510(k) Clearances in 2017 — Page 50

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 50 of 64)
510(k) clearancesDetails
K170781 — MX50N(MX50YQS)Wide Corporation Apr 4, 2017
K162544 — OsteoMed PINNACLE DriverOsteomed Apr 4, 2017
K163426 — ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionAsahi Intecc Co., Ltd. Apr 3, 2017
K161353 — ESTELITE BULK FILL FlowTokuyama Dental Corporation Apr 3, 2017
K162241 — TITAN 3-D™ Wedge SystemParagon 28 Apr 3, 2017
K170075 — AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)Airxpanders, Inc. Apr 3, 2017
K162167 — Caphosol Artifical Saliva TabletsEusa Pharma (Uk) Limited Mar 31, 2017
K163350 — Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona Mar 31, 2017
K162413 — AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization SystemSTERIS Corporation Mar 31, 2017
K170628 — BioMonitor 2-AF, BioMonitor 2-SBiotronik, Inc. Mar 31, 2017
K161635 — AMIStem-H Proximal CoatingMedacta International S.A. Mar 31, 2017
K162530 — Multichem IA PlusTechno-Path Manufacturing Mar 31, 2017
K162873 — MEP MonitorTonica Elektronik A/S Mar 31, 2017
K161257 — MultiPulse HoPLUSAsclepion Laser Technologies GmbH Mar 31, 2017
K162559 — Move Forward 3D Motion Simulation ServiceBiomet, Inc. Mar 31, 2017
K163096 — GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited Mar 31, 2017
K170622 — Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentCook Incorporated Mar 31, 2017
K161530 — Bluetooth blood pressure monitorShenzhen Kingyield Technology Co., Ltd. Mar 31, 2017
K162820 — AC3 Series IABP SystemArrow International, Inc. Mar 31, 2017
K170098 — ICONIX TT All Suture AnchorStryker Mar 31, 2017
K162627 — EnsoSleepEnsodata, Inc. Mar 31, 2017
K162626 — THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVETop Quality Glove Sdn. Bhd Mar 31, 2017
K163649 — SureSigns VS3; SureSigns VS4Philips Medical Systems Mar 31, 2017
K170284 — Great Basin Bordetella Direct TestGreat Basin Scientific, Inc. Mar 31, 2017
K162186 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIMBrightway Holdings Sdn. Bhd. Mar 31, 2017
K170783 — CX50N(CX50YQS)Wide Corporation Mar 31, 2017
K170243 — LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd. Mar 31, 2017
K170449 — Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protectionMillennium Medical Technologies, Inc. Mar 31, 2017
K162309 — StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. Mar 31, 2017
K170327 — Parcus SLiK AnchorsParcus Medical Mar 30, 2017
K170271 — NuVasive(r) Monolith Corpectomy SystemNu Vasive, Incorporated Mar 30, 2017
K170077 — LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd. Mar 30, 2017
K170009 — Esophageal Cooling DeviceAdvanced Cooling Therapy, LLC Mar 30, 2017
K170310 — Alians Clavicle rangeNewclip Technics Mar 30, 2017
K162471 — Hach CM130 Chlorine Monitoring SystemHach Company Mar 30, 2017
K162995 — Ibis® Pedicle Screw SystemOrtho Development Corporation Mar 30, 2017
K170635 — Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. Mar 30, 2017
K170743 — AngioDynamics Total Abscession Biliary Drainage CatheterAngioDynamics, Inc. Mar 30, 2017
K163700 — Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. Mar 29, 2017
K163529 — ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)Avery Dennison Corporation Mar 29, 2017
K170654 — USS SystemSynthes USA Products, LLC Mar 29, 2017
K160665 — FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Maquet Critical Care AB Mar 29, 2017
K162999 — V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil SystemMicroVention, Inc. Mar 29, 2017
K163052 — Brevera Biopsy System with Corlumina Imaging TechnologyHologic, Inc. Mar 29, 2017
K161929 — Palm-Pro Chemo-Guard Nitrile Powder Free Examination GloveDipped Products (Thailand) Limited Mar 29, 2017
K170161 — New Deantronics E Green™ Electrosurgical Monopolar PencilsNew Deantronics Taiwan , Ltd. Mar 29, 2017
K162693 — VertebraLINK Fusion PlatformFacetlink Dba Linkspine Mar 29, 2017
K162124 — Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning PinsDePuy Synthes Mar 29, 2017
K161816 — BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUObioMerieux, Inc. Mar 28, 2017
K163565 — MR8 Drill SystemMedtronic Powered Surgical Solutions Mar 28, 2017
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