510(k) Clearances in 2017 — Page 53

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 53 of 64)
510(k) clearancesDetails
K161416 — Multi-unit Abutment PlusNobel Biocare AB Mar 16, 2017
K163471 — Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC Mar 16, 2017
K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CALSiemens Healthcare Diagnostics Mar 16, 2017
K162070 — JOINIX CANNULAR SYSTEMAju Pharm Co., Ltd. Mar 16, 2017
K170451 — FDX Console (DR-ID300CL) SoftwareFujifilm Medical Systems U.S.A, Inc. Mar 16, 2017
K163498 — VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC Mar 16, 2017
K162905 — SleepWeaver 3D Nasal MaskCircadiance, LLC Mar 15, 2017
K163572 — LV Liberty Vision Model 1 90 Yttrium Brachytherapy SourceLv Liberty Vision Corp. Mar 15, 2017
K163364 — MOJAVE Expandable Interbody SystemK2M Mar 15, 2017
K162415 — Spectra 9PlusUzinmedicare Company Mar 15, 2017
K163517 — Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mLLiofilchem S.R.L. Mar 14, 2017
K161880 — NIVR58-T kitBarco N.V. Mar 14, 2017
K161785 — THD ANOPRESSThd Spa Mar 14, 2017
K163093 — Safety Blood Collection SetJiangsu Shenli Medical Production Co., Ltd. Mar 14, 2017
K162960 — TotalC-RamItena Clinical Mar 14, 2017
K161598 — NobelZygoma 0°Nobel Biocare AB Mar 14, 2017
K170127 — HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40Hardy Diagnostics Mar 14, 2017
K160287 — Rapid Barostat Bag (RBB) Pump and CatheterMui Scientific Mar 14, 2017
K163522 — FilmArray Warrior Control Panel M290Maine Molecular Quality Controls, Inc. Mar 14, 2017
K162429 — ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC Mar 13, 2017
K162921 — Navigated Instrument SystemOrthofix, Inc. Mar 13, 2017
K170116 — Thermi Injectable RF ElectrodesThermi Mar 13, 2017
K162654 — mollosil plusDetax GmbH & Co. KG Mar 13, 2017
K163563 — VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)bioMerieux, Inc. Mar 13, 2017
K163039 — ORTHOLOC® 3Di Small Bones PlatingWrightmedicaltechnologyinc Mar 13, 2017
K162836 — FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. Mar 13, 2017
K170030 — NOVATECH TALCAIRNovatech SA Mar 13, 2017
K163152 — PROLENE Soft Polypropylene MeshETHICON, Inc. Mar 11, 2017
K162589 — Adscope 658 Electronic StethoscopeAmerican Diagnostic Corp. Mar 10, 2017
K162509 — Infrared Non-contact Thermometer, Model ACT8100Easywell Biomedicals, Inc. Mar 10, 2017
K162935 — Rapid2 Therapy SystemMagstim Company, Ltd. Mar 10, 2017
K160815 — Interstitial NeedlesVarian Medical Systems, Inc. Mar 10, 2017
K163495 — AdvanCE capsule endoscope delivery deviceUnited States Endoscopy Group, Inc. Mar 10, 2017
K170512 — Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC Mar 10, 2017
K170508 — EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 ReloadsIntuitive Surgical, Inc. Mar 10, 2017
K163474 — CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc. Mar 10, 2017
K170084 — InterLock TrocarFujifilm New Development U.S.A., Inc. Mar 10, 2017
K162793 — RHYTHMIA HDx Mapping SystemBoston Scientific Corporation Mar 10, 2017
K163376 — Mikro-Cath Pressure CatheterMillar, Inc. Mar 10, 2017
K162733 — iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. Mar 10, 2017
K170336 — BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson And Company Mar 10, 2017
K163629 — Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd. Mar 10, 2017
K170391 — ANSiStim-PPDyansys, Inc. Mar 9, 2017
K170065 — ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc. Mar 9, 2017
K162412 — Hoggan Scientific® microFET2™Hoggan Scientific, LLC Mar 9, 2017
K170528 — Sterispine™ PSSafe Orthopaedics Mar 9, 2017
K170126 — NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated Mar 9, 2017
K170124 — Level One Hand Plating SystemKLS Martin L.P. Mar 9, 2017
K163604 — SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation Mar 9, 2017
K170267 — BGM009 Plus Blood Glucose Monitoring SystemApex BioTechnology Corp. Mar 9, 2017
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