510(k) Clearances in 2017 — Page 8

3,200 510(k) clearances total

Browse FDA 510(k) clearances granted in 2017. RegDataLab tracks 3,200 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2017 (page 8 of 64)
510(k) clearancesDetails
K172218 — MIM – Y90 DosimetryMim Software, Inc. Nov 21, 2017
K170915 — TXM Hydrophilic GuidewireTexasmedical Technologies, Inc. Nov 21, 2017
K172995 — Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding SheathTerumo Medical Corporation Nov 21, 2017
K170236 — Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. Nov 21, 2017
K170398 — S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. Nov 21, 2017
K172253 — Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC Nov 21, 2017
K171044 — Climax Personal LubricantWsm Investment, LLC, Dba Topco Sales Nov 21, 2017
K170914 — TXM Support CatheterTexasmedical Technologies, Inc. Nov 21, 2017
K170545 — Automatic Wrist Bluetooth Blood Pressure MonitorTruly Instrument , Ltd. Nov 21, 2017
K171650 — Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics Nov 21, 2017
K170754 — 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing3M Company, 3M Healthcare Nov 21, 2017
K173030 — Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated Nov 21, 2017
K172685 — LiverMultiScanPerspectum Diagnostics, Ltd. Nov 21, 2017
K172050 — Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB Nov 21, 2017
K163414 — Ultrasonic scalerNanning VV Dental Co., Ltd. Nov 21, 2017
K163579 — KLS Martin Individual Patient SolutionsKLS Martin L.P. Nov 21, 2017
K172924 — GentleCath Intermittent Urinary CatheterConvatec Limited Nov 21, 2017
K172580 — ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft LengthEthicon Endo-Surgery, LLC Nov 20, 2017
K172557 — Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps Nov 20, 2017
K173378 — syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH Nov 20, 2017
K172241 — Tyece OTC EMS System, Model EM35Tyece , Ltd. Nov 20, 2017
K173169 — Rapid FamilySharplight Technologies, Ltd. Nov 20, 2017
K173044 — Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffNingbo Albert Novosino Co., Ltd. Nov 20, 2017
K172921 — Stryker Self-Punching ICONIXStryker Nov 20, 2017
K171136 — LIA Pregnancy TestLia Diagnostics Nov 20, 2017
K171492 — B7 2C Occlusion BalloonSpiration, Inc. Nov 20, 2017
K172584 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps Nov 20, 2017
K172650 — Materialise PKA Guide SystemMaterialise NV Nov 20, 2017
K173018 — MDR17 Mobile Direct Radiographic SystemDel Medical, Inc. Nov 20, 2017
K172032 — Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. Nov 20, 2017
K172984 — Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive SurfaceMedtronic, Inc. Nov 20, 2017
K172514 — Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc. Nov 17, 2017
K171961 — Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)Xiamen Compower Medical Tech. Co., Ltd. Nov 17, 2017
K172472 — Micro-MEC 1.8% Glutaraldehyde Monitor StripSTERIS Corporation Nov 17, 2017
K172660 — Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC Nov 17, 2017
K171743 — Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination GlovesSmart Glove Corporation Sdn. Bhd. Nov 17, 2017
K173423 — MR Wire Guide Wire Straight, MR Wire Guide Wire AngledNano4Imaging GmbH Nov 17, 2017
K171589 — AEON Endoscopic StaplerLexington Medical, Inc. Nov 17, 2017
K173365 — Bausch + Lomb Boston Scleral Lens CaseBausch & Lomb, Incorporated Nov 17, 2017
K173023 — Symbia T16, Symbia Intevo 16 and Symbia Intevo BoldSiemens Medical Solutions USA, Inc. Nov 17, 2017
K172451 — Dr.MUSIC 3sSmartmedicaldevice Co., Ltd. Nov 17, 2017
K171158 — Single Use Electrosurgical knifeOlympus Medical Systems Corp. Nov 17, 2017
K172850 — SterilContainer with PrimeLine Pro LidAesculap, Inc. Nov 17, 2017
K171121 — Masimo Root Monitoring System and AccessoriesMasimo Corporation Nov 17, 2017
K173305 — NeuroBlate SystemMonteris Medical, Nov 17, 2017
K172363 — DEKA SMARTXIDE ULTRASPEEDEl.En Electronic Engineering Spa Nov 17, 2017
K170856 — CMS600P2 B-Ultrasound Diagnostic SystemContec Medical Systems Co.,Ltd Nov 17, 2017
K173068 — Performer IntroducerCook Incorporated Nov 17, 2017
K172318 — Endoform Silver Dermal TemplateAroa Biosurgery Nov 17, 2017
K173446 — Contour 24Quality Electrodynamics, LLC Nov 17, 2017
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