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

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RecordFirmDate
FEIYUE (K140242)Feiyue Glove Co., Ltd.2014-06-12
JIAWANG (K140239)Jiawang Glove Co., Ltd.2014-06-12
MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532) (K123126)Shanghai Motex Healthcare Co., Ltd.2014-06-04
POWDER FREE POLYETHYLENE EXAMINATION GLOVES (K133478)Shijiazhuang Hongzan Plastic Technology Co.,Ltd2014-06-02
NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F (K133123)Yty Industry (Manjung) Sdn Bhd2014-05-30
T1/T2/T3 TURBINE FAMILY (K131319)Sirona Dental Systems GmbH2014-05-30
LMA FAMILY OF AIRWAYS (K130304)The Laryngeal Mask Co., Ltd.2014-05-30
A-DEC/W&H ELECTRIC HANDPIECE MOTOR (K133776)A-Dec, Inc.2014-05-28
VALENTINE STEEL WHEELCHAIR (K130017)Valentine Intl. , Ltd.2014-05-28
RAYSERT PLUS INJECTOR (K141091)Rayner Intraocular Lenses , Ltd.2014-05-28
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M (K133953)Hartalega Sdn Bhd2014-05-28
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN (K133956)Hartalega Sdn Bhd2014-05-28
RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL (K140522)Randox Laboratories Limited2014-05-22
CAPTIA MEASLES IGM (K140455)Trinity Biotech USA2014-05-22
MOTEX POWDERED NITRILE SURGICAL GLOVES (K132802)Shanghai Motex Healthcare Co., Ltd.2014-05-21
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY (K140446)Becton, Dickinson & CO2014-05-20
Y WIRE 2 (K140576)Safewire, LLC2014-05-20
CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR (K133519)Carolina Liquid Chemistries Corp.2014-05-16
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK (K130915)Jas Diagnostics, Inc.2014-05-15
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (K132711)Carolina Liquid Chemistries Corp.2014-05-08
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K122656)Shandong Yifan Plastic Products Co., Ltd.2014-05-06
LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK (K140916)Bio-Rad Laboratories2014-05-06
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR (K132637)Zibo Intco Medical Products Co., Ltd.2014-05-01
IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C (K140818)Siemens Healthcare Diagnostics, Inc.2014-05-01
FAMILY OF DISPOSABLE LENSES (K140368)Sensor Medical Technology, LLC2014-04-29
ELECTRIC HANDPIECE SYSTEM (K132570)Ttbio Corp.2014-04-29
GSP NEONATAL TOTAL GALACTOSE KIT (K133652)Wallac Oy, A Subsidiary of Perkinelmer, Inc.2014-04-28
AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND (K132042)X6d, Ltd.2014-04-28
LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK (K140764)Bio-Rad Laboratories2014-04-25
LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO (K134013)Bio-Rad Laboratories2014-04-24
ERGONOMIC PRODUCTS WORKSTATION (K132315)Ergonomic Products, Inc.2014-04-18
AIR-FLOW HANDY 3.0 (K132478)E.M.S Electro Medical Systems S.A2014-04-11
DECLIPSESPECT LAPAROSCOPY (K133781)Surgiceye GmbH2014-04-11
POWDERED VINYL EXAMINATION GLOVES (K122176)Shu Tong Xinghua Co., Ltd.2014-04-11
POWDER FREE VINYL EXAMINATION GLOVES (K122377)Shu Tong Xinghua Co., Ltd.2014-04-11
MEGA ISQ (K132401)Osstell AB2014-04-09
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS (K133949)Top Calibre Sdn Bhd2014-04-08
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C (K140541)Siemens Healthcare Diagnostics, Inc.2014-04-01
IMBIBE NEEDLE (K140414)Orthovita, Inc.2014-04-01
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL (K140505)Siemens Healthcare Diagnostics, Inc.2014-03-31
QUICK JET M (K133170)Micron Corp.2014-03-28
ELECSYS PRECICONTROL TS (K140534)Roche Diagnostics2014-03-27
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR (K132002)Rayner Intraocular Lenses , Ltd.2014-03-27
WHIP MIX PREPPIES PLUS (K131760)Whip-Mix Corp.2014-03-26
RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 (K140393)Randox Laboratories Limited2014-03-25
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (K132031)Axis-Shield Poc AS2014-03-21
EZ-OX PLUS GENERATION II (K131386)Air Liquide Healthcare America2014-03-14
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) (K140267)Siemens Healthcare Diagnostics, Inc.2014-03-10
IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL (K140258)Siemens Healthcare Diagnostics, Inc.2014-03-05
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130751)Cabin Plastic Co., Ltd.2014-03-05
