510(k) Clearances in 2018 — Page 47

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 47 of 62)
510(k) clearancesDetails
K172335 — Bleep DreamPortSnapcpap Mar 30, 2018
K172078 — ImmuLisa Enhanced RNA POL III Antibody ELISAImmco Diagnostics, Inc. Mar 30, 2018
K170608 — UF(II) Implant SystemDio Corporation Mar 30, 2018
K173637 — syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc. Mar 30, 2018
K171867 — Dr’s Finder NEOGood Doctors Co., Ltd. Mar 30, 2018
K180323 — Vitrea Software Package; VSTP-001ACanon Medical Systems Corporation Mar 30, 2018
K180592 — G-scan BrioEsaote, S.P.A. Mar 30, 2018
K180535 — Voluson P6 and Voluson P8GE Healthcare Mar 29, 2018
K171841 — Arthrex Shoulder SystemArthrex, Inc. Mar 29, 2018
K173082 — Arco™-SA Lumbar Cage SystemNeurostructures, Inc. Mar 29, 2018
K173057 — Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. Mar 29, 2018
K180531 — NovoStitch Pro Meniscal Repair SystemCeterix Orthopaedics, Inc. Mar 29, 2018
K180517 — CorPath GRX SystemCorindus, Inc. Mar 29, 2018
K172843 — TwitchView SystemBlink Device Corporation Mar 29, 2018
K173439 — Bloom2 Programmable Electrophysiology StimulatorFischer Medical Mar 29, 2018
K172071 — Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)Terumo Cardiovascular Systems Corporation Mar 29, 2018
K172322 — Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. Mar 29, 2018
K171624 — IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH Mar 29, 2018
K172298 — OLYMPUS URF-P6/P6ROlympus Medical Systems Corp. Mar 29, 2018
K173799 — NaviCross 0.018Terumo Corporation Mar 29, 2018
K173533 — Duette 100% Silicone Dual-Balloon, Temperature-Sensing CatheterPoiesis Medical, LLC Mar 29, 2018
K171969 — Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction BasketWilson-Cook Medical, Inc. Mar 28, 2018
K180558 — PressureWire XSt. Jude Medical (Now Part Of Abbott Medical) Mar 28, 2018
K172444 — ROSA BRAIN (v3.0.0.5)Medtech S.A Mar 28, 2018
K172627 — David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteRunbio Biotech Co.,Ltd Mar 28, 2018
K173727 — Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView MonitorAmbu A/S Mar 28, 2018
K172235 — CoreHip® SystemAesculap Implants Systems, LLC Mar 28, 2018
K180056 — Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine Mar 28, 2018
K180504 — Mission Lipid Panel Monitoring SystemACON Laboratories, Inc. Mar 28, 2018
K173591 — Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd. Mar 28, 2018
K173489 — GYN-Pump PH304W.O.M. World Of Medicine GmbH Mar 28, 2018
K173465 — Concentrix MX-AC High-Speed HandpieceDentalez, Inc. Mar 28, 2018
K180308 — PreludeMedcom GmbH Mar 27, 2018
K180114 — AEON Retrieval BagLexington Medical, Inc. Mar 27, 2018
K180537 — Zavation Buttress Plate SystemZavation Medical Products, LLC Mar 27, 2018
K173660 — LenSx Laser SystemAlcon Laboratories, Inc. Mar 27, 2018
K180319 — Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning SolutionBausch And Lomb, Incorporated Mar 27, 2018
K171966 — Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A. Mar 27, 2018
K170605 — Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670DJiangsu Yuyue Medical Equipment & Supply Co., Ltd. Mar 27, 2018
K171241 — Pulse OximeterHunan Accurate Bio-Medical Technology Co., Ltd. Mar 27, 2018
K180063 — OCM-G1 AttachmentThe Anspach Effort, Inc. Mar 27, 2018
K173214 — NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes) Mar 27, 2018
K172269 — FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw SystemGlobus Medical, Inc. Mar 27, 2018
DEN170088 — Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. Mar 27, 2018
K180149 — Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion GuideCovidien, LLC Mar 26, 2018
K172760 — REST EAZY ApplianceInsert Molding Solutions, Inc. Mar 26, 2018
DEN170023 — ThermoNeuroModulation Device, TNM DeviceScion Neurostim, LLC Mar 26, 2018
K180315 — DISKOMBiopsybell S.R.L. Mar 26, 2018
K172017 — Black Silicone Filiform Double Pigtail Stent SetCook Incorporated Mar 26, 2018
K173310 — SmartTouchAdherium (Nz), Ltd. Mar 26, 2018
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