510(k) Clearances in 2019 — Page 28

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 28 of 59)
510(k) clearancesDetails
K190488 — ProLift Expandable SystemLife Spine, Inc. Jul 23, 2019
K190926 — Hammertoe Truss System (HTS)4Web, Inc. Jul 23, 2019
K191092 — Powder-Free Vinyl Patient Examination Gloves, Yellow ColorAnhui Intco Medical Products Co., Ltd. Jul 22, 2019
K191078 — BAROnova Access Sheath KitBaronova, Inc. Jul 22, 2019
K190834 — Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA Jul 22, 2019
K182985 — Roadrunner PC Wire Guide, Olcott Torque DeviceCook Incorporated Jul 22, 2019
K190975 — Plexus SCD110 Sequential Compression Device SleeveMidway Medical, LLC Jul 22, 2019
K191374 — Revival Modular Hip StemCorin U.S.A. Limited Jul 22, 2019
K191593 — Digital Automatic Blood Pressure Monitor MD36 SeriesGrandway Technology (Shenzhen) Limited Jul 22, 2019
K182817 — CottonDay TamponTaebong Co., Ltd. Jul 22, 2019
K191660 — CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. Jul 20, 2019
K182487 — CerusEndo MicrocatheterCerus Endovascular, Inc. Jul 20, 2019
K182407 — Exceed Microneedling deviceMt. Derm GmbH Jul 19, 2019
K191309 — syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc. Jul 19, 2019
K183349 — AeroDVx SystemSun Scientific, Inc. Jul 19, 2019
K190050 — Tech Dots - Adhesive and conductive gelSpes Medica Srl Jul 19, 2019
K191633 — Infyna ChicHollister Incorporated Jul 19, 2019
K182971 — SpaceOAR Vue HydrogelAugmenix, Inc. Jul 19, 2019
K183545 — Anspach Helix Dissection ToolsThe Anspach Effort, Inc. Jul 19, 2019
K191117 — NvisionVLE Low-profile Optical ProbeNinepoint Medical, Inc. Jul 19, 2019
K191757 — EUROPA Pedicle Screw SystemMiRus, LLC Jul 19, 2019
K191648 — Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation Jul 19, 2019
K182940 — Surdial DX Hemodialysis SystemNipro Medical Corporation Jul 19, 2019
K182798 — KIDScore D3Vitrolife A/S Jul 19, 2019
K190260 — STERIZONE(R) VP4 SterilizerTso3, Inc. Jul 19, 2019
K191467 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0Canon Medical Systems Corporation Jul 19, 2019
K191365 — Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation Jul 19, 2019
K190895 — MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation SystemMedos International SARL Jul 18, 2019
K182794 — BionicGym Powered Muscle StimulatorMedical Currents, Ltd. Jul 18, 2019
K191598 — AOS ES Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc. Jul 18, 2019
K190427 — ImmuciseTerumo Corporation Jul 18, 2019
K183121 — QraypenAIOBIO Co., Ltd. Jul 18, 2019
K182908 — Ziacom Dental Implant SystemsZiacom Medical, S.L. Jul 18, 2019
K191615 — Huvitz Imaging SystemHuvitz Co., Ltd. Jul 18, 2019
K181170 — Trilogy Evo UniversalRespironics, Inc. Jul 18, 2019
K190343 — Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC Jul 18, 2019
K191060 — ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller KitAcist Medical Systems, Inc. Jul 18, 2019
K191370 — DreaMed Advisor ProDreaMed Diabetes, Ltd. Jul 18, 2019
K181166 — Trilogy EvoRespironics, Inc. Jul 18, 2019
K190680 — FAVO S-TLIFSilony Medical GmbH Jul 18, 2019
K191140 — MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc. Jul 18, 2019
K183532 — Latitud Hip Replacement SystemMeril Healthcare Pvt. , Ltd. Jul 18, 2019
K191048 — AcuSnare Polypectomy Snare - DuckbillWilson-Cook Medical, Inc. Jul 18, 2019
K191755 — SPAR-K Instruments (for use with Gemini SL Total Knee System)Waldemar Link GmbH & Co. KG Jul 18, 2019
K190492 — Peralta Stone Removal CatheterCalcula Technologies, Inc. Jul 18, 2019
K182820 — The PODAdvanced Facialdontics, LLC Jul 17, 2019
K191167 — Fungitell STATAssociates Of Cape Cod, Inc. Jul 17, 2019
K191345 — Pegasus SystemA.M. Surgical, Inc. Jul 17, 2019
K191578 — ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality ControlSiemens Healthcare Diagnostics, Inc. Jul 17, 2019
K191711 — ORTHOLOC™ SPS Shoulder Plating SystemTornier, Inc. Jul 17, 2019
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