MOERAE VEIN PREPARATION KIT (K131659)Moerae Matrix, Inc.2014-03-03
EZ TRANSPORT CHAIR (K130517)Harris Medical, LLC2014-02-25
AIR-FLOW HANDY 3.0 PERIO (K132480)E.M.S Electro Medical Systems S.A2014-02-24
ADVIA CENTAUR TESTOSTERONE (TSTO) (K133491)Siemens Healthcare Diagnostics, Inc.2014-02-21
RELIEVA SCOUT SINUS DILATION SYSTEM (K140160)Acclarent, Inc.2014-02-20
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130800)Kaixuan Plastic Co., Ltd.2014-02-18
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130809)Jewel Plastic Co., Ltd.2014-02-18
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (K130891)Friend Plastic Co., Ltd.2014-02-18
MANUAL WHEELCHAIR (K132257)Zhejiang Jiafeng Electrical & Mechanial Co., Ltd.2014-02-13
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K131033)Decent Plastic Co., Ltd.2014-02-12
POWDER FREE LATEX EXAMINATION GLOVES (K123537)Qube Medical Product Sdn Bhd2014-02-12
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130807)Hope Plastic Co., Ltd.2014-02-07
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K131341)Shijiazhuang Winful Plastic Co., Ltd.2014-02-06
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130890)Air Plastic Co., Ltd.2014-02-06
VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT (K133550)Maine Standards Company, LLC2014-02-05
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130582)Heze City Green Food Co., Ltd.2014-02-04
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K132221)Shandong Haoyu Medical Products Co., Ltd.2014-01-31
BREEZY ELEGANCE (K133855)Sunrise Medical (Us), LLC2014-01-31
WONDFO RAPID STREP A TEST (K133343)Guangzhou Wondfo Biotech Co., Ltd.2014-01-31
SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST (K132356)Scican GmbH2014-01-31
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES (K131344)Shijiazhuang Wally Plastics Co., Ltd.2014-01-30
UA-CELLULAR COMPLETE (K131444)Streck2014-01-29
SPIWAY ENDONASAL ACCESS GUIDE (K132721)Spiway, LLC2014-01-29
LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL (K133960)Bio-Rad Laboratories2014-01-22
FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE (K133197)Fujirebio Diagnostics,Inc.2014-01-17
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K130732)Aide Plastic Co., Ltd.2014-01-16
IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL (K132739)Siemens Healthcare Diagnostics, Inc.2014-01-14
REAGENT, RUSSEL VIPER VENOM - LA CONFIRM (K132076)Dsrv, Inc.2014-01-10
REAGENT, RUSSEL VIPER VENOM - LA SCREEN (K132130)Dsrv, Inc.2014-01-10
RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT (K131554)Randox Laboratories, Ltd.2014-01-09
ACTIM PROM (K123986)Alere Scarborough, Inc.2014-01-09
BAUSCH & LOMB INJECTOR SYSTEM (K131958)Bausch & Lomb2014-01-09
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K131832)Shandong Binxiang Medical Products Co., Ltd.2014-01-07
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM (K133146)Bausch & Lomb2014-01-03
EASY-LOAD LENS DELIVERY SYSTEM (K132481)Bausch & Lomb2013-12-27
AMPLIVUE GBS ASSAY (K133503)Quidel Corporation2013-12-20
PATHASSIST LIGHT SEEKER (K133563)Entellus Medical, Inc.2013-12-20
RESTLESS LEG DEVICE (DEN110009)Mary M. Sorg (An Individual) Dba PJ Sleeper'S2013-12-18
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS (K130736)Helix Medical, LLC2013-12-17
SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ (K132688)Biochemical Diagnostics, Inc.2013-12-16
DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE (K132484)Wrp Asia Pacific Sdn. Bhd.2013-12-13
WOUND MEASURING & MONITORING DEVICE (K131596)Woundvision, LLC2013-12-11
VENT-OS SINUS DILATION SYSTEM (K133016)Sinusys Corporation2013-12-09
ALERE BINAXNOW INFLUENZA A & B CARD (K133411)Alere Scarborough, Inc D/B/A Binax, Inc.2013-12-05
CAPELLA (K130788)Future Mobility Healthcare, Inc.2013-12-05
SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR (K132201)Zibo Intco Medical Products Co., Ltd.2013-11-27
POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR (K131828)Jiangsu Handsafe Glove Co., Ltd.2013-11-26
ELECSYS CK-MB CALCHECK 5 (K133284)Roche Diagnostics2013-11-22
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT (K133067)Siemens Healthcare Diagnostics, Inc.2013-11-22
TOPTOUCH /OTHER CLIENTS PRIVATE LABELING (K131826)Jiangsu Toptouch Glove Co., Ltd.2013-11-22
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