510(k) Clearances in 2017 — Page 39

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 39 of 64)
510(k) clearancesDetails
K171344 — Xenocor Xenoscope Laparoscopic SystemXenocor, Inc. Jun 1, 2017
K170200 — Carbon Dioxide Reagent SetTeco Diagnostics, Inc. Jun 1, 2017
K162954 — OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC Jun 1, 2017
K170652 — ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsFisher Diagnostics Jun 1, 2017
DEN160043 — Sentinel Cerebral Protection SystemClaret Medical, Inc. Jun 1, 2017
K170711 — ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH Jun 1, 2017
K170741 — GTK Disposable Needle GuidesGeotek Medikal Ltd Sti Jun 1, 2017
K170904 — Biograph Horizon PET/CTSiemens Medical Solutions USA, Inc. Jun 1, 2017
K162389 — Medcomp Vessel DilatorMedcomp ( Medical Components) Jun 1, 2017
K162601 — Infusion Set for Single UseShinva Ande Healthcare Apparatus Co., Ltd. May 31, 2017
K170573 — Empowr CR Knee Tibial InsertEncore Medical L.P. May 31, 2017
K171387 — EMS100 Tri-Wave Combination StimulatorElite Medical Supply Of New York, LLC May 31, 2017
K163482 — Orthodontic Acrylic 2Lang Dental Manufacturing Co., Inc. May 31, 2017
K170658 — Lympha Press Optimal PlusMego Afek AC , Ltd. May 31, 2017
K171338 — B R A H M S PCT sensitive KRYPTORBrahms GmbH May 31, 2017
K171268 — Reverse 021 Micro Catheter, Reverse 027 Micro CatheterMicro Therapeutics, Inc. D/B/A Ev3 Neurovascular May 31, 2017
K170698 — ALLY(TM) Bone ScrewsProvidence Medical Technology, Inc. May 31, 2017
K170278 — OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 FastenersC.R. Bard, Inc. May 31, 2017
K171388 — EndoWrist Stapler 45 System and Stapler 45 ReloadsIntuitive Surgical, Inc. May 31, 2017
K170626 — Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand pieceAlma Lasers, Inc. May 31, 2017
K170670 — Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)bioMerieux, Inc. May 31, 2017
K162684 — SL 220Carl Zeiss Meditec, AG May 31, 2017
K170007 — Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. May 31, 2017
K163356 — Pulse* Spray Infusion System, Uni*Fuse Infusion SystemAngioDynamics, Inc. May 30, 2017
K170604 — FilmArray Respiratory Panel 2 (RP2)Biofire Diagnostics, LLC May 30, 2017
K170695 — VenaCure EVLT NeverTouch Direct Introducer SheathAngioDynamics, Inc. May 30, 2017
K162574 — AmCAD-USAmcad Biomed Corporation May 30, 2017
K171314 — QLAB Advanced Quantification SoftwarePhilips Health Care May 30, 2017
K170954 — Portable ECG MonitorContec Medical Systems Co.,Ltd May 30, 2017
K170899 — 27HJ713SLg Electronics May 30, 2017
K163505 — ARIETTA PRECISIONHitachi , Ltd. May 30, 2017
K170521 — TRINITY/3D PROSTATE SUITEKoelis May 30, 2017
K171306 — gammaCore-SElectrocore, LLC May 30, 2017
K163702 — Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation May 30, 2017
K170216 — Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) May 26, 2017
K170692 — Respire Pink Series with DentiTracRespire Medical Holding May 26, 2017
K162526 — Creatine Kinase-MBRoche Diagnostics May 26, 2017
K162603 — Masimo O3 Regional Oximeter SystemMasimo Corporation May 26, 2017
K171296 — SutureTapeArthrex, Inc. May 26, 2017
K171294 — da Vinci X Surgical SystemIntuitive Surgical, Inc. May 26, 2017
K171234 — Mistral-Air Warming UnitThe Surgical Company International BV (As The 37Company) May 26, 2017
K162448 — White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing CatheterCook Incorporated May 26, 2017
K170839 — RAPID WebGiven Imaging , Ltd. May 26, 2017
K170659 — IQ TechnologiesIq Technologies, Inc. May 26, 2017
K170178 — Ultravision Visual Field Clearing SystemAlesi Surgical, Ltd. May 26, 2017
K170133 — FFR V2.5Philips Volcano May 26, 2017
K170093 — AcceleDent OptimaOrthoaccel Technology, Inc. May 26, 2017
K171229 — DELL UP3017 with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. May 26, 2017
K163349 — MIS V3 Conical Connection Dental Implant System­Mis Implants Technologies , Ltd. May 26, 2017
K163065 — T3 SoftwareEtiometry, Inc. May 26, 2017
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