FDA 510(k) clearances — page 317

176,542 clearances on record, most recent first.

Clearances — page 317

31,601–31,700 of 176,542

K151090 — CPL Insulin Pen NeedleCpl Co., Ltd.·Product code FMI·2016-09-21
K160207 — ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.·Product code NHA·2016-09-21
K160413 — Sterling 5W Diode LaserCAO Group, Inc.·Product code GEX·2016-09-21
K160816 — Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd.·Product code FLL·2016-09-21
K161151 — Spinal fixation systemCanwell Medical Co., Ltd.·Product code MNH·2016-09-21
K161439 — E-CUBE 11Alpinion Medical Systems Co., Ltd.·Product code IYN·2016-09-21
K161591 — QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.·Product code NKG·2016-09-21
K161746 — ARIX Hand SystemJeil Medical Corporation·Product code HRS·2016-09-21
K161843 — Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation·Product code IYN·2016-09-21
K161879 — Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular·Product code NRY·2016-09-21
K162016 — Affinity NT Oxygenator with Cortiva BioActive SurfaceMedtronic, Inc.·Product code DTZ·2016-09-21
K162112 — CAAS MRVPie Medical Imaging BV·Product code LLZ·2016-09-21
K162264 — Cascadia Interbody SystemK2m, Inc.·Product code MAX·2016-09-21
K162338 — Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.·Product code DXN·2016-09-21
K162339 — SceniumSiemens Medical Solutions USA, Inc.·Product code LLZ·2016-09-21
K162345 — UroLift System UL500, UroLift Delivery Handle, UroLift Implant CartiridgeNeotract, Inc.·Product code PEW·2016-09-21
K162359 — Surefire Guiding CatheterSurefire Medical, Inc.·Product code DQY·2016-09-21
K162411 — da Vinci Xi 12 8 mm ReducerIntuitive Surgical, Inc.·Product code NAY·2016-09-21
K153505 — F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited·Product code BZD·2016-09-20
K160919 — Hansen Medical Magellan Robotic Catheter 9FrHansen Medical, Inc.·Product code DRA·2016-09-20
K161086 — Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)Sterilmed, Inc.·Product code NUJ·2016-09-20
K161344 — GentleCath Glide Intermittent CatheterConvatec Limited·Product code KOD·2016-09-20
K161455 — Catalys Precision Laser SystemOptimedica Corporation·Product code OOE·2016-09-20
K161717 — Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.·Product code GYD·2016-09-20
K161721 — Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories·Product code CDD·2016-09-20
K161792 — PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.·Product code GCJ·2016-09-20
K161887 — Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-TipVolcano Corporation·Product code DQX·2016-09-20
K162306 — SomnoDent ALPHASomnomed, Inc.·Product code LRK·2016-09-20
K160862 — AirStrip RPMAirstrip Technologies, Inc.·Product code MSX·2016-09-19
K161262 — Super Distal Access (SDA)Inneuroco, Inc.·Product code DQY·2016-09-19
K161625 — PixelShineAlgomedica·Product code LLZ·2016-09-19
K162497 — 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation·Product code PGY·2016-09-19
K161940 — Guidewire 0.6 Single UseFiagon GmbH·Product code PGW·2016-09-18
K161112 — KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc.·Product code GWG·2016-09-17
DEN150056 — Acclarent Aera Eustachian Tube Balloon Dilation SystemAcclarent, Inc.·Product code PNZ·2016-09-16
K153654 — Sentry WEB SmartInterpCarefusion Germany 234 GmbH·Product code DQK·2016-09-16
K153733 — VORTRAN ManometerVortran Medical Technology 1, Inc.·Product code CAP·2016-09-16
K160262 — n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG·Product code EIH·2016-09-16
K160728 — NutraStim Hair Laser HelmetNutra Luxe MD, LLC·Product code OAP·2016-09-16
K160735 — CATSmartFresenius Kabi AG·Product code CAC·2016-09-16
K160964 — Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.·Product code NHA·2016-09-16
K161162 — Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys UltraEllipse A/S·Product code GEX·2016-09-16
K161489 — Syntorr K-wire and Pin SystemSyntorr, Inc.·Product code HTY·2016-09-16
K161568 — Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.·Product code FMF·2016-09-16
K161804 — LigaSure Retractable L-Hook Laparoscopic Sealer/DividerCovidien·Product code GEI·2016-09-16
K161946 — DoseCHECKSun Nuclear Corporation·Product code IYE·2016-09-16
K162008 — JiveXVisus Technology Transfer GmbH·Product code LLZ·2016-09-16
K162079 — TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc.·Product code MOS·2016-09-16
K162475 — mi-eye 2, mi-eye 2 monitorTrice Medical·Product code HRX·2016-09-16
K151962 — KBL Sunlamp Products (= Device Bundling name)Kbl AG·Product code LEJ·2016-09-15
