510(k) Clearances in 2017 — Page 44

3,200 510(k) clearances total

Browse FDA 510(k) clearances granted in 2017. RegDataLab tracks 3,200 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2017 (page 44 of 64)
510(k) clearancesDetails
K163672 — Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. May 5, 2017
K161770 — Rusch Silicone Foley CatheterTeleflexmedical, Inc. May 5, 2017
K163315 — Internal Distraction - SterileKLS Martin L.P. May 5, 2017
K163615 — Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsCarefusion 2200, Inc. May 4, 2017
K171141 — Arthrex SwiveLock AnchorsArthrex, Inc. May 4, 2017
K162254 — Cedic Enteral ENFit Transition ConnectorsCedic S.R.L. May 4, 2017
K162330 — Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation May 4, 2017
K162496 — Foundation 3D InterbodyCorelink, LLC May 4, 2017
K170543 — VIPER PRIME™ Screws with FenestrationsMedos International SARL May 4, 2017
K163468 — Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredCook Ireland, Ltd. May 4, 2017
K163238 — Eclipse Kiss ZirconiaAms May 4, 2017
K162207 — Restore Moisturizing Vaginal LubricantGood Clean Love May 4, 2017
K171130 — Nucleus Image Management SystemNucleushealth, LLC May 4, 2017
K163683 — A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure MonitorA&D Company, Ltd. May 3, 2017
K163530 — PrisMax Control UnitBaxter Healthcare Corp May 3, 2017
K170269 — Hee HR MiniOriental Inspiration Limited May 3, 2017
K171005 — Silhouette FeatherliftSilhouette Lift, Inc. May 3, 2017
K163481 — HALF DOME Posterior Lumbar Interbody SystemAstura Medical May 3, 2017
K162952 — C.T.M. Mobility ScooterChien TI Enterprise Co., Ltd. May 3, 2017
K162523 — The IQool SystemBraincool AB May 3, 2017
K170107 — Surgi Max UltraElliquence, LLC May 3, 2017
K163640 — QZA and RS Dental Implant SystemsTrinon Titanium GmbH May 3, 2017
K170440 — KISSloc Suture SystemArthrosurface, Inc. May 3, 2017
K170977 — SURESHOT Distal Targeting System V4.0 Trauma InterfaceSmith & Nephew, Inc. May 3, 2017
K170718 — Iridex TruFocus LIO PremiereIridex Corporation May 3, 2017
K162263 — Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd. May 3, 2017
K162756 — PHAKOS Disposable Retinal Cryo ProbePhakos May 3, 2017
K162248 — Asahi ViE-U Series DialyzerAsahi Kasei Medical Co., Ltd. May 3, 2017
K170108 — Xultan 5.5 Pedicle Screw SystemMet One Technologies May 2, 2017
K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup TestAssure Tech. (Hangzhou) Co, Ltd. May 2, 2017
K162380 — Locking Plate SystemBeijing Keyi Medical Device Technology Co., Ltd. May 2, 2017
K170360 — NAVIOBlue Belt Technologies, Inc. May 2, 2017
K170308 — BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson And Company May 2, 2017
K160781 — Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons GlovesSemperit Investments Asia Pte , Ltd. May 2, 2017
K161790 — iGlucose Blood Glucose Monitoring SystemBionime Corporation May 2, 2017
K162041 — Airworks Nebulizer pe1200mConvexity Scientific, LLC May 2, 2017
K170364 — Collagen Meniscus Implant XLIvy Sports Medicine, LLC May 2, 2017
K163621 — Vitoss Bioactive (BA) InjectableOrthovita, Inc. May 2, 2017
K171098 — AXIS Image Management SystemSonomed, Inc. May 2, 2017
K163626 — ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation May 2, 2017
K170141 — Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated May 2, 2017
K162303 — REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc. May 1, 2017
K170733 — ScanX Intraoral ViewDuerr Dental AG May 1, 2017
K170114 — MagVita TMS Therapy - w/MagPro R20Tonica Elektronik A/S May 1, 2017
K170777 — Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation May 1, 2017
K162620 — Remel Spectra ESBLRemel, Inc. May 1, 2017
K170011 — StealthStation S8 Spine Software v1.0.0Medtronic Navigation May 1, 2017
K170294 — VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) OvalC. R. Bard May 1, 2017
K170975 — Televere Digital Imaging SystemTelevere Systems May 1, 2017
K163119 — NaviSuite SSI EditionMedcom GmbH May 1, 2017
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