FDA 510(k) clearances — page 503

176,542 clearances on record, most recent first.

Clearances — page 503

50,201–50,300 of 176,542

K101630 — POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUEPt. Smartglove Indonesia·Product code LZA·2010-09-07
K101868 — INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000VToshiba America Medical Systems, In.C·Product code OWB·2010-09-07
K101883 — 6F ENGAGE/ENGAGE TR INTRODUCERSt Jude Medical·Product code DYB·2010-09-07
K102273 — MERIT BIPOLAR COAGULATION PROBEMerit Medical Systems, Inc.·Product code KNS·2010-09-07
K102368 — NON-ABLATIVE WRINKLE TREATMENT HANDPIECEEllman Int'L, Inc.·Product code GEI·2010-09-07
K091125 — CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2Verilux·Product code ONE·2010-09-03
K100418 — SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODECovidien·Product code GXY·2010-09-03
K100455 — SPAPLUS ANALYZERThe Binding Site·Product code DBI·2010-09-03
K100718 — AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5Aalto Scientific, Ltd.·Product code JJY·2010-09-03
K101054 — ROMIAPEX MODEL A-15Romidan, Ltd.·Product code LQY·2010-09-03
K101086 — TAPERLOC COMPLETEBiomet, Inc.·Product code KWA·2010-09-03
K101186 — AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAGMedtronic Perfusion Systems·Product code DTP·2010-09-03
K101550 — BIOGRAPH MCT FAMILYSiemens Medical Solutions USA, Inc.·Product code KPS·2010-09-03
K101593 — EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXLExact Medical Manufacturing, Inc.·Product code FYA·2010-09-03
K101799 — POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVEWear Safe (Malaysia) Sdn. Bhd.·Product code LYY·2010-09-03
K101834 — 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM3M Company·Product code DRG·2010-09-03
K102011 — ECLIPSE TREATMENT PLANNING SYSTEMVarian Medical Systems, Inc.·Product code MUJ·2010-09-03
K102107 — OSSTAPLE CHILLBiomedical Ent., Inc.·Product code JDR·2010-09-03
K102211 — CRUISER 18 GUIDEWIREBrivant, Ltd.·Product code DQX·2010-09-03
K091969 — EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)Euroimmun Us, Inc.·Product code NBO·2010-09-02
K092736 — EUROIMMUN ANTI-M2-3E ELISA (IGG)Euroimmun Us, Inc.·Product code DBM·2010-09-02
K093430 — EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.Exactech, Inc.·Product code KWS·2010-09-02
K100243 — QUINTEX CERVICAL PLATING SYSTEMAesculap Implant Systems, LLC·Product code KWQ·2010-09-02
K100795 — JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSINGSmith & Nephew, Inc.·Product code KTT·2010-09-02
K101034 — NIOX MINO MODEL 09-1000Aerocrine AB·Product code MXA·2010-09-02
K101130 — BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASKRespironics, Inc.·Product code MNS·2010-09-02
K101310 — VU APOD INTERVERTEBRAL BODY FUSION DEVICETheken Spine, LLC·Product code OVD·2010-09-02
K101326 — NMI ICNavilyst Medical, Inc.·Product code LJS·2010-09-02
K101567 — SHARPS CONTAINERCixi Leinuo Plastic Co., Ltd.·Product code MMK·2010-09-02
K102178 — EASY TOUCHMhc Medical Products·Product code FMF·2010-09-02
K101506 — LUX1540, LUX1440 & LUX2940 LASER HANDPIECESPalomar Medical Technologies, Inc.·Product code ONG·2010-09-01
K101532 — NESSI OTC SPACERPharmacaribe·Product code NVO·2010-09-01
K101602 — VITAL SIGNS MONITORCriticare Systems, Inc.·Product code MLD·2010-09-01
K101860 — NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFTNovabone Products, LLC·Product code MQV·2010-09-01
K102016 — PRECICONTROL CLINCHEM MULTI 1 AND 2Roche Diagnostics·Product code JJY·2010-09-01
K102020 — VEGA SPAN SPINOUS PROCESS PLATE SYSTEMSpinefrontier, Inc.·Product code KWP·2010-09-01
K102176 — FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10Medtronic Cryocath, LP·Product code DRA·2010-09-01
K091539 — IQ 200 URINE ANALIZER BODY FLUIDS MODULEIris Diagnostics·Product code GKL·2010-08-31
K093689 — 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANSMr Medical Solutions, LLC·Product code MOS·2010-08-31
K100102 — CS-SERIES-FPOmega Medical Imaging, Inc.·Product code OWB·2010-08-31
K100124 — FASTX STERNAL INTRAOSSEOUS DEVICEPyng Medical Corp.·Product code FMI·2010-08-31
K100307 — GELSCAN, MODEL 1206Sebia·Product code CFE·2010-08-31
K100518 — INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054Instrumed International, Inc.·Product code DWP·2010-08-31
K100749 — FREQUENCER MODEL V2XDymedso, Inc.·Product code BYI·2010-08-31
K101070 — EXPEDIUM SPINE SYSTEMMedos International SARL·Product code NKB·2010-08-31
K101226 — AUDIT MICROCV RF/CRP LINEARITY SETAalto Scientific, Ltd.·Product code JJY·2010-08-31
K101339 — ARCHER SUPER STIFF GUIDEWIRESMedtronic, Inc.·Product code DQX·2010-08-31
K101600 — INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODELPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN·Product code DQA·2010-08-31
K101605 — MYLABONE ULTRASOUND SYSTEMEsaote Europe B.V.·Product code IYN·2010-08-31
K101714 — NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMSNobel Biocare AB·Product code NHA·2010-08-31
K101878 — GE LOGIQ P5 MODEL H44662LDGE Healthcare·Product code IYN·2010-08-31