K152023 — Luminesse Shaded Zirconia SZTalladium, Inc.·Product code EIH·2016-09-15
K152946 — TEMPEDYSeiratherm GmbH·Product code NCX·2016-09-15
K153665 — PROW FUSION-LNlt Spine, Ltd.·Product code MAX·2016-09-15
K160255 — HBOTC Muscle and Nerve StimulatorHb Medical, Inc.·Product code NUH·2016-09-15
K160529 — Pledgeted COR-SUTURE QUICK LOADLsi Soultions·Product code GAW·2016-09-15
K160828 — Dentium Implantium & SuperLine ProstheticsDentium Co., Ltd.·Product code NHA·2016-09-15
K161067 — Mirragen Advanced Wound Matrix, 4x4, Mirragen Advanced Wound Matrix, 2x2, Mirragen Advanced Wound Matrix, 1x6Engineered Tissue Solutions, LLC·Product code QSZ·2016-09-15
K161294 — Compound W Wart Removal System Dual PowerMedtech Products, Inc.·Product code GEH·2016-09-15
K161630 — Provicol QM PlusVoco GmbH·Product code EMB·2016-09-15
K162012 — CARESCAPE Central Station V2GE Healthcare·Product code DXJ·2016-09-15
K162013 — Eusol-CAl.Chi.Mi.A. S.R.L·Product code LYX·2016-09-15
K162047 — LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coatedCovidien·Product code GEI·2016-09-15
K162053 — PhotonBladeInvuity, Inc.·Product code GEI·2016-09-15
K162110 — CORGRIP NG/NI Tube Retention SystemCorpak Medsystems, Inc. A Division of Haylard Health·Product code KNT·2016-09-15
K153311 — Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical)·Product code PPS·2016-09-14
K153660 — StealthStation System with Cranial SoftwareMedtronic Navigation, Inc.·Product code HAW·2016-09-14
K153676 — OSTEON IIIGenoss Co., Ltd.·Product code LYC·2016-09-14
K153723 — ACTICOAT Surgical DressingSmith & Nephew Medical Limited·Product code FRO·2016-09-14
K160341 — Colposcope SystemXuzhou Kernel Medical Equipment Co., Ltd.·Product code HEX·2016-09-14
K160784 — CAM Titanium BlanksAltatec GmbH·Product code NHA·2016-09-14
K161081 — SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation·Product code OVE·2016-09-14
K161384 — Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector CableShockwave Medical, Inc.·Product code PPN·2016-09-14
K161658 — Anexa Wound Flush, Sterile Water & Sterile Normal SalineAnexa Biomedical, Inc.·Product code FRO·2016-09-14
K161818 — GEM Premier 3000Instrumentation Laboratory CO·Product code CGA·2016-09-14
K162172 — EBit Series Diagnostic Ultrasound SystemChison Medical Imaging Co., Ltd.·Product code IYN·2016-09-14
K162177 — dS FootAnkle I6CH 1.5T CoilInvivo Corporation·Product code MOS·2016-09-14
K162195 — TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.·Product code OLO·2016-09-14
K162329 — CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemPhilips Health Care·Product code IYN·2016-09-14
K153130 — Initial LiSi BlockGC America, Inc.·Product code EIH·2016-09-13
K153771 — TXM Guiding SheathTexasmedical Technologies, Inc.·Product code DYB·2016-09-13
K161263 — OptoMonitor IIOpsens, Inc.·Product code DXO·2016-09-13
K161551 — TR-100BTL Industries, Inc.·Product code PBX·2016-09-13
K160221 — Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.·Product code DZE·2016-09-12
K160867 — Pavati Z40.2 ZirconiaCcri, Inc.·Product code EIH·2016-09-12
K161043 — Profound SystemSyneron Candela Corporation·Product code PBX·2016-09-12
K161888 — JULIET® LL Lateral Lumbar CageSpineart·Product code MAX·2016-09-12
K161519 — NeuroStar TMS Therapy SystemNeuronetics, Inc.·Product code OBP·2016-09-11
K151839 — AMC Health VitalCaregiving SystemAmc Health·Product code MWI·2016-09-09
K152879 — Sure-Fine Insulin SyringesShina Med Corporation·Product code FMF·2016-09-09
K153636 — Liberator Powered Wheelchair with Solar CompanionSolar Mobilityllc·Product code ITI·2016-09-09
K153701 — ULYSS Multi View SinuscopeSopro-Comeg GmbH·Product code EOB·2016-09-09
K160117 — AbClose - Port Site Closure DeviceMedeon Biodesign, Inc.·Product code OCW·2016-09-09
K160554 — Enseal X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC·Product code GEI·2016-09-09
K160754 — Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc.·Product code GEI·2016-09-09
K160822 — S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd.·Product code BZD·2016-09-09
K161004 — Self-retaining RetractorFetzer Medical GmbH & Co. KG·Product code GZT·2016-09-09
K161051 — All-Bond Universal w/BAC (not finalized)Bisco, Inc.·Product code KLE·2016-09-09
K161187 — EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy DrugsEco Medi Glove Sdn. Bhd.·Product code LZA·2016-09-09
K161201 — ClearRead CTRiverain Technologies, LLC·Product code OEB·2016-09-09
K161356 — Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd·Product code GEX·2016-09-09

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