510(k) Clearances in 2018 — Page 45

3,062 510(k) clearances total

Browse FDA 510(k) clearances granted in 2018. RegDataLab tracks 3,062 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2018 (page 45 of 62)
510(k) clearancesDetails
DEN170001 — Precision Flow® HVNIVapotherm, Inc. Apr 10, 2018
K180301 — AXIS 5.5 Lumbar Pedicle Screw SystemAxis Orthopaedics Apr 10, 2018
K173384 — BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tubeSmiths Medical Ads, Inc. Apr 10, 2018
K180530 — Imager II Urology Torque CatheterBoston Scientific Corporation Apr 10, 2018
K180233 — Eviva Stereotactic Guided Breast Biopsy SystemHologic, Inc. Apr 10, 2018
K170776 — DTI-1 SLA IMPLANT SYSTEMDti Implant Sistemleri Sanayi Ticaret Anonim Sirketi Apr 10, 2018
K180398 — Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 MultifocalAlcon Laboratories, Inc. Apr 10, 2018
K180299 — ACUVUE OASYS (senofilcon A) with Photochromic AdditiveJohnson & Johnson Vision Care, Inc. Apr 10, 2018
K180372 — Aurora EvacuatorRebound Therapeutics Apr 9, 2018
K171409 — OT EQUATORRhein'83 Srl Apr 9, 2018
K180329 — ClotTriever Thrombectomy SystemInari Medical, Inc. Apr 9, 2018
K173386 — Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy DrugsLucenxia Prescience AG Apr 9, 2018
K180208 — Disposable Endoscopic TrocarFengh Medical Co., Ltd. Apr 9, 2018
K173889 — Medline Cautery Electrode (PTFE)Medline Industries, Inc. Apr 9, 2018
K180083 — Silicone Personal Lubricant, ALL-IN-ONEUnited Consortium Apr 9, 2018
K172151 — Hysteroscopy SystemChongquin Jinshan Science & Technology (Group) Co., Ltd. Apr 9, 2018
K173525 — NovoGroOsteonovus, Inc. Apr 6, 2018
K180614 — PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited Apr 6, 2018
K170570 — Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc. Apr 6, 2018
K180271 — NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc. Apr 6, 2018
K180080 — FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc. Apr 6, 2018
K173767 — A. L. P. S. Clavicle Plating SystemBiomet, Inc. Apr 6, 2018
K180033 — 8mm Monopolar Curved ScissorsIntuitive Surgical, Inc. Apr 6, 2018
K172173 — DiaSpect Tm, DiaSpect Tm CuvettesEkf-Diagnostic GmbH Apr 6, 2018
K180324 — Patriot Spinal Fixation SystemValorus Spine Apr 6, 2018
K173775 — Clench Compression StapleF & A Foundation, LLC D.B.A. Reign Medical Apr 6, 2018
K180630 — PTFE SURGICAL SUTUREOmnia Spa Apr 6, 2018
K180584 — Viveve RF System, SecureViveve, Inc. Apr 6, 2018
K172956 — Medicant Mucosal AtomizerMedica Holdings, LLC Apr 6, 2018
K172998 — uWS-MIShanghai United Imaging Healthcare Co., Ltd. Apr 5, 2018
K172014 — Wedge MicrocatheterMicroVention, Inc. Apr 5, 2018
K180089 — Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A. Apr 5, 2018
K180378 — Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior ModuleOptomed OY Apr 5, 2018
K171847 — Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited Apr 5, 2018
K173586 — VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC Apr 5, 2018
K173526 — SENTIO MMG Gen 2Medos International SARL Apr 5, 2018
K173207 — SIC invent Dental Implant SystemsSic Invent AG Apr 5, 2018
K180349 — AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. Apr 5, 2018
K180589 — DR 800 with MUSICA DynamicAgfa Healthcare N.V. Apr 5, 2018
K171713 — Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A. Apr 5, 2018
K173867 — Axis Anterior Cervical Plate SystemAxis Orthopaedics Apr 5, 2018
K172368 — Bipolar Micro-Coagulation ForcepsGunter Bissinger Medizintechnik GmbH Apr 5, 2018
K173897 — syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc. Apr 5, 2018
K180376 — K2M Patient Specific RodsK2M, Inc. Apr 5, 2018
K172156 — PENTAX Medical EPK-3000 Video Imaging SystemPentax Medical Apr 5, 2018
K180125 — PowerLook Density Assessment SoftwareIcad, Inc. Apr 5, 2018
K173333 — GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. Apr 5, 2018
K180344 — TheraCal DCBisco, Inc. Apr 5, 2018
K180694 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersSpectranetics, Inc. Apr 5, 2018
K162408 — Nano Varnish, Plaquit, Lightpaint on SurfaceDreve Dentamid GmbH Apr 5, 2018
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