K101950 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930Andon Health Co, Ltd.·Product code DXN·2010-08-31
K102014 — TENS STIMULATOR, MODELS 2800 AND 3000Koalaty Products, Inc.·Product code GZJ·2010-08-31
K102044 — ELECSYS DIGOXIN CALCHECK 5Roche Diagnostics·Product code JJX·2010-08-31
K102155 — MR RADIATION ONCOLOGY OPTIONSGe Medical Systems, LLC·Product code LNH·2010-08-31
K092449 — BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·Product code MHX·2010-08-30
K093725 — CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-CCanada Endoscope Corporation·Product code FAJ·2010-08-30
K100055 — BLOOD PRESSURE METER, MODEL CH-609Citizen Systems Japan Co., Ltd.·Product code DXN·2010-08-30
K100448 — ASCENSION MODULAR TOTAL SHOULDER SYSTEMAscension Orthopedics, Inc.·Product code KWS·2010-08-30
K100998 — 1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1Unilife Medical Solutions Limited·Product code MEG·2010-08-30
K101287 — TEPHAFLEX COMPOSITE MESHTepha, Inc.·Product code OWT·2010-08-30
K101810 — 3DHJD CAMERA SYSTEM MODELVision Systems Group, A Division of Viking Systems·Product code GCJ·2010-08-30
K102169 — CYBERWAND LITHOTRIPTERCybersonics, Inc.·Product code FFK·2010-08-30
K093821 — FS ALIGNERAllesee Orthodontic Appliances·Product code NXC·2010-08-27
K093963 — QUASAR BLUE LIGHT THERAPY SYSTEMSilver Bay, LLC·Product code OLP·2010-08-27
K100141 — 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZASiemens Medical Solutions USA, Inc.·Product code MOS·2010-08-27
K100304 — ST AIA PACK HBA1CTosoh Bioscience, Inc.·Product code LCP·2010-08-27
K100367 — MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229Origio A/S·Product code MQL·2010-08-27
K100622 — BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6Belimed Sauter AG·Product code FLE·2010-08-27
K100635 — ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504Arrow Intl., Inc.·Product code LJS·2010-08-27
K100763 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4Microlife Intellectual Property GmbH·Product code DXN·2010-08-27
K101196 — ACCU-CHEK ULTRFLEX INFUSION SETRoche Diagnostics Corp.·Product code FPA·2010-08-27
K101199 — GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,Maquet Critical Care AB·Product code KNT·2010-08-27
K101330 — MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLEMidwest Reprocessing Center, LLC·Product code JOW·2010-08-27
K101561 — TX1 TISSUE REMOVAL SYSTEMAmerican Optisurgical, Inc.·Product code LFL·2010-08-27
K101633 — NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGHNova Biomedical Corp.·Product code JJY·2010-08-27
K101702 — MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFSMidwest Reprocessing Center, LLC·Product code JOW·2010-08-27
K101832 — BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENTMedical Device Technologies, Inc.·Product code KNW·2010-08-27
K101889 — DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICEPivotal Health Solutions·Product code ITH·2010-08-27
K101892 — HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-Heine Optotechnik GmbH & Co. KG·Product code DXQ·2010-08-27
K102119 — SUR-G GLOV AND MAXITEXTerang Nusa Sdn Bhd·Product code KGO·2010-08-27
K102127 — ENDOTRACHEAL TUBE CHANGERSInstrumentation Industries, Inc.·Product code LNZ·2010-08-27
K102129 — LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITORLevitronix, LLC·Product code DWA·2010-08-27
K102157 — ELECSYS PRECICONTROL MULTIMARKERRoche Diagnostics·Product code JJY·2010-08-27
K082800 — STAR/VENT INTERNAL HEX SCREW IMPLANTPark Dental Research Corp.·Product code DZE·2010-08-26
K093420 — XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)Luminex Molecular Diagnostics, Inc.·Product code NTI·2010-08-26
K093753 — MDPO FRAME SYSTEMMdpo, LLC·Product code KTT·2010-08-26
K100210 — TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, TTrans1 Incorporated·Product code MAX·2010-08-26
K100684 — CELLTRACKS AUTOPREP SYSTEM MODEL:9541Veridex, LLC·Product code GKH·2010-08-26
K100886 — INBONE II TOTAL ANKLE REPLACEMENTWrightmedicaltechnologyinc·Product code HSN·2010-08-26
K101036 — SHIMADZU COLLIMATOR R-20JShimadzu Corp.·Product code IZX·2010-08-26
K101100 — CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec·Product code MAI·2010-08-26
K101485 — ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- EBisco, Inc.·Product code KLE·2010-08-26
K101499 — JOURNEY CR KNEE SYSTEMSmith & Nephew, Inc.·Product code JWH·2010-08-26
K101645 — NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OFLatexx Manufacturing Sdn.Bhd.·Product code LYY·2010-08-26
K102130 — TENZING SYSTEMMazor Surgical Technologies , Ltd.·Product code HAW·2010-08-26
K093175 — WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TESGuangzhou Wondfo Biotech Co., Ltd.·Product code DJG·2010-08-25
K093604 — ETEST MOXIFLOXACIN 0.002-32 UG/MLAb Biomerieux·Product code JWY·2010-08-25
K093847 — DUFLO CATHETER (HEPARIN COATED)Thermopeutix, Inc.·Product code MJN·2010-08-25
K100390 — SURGIMAX/ SURGIMAX PLUSElliquence, LLC·Product code GEI·2010-08-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.