510(k) Clearances in 2018 — Page 28

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 28 of 62)
510(k) clearancesDetails
K181342 — JGH1 Bone Graft SubstituteAgNovos Healthcare USA, LLC Jul 19, 2018
K181345 — Image Filing Software NAVIS-EXNidek Co., Ltd. Jul 19, 2018
K173585 — da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. Jul 19, 2018
K172857 — Latitud Hip Replacement SystemMeril Healthcare Pvt. , Ltd. Jul 19, 2018
K173911 — Medline Burn and Wound DressingMedline Industries, Inc. Jul 19, 2018
K180763 — CuffLink Implant System BiocompositeConmed Corporation Jul 19, 2018
K180419 — Ultrasonic Doppler (Model YM-2T8)Shenzhen Imdk Medical Technology Co., Ltd. Jul 19, 2018
K181623 — Clarifi Imaging SystemModulated Imaging, Inc. Jul 19, 2018
K171011 — PENTAX Medical VIVIDEO ENT Videoscope SolutionPentax Medical Jul 18, 2018
K181062 — Ultra Facial Toning SystemMicro Current Technology, Inc. Jul 18, 2018
K173829 — NeoLSD MSMS kitWallac Oy, A Subsidiary Of Perkinelmer Jul 18, 2018
K173327 — DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd. Jul 18, 2018
K180784 — ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ESAsahi Intecc Co., Ltd. Jul 18, 2018
K180977 — KARL STORZ New Generation TrocarsKARL STORZ Endoscopy-America, Inc. Jul 18, 2018
K173487 — CarboClear® Pedicle Screw SystemCarboFix Orthopedics , Ltd. Jul 18, 2018
K181014 — Tritanium PL CageStryker Spine Jul 18, 2018
K181015 — Braun BFH175 Infrared Forehead ThermometerKaz USA, Inc., A Helen Of Troy Company Jul 18, 2018
K181189 — ATLANTIS Conus StructureDentsply Sirona Jul 18, 2018
K172653 — Power InfuserZOLL Medical Corporation Jul 18, 2018
K172389 — ePTFE-Coated Auricular ImplantImplantech Associates, Inc. Jul 18, 2018
K170820 — Capnograph and OximeterCmi Health, Inc. Jul 18, 2018
K173762 — AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersAngioDynamics, Inc. Jul 18, 2018
K181376 — ARIETTA 65Hitachi Healthcare Americas Corporation Jul 18, 2018
K181079 — SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation Jul 18, 2018
K180027 — ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC Jul 18, 2018
K181030 — Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC Jul 17, 2018
K180348 — Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd. Jul 17, 2018
K180915 — Sonicision Reusable Sterilization TrayCovidien Jul 17, 2018
K171272 — Cook-Swartz Doppler Flow ProbeCook Incorporated Jul 17, 2018
K173654 — Ureteral Dilator Sets, Ureteral DilatorsCook Incorporated Jul 17, 2018
K181375 — Apex Femoral Nailing SystemOrthoxel Jul 17, 2018
K173968 — Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG Jul 17, 2018
K180269 — Cadwell Apollo SystemCadwell Industries, Inc. Jul 17, 2018
K173797 — Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation Jul 17, 2018
K180526 — EIDON FACentervue S.P.A. Jul 16, 2018
K181115 — CxHA PEEK Cervical IBF SystemInnovasis, Inc. Jul 16, 2018
K181600 — PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. Jul 16, 2018
K181016 — Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemWelch Allyn, Inc. Jul 16, 2018
K181002 — Atellica IM BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc. Jul 16, 2018
K180534 — Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH Jul 16, 2018
K181019 — Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd. Jul 16, 2018
K180151 — MC3 Jugular Dual Lumen CatheterMc3 Incorporated Jul 16, 2018
K181300 — Embosphere MicrospheresBiosphere Medical, S.A. Jul 16, 2018
K181029 — Solana Bordetella Complete AssayQuidel Corporation Jul 15, 2018
K173909 — Dimension Hemoglobin A1c AssaySiemens Healthcare Diagnostics, Inc. Jul 13, 2018
K180011 — Pulmonx Chartis Tablet ConsolePulmonx Corporation Jul 13, 2018
K181565 — Aquarius 8600 Digital Radiography SensorBiokinemetrics, Inc. Jul 13, 2018
K181134 — G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral SpraySunstar Americas, Inc. Jul 13, 2018
K180654 — PINXEL-RF systemRohrer Aesthetics, LLC Jul 13, 2018
K181556 — EliA M2 ImmunoassayPhadia AB Jul 13, 2018
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