510(k) Clearances in 2018 — Page 52

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 52 of 62)
510(k) clearancesDetails
K172590 — Spectra Optia Apheresis SystemTerumobct, Inc. Mar 2, 2018
K173624 — ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)Origio A/S Mar 2, 2018
K172331 — Type I, Type II, Type III, Type IVLepu Medical Technology (Beijing) Co., Ltd. Mar 2, 2018
K173346 — LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. Mar 2, 2018
K172485 — Footmotion HammerToeNewclip Technics Mar 2, 2018
K173223 — ologen Collagen MatrixAeon Astron Europe B.V. Mar 2, 2018
K171214 — Infrared ThermometerShenzhen Brav Electronic Technologies Co., Ltd. Mar 2, 2018
K171129 — CO Check Pro, CO ScreenMD Diagnostics Limited Mar 2, 2018
K170304 — Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizersAstell Scientific Limited Mar 2, 2018
K173312 — ProBx SoftwareHarmonus, Inc. Mar 2, 2018
K173281 — LigaSure Exact Dissector, Nano-coatedCovidien Mar 2, 2018
K173447 — V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy UnitKci USA, Inc. Mar 2, 2018
K173256 — System 1 endo Liquid Chemical Sterilant Processing SystemSTERIS Corporation Mar 2, 2018
K180265 — COMPACT TOUCH Ophthalmic Ultrasound SystemQuantel Medical Mar 2, 2018
K172256 — SoftVueDelphinus Medical Technologies Mar 2, 2018
K173428 — VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation Mar 2, 2018
K171655 — cobas m 511 integrated hematology analyzerRoche Diagnostics Hematology, Inc. Mar 2, 2018
K172601 — Next Generation iBOTDeka Research & Development Corp. Mar 2, 2018
K172972 — Wrist Type Automatic Blood Pressure MonitorShenzhen Jiacom Technology CO ., Ltd. Mar 2, 2018
K172135 — uCT Computed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd. Mar 2, 2018
K162366 — Omega VLOv World Co., Ltd. Mar 2, 2018
K173544 — Phoenix Wound MatrixNanofiber Solutions, Inc. Mar 2, 2018
K172103 — Flowtron DVT5 Small Calf GarmentGetinge (Suzhou) Co., Ltd. Mar 2, 2018
K173704 — ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control StripPhadia AB Mar 2, 2018
K172820 — Microscope Navigation SoftwareBrainlab AG Mar 1, 2018
K172500 — Technoweb Surgical MaskYts Global, Inc. Mar 1, 2018
K173488 — CELERITY 20 HP Challenge PackSTERIS Corporation Mar 1, 2018
K172916 — FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603Fujifilm Corporation Mar 1, 2018
K171915 — Nathanson Transcystic Bile Duct Stone Exploration PackCook Incorporated Mar 1, 2018
K173806 — CorPath GRX SystemCorindus, Inc. Mar 1, 2018
K180109 — STARband, STARlight, St. Louis BandOrthomerica Products, Inc. Mar 1, 2018
K171703 — PUMA SystemPanther Orthopedics, Inc. Mar 1, 2018
K173788 — Arthrex Corkscrew FTArthrex, Inc. Mar 1, 2018
K173680 — Sapphire II PROOrbusneich Medical Trading, Inc. Mar 1, 2018
DEN160029 — SkinPen Precision SystemBellus Medical, LLC Mar 1, 2018
K173729 — REVIAN REDPhotonmd, Inc. Feb 28, 2018
K173707 — P200TEOptos Plc. Feb 28, 2018
K172750 — Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Guangzhou Sonostar Technologies Co., Ltd. Feb 28, 2018
K180244 — EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical Feb 28, 2018
K173763 — iovera systemMyoscience, Inc. Feb 28, 2018
K172797 — ECG Cable/LeadwiresShenzhen Coreray Technology, Ltd. Feb 28, 2018
K180255 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd. Feb 28, 2018
K173145 — CereMetrix SilverCeremetrix Corp Feb 28, 2018
K173186 — S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75DEveryway Medical Instruments Co.,Ltd Feb 28, 2018
K173633 — VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker TagSTERIS Corporation Feb 28, 2018
K173736 — TrackXTrack X Technology, LLC Feb 28, 2018
K173367 — MC 300* NebulizerTrudell Medical International Feb 28, 2018
K173817 — Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mLLiofilchem S.R.L. Feb 28, 2018
K180242 — HeRO Symphony, HeRO ES, HeRO solo/duetMedical Predictive Science Corporation Feb 28, 2018
K173739 — ALOKA ARIETTA 850Hitachi Healthcare Americas Corporation Feb 28, 2018
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