510(k) Clearances in 2017 — Page 36

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 36 of 64)
510(k) clearancesDetails
K171494 — TroClose1200, TroClose1200 CannulaGordian Surgical, Ltd. Jun 15, 2017
K170499 — sensiLiftEl Global Trade, Ltd. Jun 15, 2017
K170850 — Alma QAlma Lasers , Ltd. Jun 15, 2017
K170992 — AcuNav V 10F Ultrasound CatheterSiemens Medical Solutions USA, Inc. Jun 15, 2017
K170806 — ATTUNE Cemented Tibial Base, Fixed BearingDepuy(Ireland) Jun 15, 2017
K170288 — BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular ShellMicroport Orthopedics, Inc. Jun 15, 2017
K163632 — Katalyst Cyclophotocoagulation ProbeKatalyst Surgical, LLC Jun 15, 2017
K163084 — Merit Coronary Control SyringeMerit Medical Systems, Inc. Jun 15, 2017
K162459 — AccuPoint ElectrodeMicroprobes For Life Science, Inc. Dba Neuron Jun 15, 2017
K162673 — Aptima Herpes Simplex Viruses 1 & 2 AssayHologic, Inc. Jun 15, 2017
K161177 — Axiom PXAnthogyr Sas Jun 15, 2017
K170849 — SIMPLANT GuideDentsply Sirona Jun 15, 2017
K162749 — FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. Jun 15, 2017
K170263 — AcuNav Diagnostic Ultrasound Catheter 8F,10FSiemens Medical Solutions USA, Inc. Jun 15, 2017
K170569 — SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation Jun 15, 2017
K170803 — HydroMARK Breast Biopsy Site MarkersDevicor Medical Products, Inc. Jun 15, 2017
K163467 — C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. Jun 14, 2017
K170457 — EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc. Jun 14, 2017
K170878 — Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC Jun 14, 2017
K163420 — UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc. Jun 14, 2017
K171231 — Endoform Topical MatrixAroa Biosurgery Jun 14, 2017
K170238 — BodyTom EliteNeurologica Corporation, A Subsidiary Of Samsung Electronics Jun 14, 2017
K171484 — hema-screen SPECIFIC GoldImmunostics Inc., Jun 14, 2017
K162719 — iTotal® Hip Replacement SystemConformis, Inc. Jun 14, 2017
K170966 — TONOPORT VIPar Medizintechnik GmbH & Co. KG Jun 14, 2017
K170847 — EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound And Primary Care Diagnostics Jun 14, 2017
K170396 — MAGNETOM VidaSiemens Medical Solutions USA, Inc. Jun 14, 2017
K160890 — Howell Biliary Introducer NeedleWilson-Cook Medical, Inc. Jun 14, 2017
K161216 — Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsImmunalysis Corporation Jun 14, 2017
K170848 — Alzair Allergy BlockerNasaleze International, Ltd. Jun 14, 2017
K161970 — Follicle Aspiration SetVitrolife Sweden AB Jun 14, 2017
K171111 — SculpsureCynosure, Inc. Jun 13, 2017
K171468 — FUSE Spinal SystemMedtronic Sofamor Danek Jun 13, 2017
K160753 — COOK Vacuum PumpWilliam A. Cook Australia Pty. , Ltd. Jun 13, 2017
K170325 — SECRET RFIlooda Co,., Ltd. Jun 13, 2017
K170713 — da Vinci Xi Surgical SystemIntuitive Surgical, Inc. Jun 13, 2017
K171427 — Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc. Jun 13, 2017
K163079 — HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy SystemHealthlight, LLC Jun 13, 2017
K171426 — da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeIntuitive Surgical, Inc. Jun 13, 2017
K163060 — Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd. Jun 13, 2017
K171418 — 1417WCC_127um and1417WCC_140umRayence Co., Ltd. Jun 12, 2017
K161354 — MELODY, Remote Control System for Ultrasound ProbeAdecho Tech Jun 12, 2017
K171509 — Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc. Jun 12, 2017
K171437 — SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. Jun 12, 2017
K162755 — PicocareWontech Co., Ltd. Jun 12, 2017
K171417 — 1417WGC_127um and 1417WGC_140umRayence Co., Ltd. Jun 12, 2017
K162625 — SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon CathetersB. Braun Interventional Systems, Inc. Jun 12, 2017
K162986 — SPIRA Open Matrix ALIFCamber Spine Technologies Jun 12, 2017
K170823 — Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound And Primary Care Diagnostics Jun 12, 2017
K163652 — ePlex InstrumentGenmark Diagnostics, Incorporated Jun 9, 2017
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