FDA 510(k) clearances — page 306

176,542 clearances on record, most recent first.

Clearances — page 306

30,501–30,600 of 176,542

K162915 — Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd.·Product code DXN·2017-02-08
K163173 — Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd.·Product code OHT·2017-02-08
K163703 — VIVIX-S 1417NVieworks Co., Ltd.·Product code MQB·2017-02-08
K153262 — PUREtraceNemo Healthcare BV·Product code OSP·2017-02-07
K161715 — EndyGelEndymed Medical, Ltd.·Product code GYB·2017-02-07
K161980 — Fuselier Intraoral Nighttime Device (FIND)Fuselier Enterprises, LLC·Product code LRK·2017-02-07
K162639 — Proficient Posterior Cervical Spine SystemSpine Wave, Inc.·Product code NKG·2017-02-07
K163169 — Zilver 518TM Biliary Stent; Zilver 635TM Biliary StentCook Ireland, Ltd.·Product code FGE·2017-02-07
K163214 — Unicare System, Unicare ManipulatorClearpath Surgical, Inc.·Product code LKF·2017-02-07
K170072 — Fitmore® Hip StemZimmer GmbH·Product code KWY·2017-02-07
DEN160016 — Variola virus Real-Time PCR AssayCenters For Disease Control and Prevention (CDC)·Product code PRA·2017-02-06
K160934 — UC-CARE NaviGo WorkstationUC-CARE , Ltd.·Product code LLZ·2017-02-06
K162014 — Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)Bluepoint Medical GmbH & Co. KG·Product code DQA·2017-02-06
K162283 — DCM Kyphoplasty SystemDragon Crown Medical Co., Ltd.·Product code NDN·2017-02-06
K162923 — NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE +3 moreHartalega NGC Sdn. Bhd.·Product code LZA·2017-02-06
K162973 — EndoWrist Suction IrrigatorIntuitive Surgical, Inc.·Product code NAY·2017-02-06
K163061 — Altus Spine Cervical Plate SystemAltus Partners, LLC·Product code KWQ·2017-02-06
K163294 — syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.·Product code LLZ·2017-02-06
K170330 — 3M Protemp Cement Temporary Dental Cement3M Company·Product code EMA·2017-02-06
DEN150035 — SEEKER SystemBaebies, Inc.·Product code PQW·2017-02-03
K152432 — ActiPatch(R)Bioelectronics Corporation·Product code PQY·2017-02-03
K161025 — priti multidisc ZrO2 High TranslucentPritidenta GmbH·Product code EIH·2017-02-03
K161056 — Telemetry TransmitterEdan Instruments, Inc.·Product code MHX·2017-02-03
K161258 — NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitInova Diagnostics, Inc.·Product code MOB·2017-02-03
K161901 — TrapLiner catheterVascular Solutions, Inc.·Product code DQY·2017-02-03
K162106 — Micro-current Wrinkle Reduction Facial service, model EP-400Li-Tek Electronic Technology Corporation·Product code NFO·2017-02-03
K162388 — CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)Curaseal, Inc.·Product code FTM·2017-02-03
K162439 — AxSOS 3 Ti; Stryker Plating SystemStryker GmbH·Product code HRS·2017-02-03
K162536 — GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction CordKerr Corporation·Product code MVL·2017-02-03
K162683 — RehaStim 2Hasomed GmbH·Product code GZI·2017-02-03
K163155 — MTM Clear AlignerDentsply Sirona·Product code NXC·2017-02-03
K163452 — PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.·Product code LJS·2017-02-03
K163551 — LenSx Laser SystemAlcon Laboratories, Inc.·Product code OOE·2017-02-03
K160835 — Titan 3WTzora Active Systems , Ltd.·Product code INI·2017-02-02
K161103 — US SA Implant SystemOsstem Implant Co., Ltd.·Product code DZE·2017-02-02
K161552 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company·Product code NGT·2017-02-02
K163123 — Q-Switched Nd:YAG Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co.·Product code GEX·2017-02-02
K163268 — FlexCath Select Steerable Shealth and DilatorMedtronic Cryocath, LP·Product code DYB·2017-02-02
K163428 — HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity·Product code PEK·2017-02-02
K163511 — NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc.·Product code MEG·2017-02-02
K170019 — Aquilion Lightning, TSX-036A/1, V8.4Toshibamedical Systems Corporation·Product code JAK·2017-02-02
K170061 — ProMIS Fixation SystemPremia Spine, Ltd.·Product code NKB·2017-02-02
K161279 — Life Spine Metatarsal Hemi ImplantLife Spine, Inc.·Product code KWD·2017-02-01
K161360 — U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation·Product code JWH·2017-02-01
K161587 — Memodyn StapleAustin & Associates, Inc./Telos Medical Equipment·Product code JDR·2017-02-01
K162144 — iHealth Wireless Blood Pressure MonitorAndon Health Co, Ltd.·Product code DXN·2017-02-01
K162454 — PicoWay Laser SystemSyneron Candela Corporation·Product code GEX·2017-02-01
K162467 — Twin-Pass TorqueVascular Solutions, Inc.·Product code DQY·2017-02-01
K162624 — Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.·Product code MIB·2017-02-01
K162726 — Exactech® Equinoxe® Preserve StemExactech, Inc.·Product code PHX·2017-02-01
