510(k) Clearances in 2018 — Page 25

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 25 of 62)
510(k) clearancesDetails
K181962 — CubeVueCurvebeam, LLC Aug 7, 2018
K181828 — Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard ProfileScientia Vascular, LLC Aug 7, 2018
K181234 — Self-adhesive ElectrodeDong Guan OU Kang Electronics Co., Ltd. Aug 7, 2018
K173848 — Model WP-3840 and WP-3040Cnmc Co., Inc. Aug 7, 2018
K181346 — CystoSure Plus CatheterEmmy Medical, LLC Aug 6, 2018
K180853 — EP Granules™ BVFElute, Inc. Aug 6, 2018
K180075 — MINUET LCD, MINUET LCD ecoUnimom.Co Aug 6, 2018
K173845 — Arthrex SwiveLockArthrex, Inc. Aug 6, 2018
K181425 — APTUS® Proximal Humerus SystemMedartis AG Aug 5, 2018
K181217 — VesoFlow Lite DVT Compression DeviceCaremed Supply, Inc. Aug 5, 2018
K180155 — Arm Type Blood Pressure MonitorAvita Corporation Aug 3, 2018
K171435 — VirtuOst Vertebral Fracture AssessmentO.N. Diagnostics, LLC Aug 3, 2018
K180341 — FUJIFILM 600 Series Endoscope EG-600WR v2Fujifilm Corporation Aug 3, 2018
K181237 — Glidesheath Slender Tibial Pedal KitTerumo Medical Corporation Aug 3, 2018
K180825 — Fluent Fluid Management SystemHologic, Inc. Aug 3, 2018
K180777 — K2M Expandable Interbody SystemK2M, Inc. Aug 3, 2018
K181149 — Therm-X Pro, Therm-X AT, Therm-X Pro AthleteZenith Technical Innovations Aug 3, 2018
K181797 — Philips CT Big Bore Sliding Gantry ConfigurationPhillips Medical Systems (Cleveland), Inc. Aug 3, 2018
K173461 — ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL Aug 3, 2018
K181479 — Ingenia Ambition S and Ingenia Ambition XPhilips Medical Systems Nederland B.V. Aug 3, 2018
K172280 — BH Sterilization PouchBh Medical Products Co., Ltd. Aug 3, 2018
K163578 — EasyTouch Safety Pen NeedleMhc Medical Products, LLC Aug 3, 2018
K181146 — ASK SystemL And K Biomed Corporation Limited Aug 3, 2018
K181323 — Atlas Gold PTA Dilatation CatheterC.R. Bard, Inc. Aug 3, 2018
K181809 — GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL Aug 3, 2018
K181197 — PHMB Foam Wound DressingAdvanced Medical Solutions, Ltd. Aug 3, 2018
K180907 — HORIZON TMS Therapy SystemMagstim Company, Ltd. Aug 3, 2018
K181219 — OptiPillows EPAP MaskCpapnea Medical Supply Aug 3, 2018
K181549 — Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)Curiteva, LLC Aug 3, 2018
K181796 — FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook DimensionsAlcon Laboratories, Inc. Aug 3, 2018
K181562 — Curiteva Anterior Cervical Plate SystemCuriteva, LLC Aug 2, 2018
K181094 — Polydioxanone Surgical ScaffoldLntegra Lifesciences Aug 2, 2018
K173869 — Med-link Reusable Blood Pressure CuffShenzhen Med-Link Electronics Tech Co., Ltd. Aug 2, 2018
K181830 — Azurion R2.0Philips Medical Systems Nederland B.V. Aug 2, 2018
K173280 — Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc. Aug 2, 2018
K173923 — Temporary Cardiac Pacing WireETHICON, Inc. Aug 2, 2018
K181007 — Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc. Aug 2, 2018
K181182 — DYNACORD SutureMedos International SARL Aug 2, 2018
K181257 — PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy Aug 2, 2018
K173531 — Lockbox for Perfusor Space PCA Infusion PumpB.Braun Medical, Inc. Aug 2, 2018
K181432 — ProVectra 3D Prime with VistaSoftDurr Dental SE Aug 2, 2018
K171547 — Qualisys Clinical SystemQualisys AB Aug 2, 2018
K180150 — PL8 Wrist Reconstruction PlateCitieffe S.R.L. Aug 2, 2018
K171977 — miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software And Technology, Ltd. Aug 2, 2018
K181804 — Alphenix, INFX-8000C/B, V8.0Canon Medical Systems Corporation Aug 2, 2018
K181772 — NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)Ceterix Orthopaedics, Inc. Aug 1, 2018
K180764 — TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)Church & Dwight Co., Inc. Aug 1, 2018
K180770 — Propeller Sensor for NeohalerReciprocal Labs Corporation Aug 1, 2018
K181480 — MMD TipStrata Skin Sciences, Inc. Aug 1, 2018
K180737 — Ultrasound Scanner System bk2300Bk Medical Aps Aug 1, 2018
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