510(k) Clearances in 2017 — Page 29

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 29 of 64)
510(k) clearancesDetails
K162816 — SML-OSA2 AppliancesSelane Products, Inc. Jul 27, 2017
K171282 — Fully Automatic Blood Pressure MonitorAndon Health Co, Ltd. Jul 27, 2017
K172041 — truFreeze SystemCSA Medical, Inc. Jul 27, 2017
K163031 — Bunegin-Albin Air Aspiration SetCook Incorporated Jul 27, 2017
K170313 — ARIX Ankle Distal Tibia SystemJeil Medical Corporation Jul 27, 2017
DEN150053 — FETAL PILLOWSafe Obstetric Systems, Ltd. Jul 27, 2017
K171423 — Nasal Alar SpO2 SensorXhale, Inc. Jul 27, 2017
K163005 — TIGR Matrix Surgical MeshNovus Scientific AB Jul 27, 2017
K163597 — VacLok AT Vacuum SyringeMerit Medical Systems, Inc. Jul 27, 2017
K170563 — 3M Comply Hydrogen Peroxide Indicator Tape3M Company Jul 27, 2017
K171905 — VISCO 360 Viscosurgical SystemSight Sciences, Inc. Jul 27, 2017
K163536 — MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemBruker Daltonik GmbH Jul 26, 2017
K171515 — NHAC 16Lmt Medical Systems GmbH Jul 26, 2017
K170769 — wireless thermometerEch (Changzhou) Medical Instrument Co., Ltd. Jul 26, 2017
K162867 — MagDen Dental Implant SystemShinhung Mst Co., Ltd. Jul 26, 2017
K171727 — Hydrocleanse Antimicrobial Skin and Wound Care SolutionSonoma Pharmaceuticals Jul 26, 2017
K170812 — HygePLUS Alginate Impression MaterialHygedent, Inc. Jul 26, 2017
K170841 — BiopSee, Mobile USMedcom GmbH Jul 26, 2017
K163400 — Orbit InserterYpsomed AG Jul 26, 2017
K170867 — FTRD System SetOvesco Endoscopy AG Jul 25, 2017
K171967 — MagVita TMS Therapy SystemTonica Elektronik A/S Jul 25, 2017
K171645 — CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottleStrukmyer Medical Jul 25, 2017
K170997 — CARTO VIZIGO 8.5F Bi-Directional Guiding SheathBiosense Webster, Inc. Jul 25, 2017
K171885 — Radiance V4Gmv Soluciones Globales Internet S.A.U. Jul 25, 2017
K162312 — Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green ColorShen Wei USA, Inc. Jul 25, 2017
K170067 — EasyretQuantel Medical Jul 25, 2017
K171255 — Monteris Medical NeuroBlate SystemMonteris Medical, Inc. Jul 25, 2017
K171913 — Rubicon 14, 18 and 35 Support CathetersBoston Scientific Corporation Jul 25, 2017
K171837 — TomoTherapy Treatment Delivery System with iDMSAccuray Incorporated Jul 25, 2017
K170388 — ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical , Ltd. Jul 25, 2017
K170770 — CT MidlineMedical Components, Inc. (Dba MedComp) Jul 25, 2017
K171734 — HP PRO Positioning DeviceOrfit Industries NV Jul 25, 2017
K163062 — PHMB Antimicrobial Foam Wound DressingAdvanced Medical Solutions, Ltd. Jul 25, 2017
K170600 — CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. Jul 25, 2017
K170073 — LightMed Dental Laser SystemLightmed Dentaltechnology Corp. Jul 25, 2017
K171630 — LumFuse-TPPrecifit Medical, Ltd. Jul 25, 2017
K170305 — Spinal Manometer NRFit; Spinal Manometer LUERPAJUNK GmbH Medizintechnologie Jul 25, 2017
K163486 — DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking PlatesHnm Total Recon, LLC Jul 24, 2017
K171559 — True Spinal Fixation SystemInnovative Surgical Designs, Inc. Jul 24, 2017
K170923 — JAWS(TM) Nitinol Staple SystemParagon 28 Jul 24, 2017
K162858 — NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTCareplus (M) Sdn Bhd Jul 24, 2017
K171285 — ARIX Diaphysis SystemJeil Medical Corporation Jul 24, 2017
K163295 — Infant Transport Mattress Warmer with DiscRapid Aid Corp. Jul 24, 2017
K162633 — Custom BarsImplant Direct Sybron Manufacturing, LLC Jul 24, 2017
K171962 — Klassic HD® Hip SystemTotal Joint Othopedics, Inc. Jul 24, 2017
K162991 — YELLOW 560 Fluorescence ModuleCarl Zeiss Meditec, AG Jul 24, 2017
K171724 — Rampart L Lumbar Interbody Fusion DeviceSpineology, Inc. Jul 24, 2017
K171364 — MP LeFort I PlatesStryker Jul 24, 2017
K162950 — VITEK MSbioMerieux, Inc. Jul 22, 2017
K162778 — Portable Slit Lamp MicroscopeSuzhou Kangjie Medical, Inc. Jul 21, 2017
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