K162958 — MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface +3 moreMedtronic, Inc.·Product code DTR·2017-02-01
K163083 — VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL)bioMerieux, Inc.·Product code LON·2017-02-01
K163095 — Lyme B. burgdorferi (IgG) MarStripe TestTrinity Biotech·Product code LSR·2017-02-01
K163440 — Stealth Staple SystemFirst Ray, LLC·Product code JDR·2017-02-01
K160471 — Medline Non-Surgical Isolation Gown-Medline Industries, Inc.·Product code FYC·2017-01-31
K161158 — IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.·Product code CEW·2017-01-31
K161949 — OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.·Product code GEI·2017-01-31
K162055 — Acclarix LX8 Diagnostic Ultrasound SystemEdan Instruments, Inc.·Product code IYN·2017-01-31
K162381 — HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy DrugsHealthy Glove Co., Ltd.·Product code LZA·2017-01-31
K163122 — NobelClinician, DTX Studio implantNobel Biocare AB·Product code LLZ·2017-01-31
K163170 — Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352Capillus, LLC·Product code OAP·2017-01-31
K163210 — Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH·Product code JAA·2017-01-31
K163542 — CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp.·Product code DSP·2017-01-31
K162034 — OBS Electrosurgical Generator (Model: OBS-350A)Baisheng Medical Co., Ltd.·Product code GEI·2017-01-30
K162098 — LED Phototherapy DeviceLi-Tek Electronic Technology Corporation·Product code OLP·2017-01-30
K162390 — ET Hybrid AbutmentHiossen, Inc.·Product code NHA·2017-01-30
K162879 — Elite Expandable Interbody Fusion DeviceSpineology, Inc.·Product code MAX·2017-01-30
K163004 — Radifocus Glidewire Advantage TrackAshitaka Factory of Terumo Coporation·Product code DQX·2017-01-30
K163058 — Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific·Product code ODG·2017-01-30
K161236 — Universa Firm Ureteral Stents and Stent SetsCook Incorporated·Product code FAD·2017-01-27
K161688 — Advanced Gynecological ApplicatorNucletron B.V.·Product code JAQ·2017-01-27
K161767 — Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH·Product code DXJ·2017-01-27
K161967 — FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cmCallisyn Biomedical, Inc.·Product code KRA·2017-01-27
K162088 — Ecomed Disposable Angiographic SyringesEcomed Solutions, LLC·Product code DXT·2017-01-27
K162285 — EBM iDO Viewer 1.2.1Ebm Technologies Incorporated·Product code LLZ·2017-01-27
K162407 — L300 Go SystemBioness, Inc.·Product code GZI·2017-01-27
K162427 — Vado Bi-Directional Steerable SheathKalila Medical, Inc.·Product code DYB·2017-01-27
K162631 — VERIFY STEAM Integrating Indicator - ShortSTERIS Corporation·Product code JOJ·2017-01-27
K162842 — ASAHI PTCA Guide Wire ASAHI SUOH 03Asahi Intecc Co., Ltd.·Product code DQX·2017-01-27
K162909 — CSX-30 Flat Panel DetectorCanon, Inc. Medical Equipment Group·Product code MQB·2017-01-27
K163042 — chromID Strepto B agarbioMerieux, Inc.·Product code PQZ·2017-01-27
K163211 — MAGNETOM Sempra with syngo MR E11SSiemens Medical Solutions USA, Inc.·Product code LNH·2017-01-27
K163280 — RP Lite 760RMego Afek AC , Ltd.·Product code IRP·2017-01-27
K163312 — MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 SoftwareSiemens Medical Solutions USA, Inc.·Product code LNH·2017-01-27
K163324 — nordicBrainExNordicneurolab AS·Product code LLZ·2017-01-27
K163689 — 3M Clear Tray Aligner3M Unitek Corporation·Product code NXC·2017-01-27
K161219 — Zmaxx T SeriesMaxx Digm, Inc.·Product code EIH·2017-01-26
K161303 — dynaMX Compression PlateMx Orthopedics, Corp.·Product code HRS·2017-01-26
K162587 — ROCCIA® ACIFSilony Medical GmbH·Product code ODP·2017-01-26
K162790 — V.A.C.ULTA Negative Pressure Wound Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)·Product code OMP·2017-01-26
K162882 — KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.·Product code OWN·2017-01-26
K163044 — ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc·Product code HRS·2017-01-26
K163179 — Onli Intermittent CatheterHollister Incorporated·Product code GBM·2017-01-26
K163281 — FastStrokeGef Medical Systems Scs·Product code JAK·2017-01-26
K163368 — FITBONE TAAWittenstein Intens GmbH·Product code HSB·2017-01-26
K163574 — Multi Modality ViewerVital Images, Inc.·Product code LLZ·2017-01-26
K163660 — Pantera LEOBiotronik, Inc.·Product code LOX·2017-01-26
K163693 — IntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC·Product code DXC·2017-01-26
K163715 — Allura Xper R9Philips Medical Systems Nederland B.V.·Product code OWB·2017-01-26
K160976 — Altus Spine Interbody Fusion SystemAltus Partners, LLC·Product code MAX·2017-01-25

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