDL CHOLESTEROL (HDLX) ASSAY (K100010)Beckman Coulter, Inc.2010-05-14
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100697)Shijiazhuang Universal Channel Plastic Co., Ltd.2010-05-13
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA (K100211)Shen Wei (Usa), Inc.2010-05-11
CENTRAL VISION ANALYZER MODEL 1000 (K100095)Vimetrics,Llc.2010-05-10
POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR (K092302)Bettercare Plastic Products Co., Ltd.2010-05-05
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K100486)Zibo Yinghao Medical Products Co., Ltd.2010-05-05
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100733)Rayen Safety Products Limited2010-04-30
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE (K093263)Qingdao Lang Hui Import & Export Co., Ltd.2010-04-30
ELECSYS FOLATE III CALCHECK 5 (K094031)Roche Diagnostics2010-04-27
URITEST 50 AND URITEST 500 URINE ANALYZER (K091472)Arj Medical, Inc.2010-04-27
ELECSYS C-PEPTIDE CALCHECK 5 (K100810)Roche Diagnostics2010-04-26
SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER (K092911)Diazyme Laboratories2010-04-26
ERGO IMAGING SYSTEM (K100838)Digirad Corp.2010-04-23
ELECSYS TESTOSTERONE II IMMUNOASSAY (K093421)Roche Diagnostics Corp.2010-04-23
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100855)Suzhou Shengyuda Plastic Products Co., Ltd.2010-04-22
DENTAL HANDPIECE (K093971)North West Medical Instrument (Group) Co., Ltd.2010-04-22
NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT (K092472)Ascend Eagle, Inc.2010-04-15
ELECSYS TSH CALCHECK 5 (K093836)Roche Diagnostics2010-04-15
CONTREX PLUS LOW CONTROL SOLUTION (K100747)Apex BioTechnology Corp.2010-04-14
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K100392)Tangshan Jiaxing Plastic Products Co., LT2010-04-13
MULTI FRAME WHEELCHAIR (K100084)R82 A/S2010-04-12
POWDER-FREE VINYL EXAM GLOVES (K091772)Shijiazhuang Huijingyuan Plastic Co, Ltd.2010-04-08
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K100419)Tangshan Yongkang Glove Co., Ltd.2010-04-06
VINYL PATIENT EXAM GLOVES PRE-POWERED, CLEAR (K091770)Shijiazhuang Huijingyuan Plastic Co, Ltd.2010-04-06
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