510(k) Clearances in 2018 — Page 61

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 61 of 62)
510(k) clearancesDetails
K172929 — Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal SheathBoston Scientific Corporation Jan 10, 2018
K173768 — Tempus Pro Patient MonitorRemote Diagnostic Technologies , Ltd. Jan 10, 2018
K171722 — Electrodes with snap / Electrodes with pigtailShenzhen Konmed Technology Co., Ltd. Jan 10, 2018
K172336 — Smith & Nephew Patient Matched Cutting BlocksSmith & Nephew, Inc. Jan 10, 2018
K172051 — Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide CatheterCook Incorporated Jan 10, 2018
K171421 — VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH Jan 10, 2018
K173563 — ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICETz Medical, Inc. Jan 10, 2018
K173170 — Epicardia AnywhereMedicomp, Inc. Jan 10, 2018
K172193 — Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser ModulesAlma Lasers, Inc. Jan 9, 2018
K173021 — Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic SystemsSupersonic Imagine Jan 9, 2018
K171775 — Theradome LH80 PROTheradome, Inc. Jan 9, 2018
K173508 — Everest Spinal SystemK2M Jan 9, 2018
K173263 — Xpert Carba-RCepheid Jan 9, 2018
K172212 — MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation Jan 9, 2018
K173469 — 16ch T/R Hand Wrist CoilQuality Electrodynamics, LLC Jan 9, 2018
K163027 — Ultra/Phonic Free Conductivity GelPharmaceutical Innovations, Inc. Jan 9, 2018
K172183 — Guided Growth Plate System PlusOrthofix Srl Jan 9, 2018
K171295 — ULab Systems Treatment Planning SoftwareUlab Systems, Inc. Jan 9, 2018
K163026 — Ultra/Phonic Scanning GelPharmaceutical Innovations, Inc. Jan 9, 2018
K172662 — reVive PerioralLed Technologies, Inc. Jan 9, 2018
K171328 — cNeuro cMRICombinostics OY Jan 8, 2018
K172942 — Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable proteinBeta Healthcare Products Pvt., Ltd. Jan 8, 2018
K163024 — Ultra/Phonic Conductivity GelPharmaceutical Innovations, Inc. Jan 8, 2018
K173159 — Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc. Jan 8, 2018
K173085 — invendoscopy E210 SystemInvendo Medical GmbH Jan 8, 2018
K163023 — Other-Sonic Transmission GelPharmaceutical Innovations, Inc. Jan 8, 2018
K173293 — EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc. Jan 8, 2018
K172858 — PreOpEpilog Jan 8, 2018
K173759 — Thermage CPT System and AccessoriesSolta Medical Jan 8, 2018
K173471 — DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 DiagnosticShenzhen Mindray Bio-Medical Electronics Co., Ltd. Jan 8, 2018
K172518 — Spineology Navigation InstrumentsSpineology, Inc. Jan 5, 2018
K171860 — Sureclear alignersEmergo Global Consulting, LLC Jan 5, 2018
K171721 — Electrodes with silver conductiveShenzhen Konmed Technology Co., Ltd. Jan 5, 2018
K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCPPulpdent Corporation Jan 5, 2018
K172029 — EnsoETMAttune Medical Jan 5, 2018
K173456 — ViewPoint 6Ge Medical Systems Ultrasound And Primary Jan 5, 2018
K172968 — Hair UpY & J Bio Co., Ltd. Jan 5, 2018
K171518 — Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd. Jan 5, 2018
K171099 — EON Portable Reverse Osmosis Water Purification SystemCantel Jan 5, 2018
K173650 — AquaShield System CO2- FujifilmUnited States Endoscopy Group, Inc. Jan 5, 2018
K171436 — STRONG Dental HandpiecesSaeshin Precision Co., Ltd. Jan 5, 2018
K171948 — Roadrunner Extra Support Wire GuideCook Incorporated Jan 5, 2018
K173252 — BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)Becton, Dickinson And Company Jan 5, 2018
K173278 — ToggleLoc SystemBiomet, Inc. Jan 5, 2018
K171410 — ePatchBraemar Manufacturing, LLC Jan 4, 2018
K172701 — BIO-C SEALERAngelus Industria DE Produtos Odontologicos S/A Jan 4, 2018
K172702 — Tec 820, Tec 850Datex-Ohmeda, Inc. Jan 4, 2018
K172456 — Bone Screws 6.5mmLima Corporate S.P.A. Jan 4, 2018
K171372 — Alians Elbow Locking Plating SystemNewclip Technics Jan 4, 2018
K171819 — Attain Assist CS Access CatheterCreganna Medical Also Doing Business AS Ceganna Tactx Medica Jan 4, 2018
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