510(k) Clearances in 2019 — Page 35

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 35 of 59)
510(k) clearancesDetails
K183630 — SPINEART Navigation Instrument SystemSpineart SA Jun 10, 2019
K190814 — AccuFill Bone Substitute MaterialZimmer Knee Creations Jun 10, 2019
K182650 — Arzzt Distal Radius and Ulna SystemTruemed Group, LLC Jun 10, 2019
K190220 — Vista FS, Vista FS LiquidInter-Med/Vista Dental Products Jun 10, 2019
K191310 — Insight Essentials DRF Digital Imaging SystemImaging Engineering, LLC Jun 10, 2019
K183104 — Mini Cannulated Headed and Headless Screw SetStryker GmbH Jun 10, 2019
K191072 — 7410 Ultrasound System (MyLabSigma)Esaote, S.P.A. Jun 10, 2019
K190216 — SpaceFlex KneeG21, S.R.L. Jun 9, 2019
K190051 — TD ClipZephyr Sleep Technologies, Inc. Jun 7, 2019
K183632 — Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology CableBaylis Medical Company, Inc. Jun 7, 2019
K182145 — tün® ultrasonic tips product familyEngineered Endodontics Jun 7, 2019
K182429 — Masimo O3 Regional Oximeter SystemMasimo Corporation Jun 7, 2019
K191316 — VITROS XT Chemistry Products ALB-TP SlidesOrtho-Clinical Diagnostics, Inc. Jun 7, 2019
K190057 — DJO Acetabular SystemEncore Medical L.P. Jun 7, 2019
K183311 — Ivenix Infusion System (IIS)Ivenix, Inc. Jun 7, 2019
K190916 — VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc. Jun 7, 2019
K190388 — RIVAL View Plating Systems and Reduce Fracture Plating SystemsOrthofix Srl Jun 7, 2019
DEN180057 — IB-StimInnovative Health Solutions (Ihs), Inc. Jun 7, 2019
K182519 — Miha Bodytec IIMiha Bodytec GmbH Jun 7, 2019
K183229 — Argen Clear AlignerArgen Corporation Jun 7, 2019
K182573 — Hailie SensorAdherium (Nz), Ltd. Jun 7, 2019
K191231 — Andorate Auxiliary Water Connector, Andorate Valves SetSmartdata Suzhou Co., Ltd. Jun 7, 2019
K183649 — Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology CableBaylis Medical Company, Inc. Jun 7, 2019
K190503 — CeraSealMeta Biomed Co., Ltd. Jun 7, 2019
K180952 — Ceramic BracketMem Dental Technology Co., Ltd. Jun 7, 2019
K191220 — Pure Vu SystemMotus GI Medical Technologies , Ltd. Jun 6, 2019
K191335 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsCorinth Medtech, Inc. Jun 6, 2019
K191263 — Idys ALIF TiVacClariance, Sas Jun 6, 2019
K183620 — PROSTEP TBC Implant SystemWrightmedicaltechnologyinc Jun 6, 2019
K191043 — da Vinci Handheld CameraIntuitive Surgical, Inc. Jun 6, 2019
K190827 — Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidUvision360, Inc. Jun 6, 2019
K190618 — RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC Jun 6, 2019
K190568 — ComPAS2 (Computerized Pulmonary Analysis System)Morgan Scientific, Inc. Jun 6, 2019
K190616 — VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)bioMerieux, Inc. Jun 6, 2019
K190804 — HydroCision TenJet DeviceHydrocision, Inc. Jun 5, 2019
K180671 — MINERht Co., Ltd. Jun 5, 2019
K190874 — Materialise Mimics EnlightMaterialise NV Jun 5, 2019
K183114 — Corin BiPolar-iCorin U.S.A. Limited Jun 5, 2019
K190505 — Low Dose Lung Screening OptionCanon Medical Systems Corporation Jun 5, 2019
K190576 — WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation Jun 5, 2019
K183559 — WatchPAT ONEItamar Medical , Ltd. Jun 5, 2019
K190585 — Biocode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc. Jun 5, 2019
K191307 — Palm Bladder Scanner - PBSV5.1Mianyang Meike Electronic Equipment Co., Ltd. Jun 5, 2019
K190595 — Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) Jun 5, 2019
K190245 — PDS Barbed Suture, PDO MAXX ThreadsPdo Max, Inc. Jun 4, 2019
K191340 — CORTRAK* 2 Equilateral Enteral Access SystemAvanos Medical, Inc. Jun 4, 2019
K190068 — Vanguard XP Knee SystemZimmer, Inc. Jun 4, 2019
K190892 — MectaScrew PEEK Interference ScrewMedacta International S.A. Jun 4, 2019
K183535 — Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. Jun 4, 2019
K190579 — TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation Jun 4, 2019
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