510(k) Clearances in 2018 — Page 56

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 56 of 62)
510(k) clearancesDetails
K172504 — Tosama Biobased Applicator Tube Menstrual TamponTosama, D.O.O. Feb 9, 2018
K171755 — CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC Feb 9, 2018
K173400 — ORISE Tissue Retractor SystemBoston Scientific Feb 9, 2018
K173435 — 3M Attest Rapid Readout Biological Indicator3M Company Feb 9, 2018
K172754 — V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation Feb 9, 2018
K172284 — NAPA LP-15 Airway Pressure MonitorDrw Medical, LLC Feb 9, 2018
K173501 — Meridian Vaginal Positioning System (VPS)Coloplast Feb 9, 2018
K171455 — AT-6XX Series Infrared ThermometerXiamen Acurio Instruments Co., Ltd. Feb 9, 2018
K172422 — Kohli Urinary Drainage CatheterNellie Medical, LLC Feb 9, 2018
K171631 — Standard Catheter SetVarian Medical Systems, Inc. Feb 9, 2018
K173791 — Leksell GammaPlanElekta Instrument AB Feb 9, 2018
K172746 — VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive LabelSTERIS Corporation Feb 9, 2018
K173523 — BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)Becton, Dickinson And Company Feb 9, 2018
K173272 — Ergonomic HandleSymmetry Surgical, Inc. Feb 9, 2018
K172753 — VERIFY VH2O2 Indicator TapeSTERIS Corporation Feb 9, 2018
K173244 — superDimension Navigation System V7.2Covidien, LLC Feb 8, 2018
K173335 — Gazelle PTFE and Suture Delivery DeviceDura Tap, LLC Feb 8, 2018
K180091 — UNiD Spine AnalyzerMedicrea International Feb 8, 2018
K180084 — Ultrasound System SONIMAGE MX1Konica Minolta, Inc. Feb 8, 2018
K173411 — Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp Feb 8, 2018
K173805 — NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)Marvao Medical Devices, Ltd. Feb 8, 2018
K173025 — NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF SystemNu Vasive, Incorporated Feb 8, 2018
K173553 — LUCAS 3 Chest Compression SystemJolife AB Feb 8, 2018
K173537 — CONCORDE LIFT™Medos International SARL Feb 8, 2018
K162727 — SENYINT Remote Consultation SystemDalian Senyint Digital Medical System Co., Ltd. Feb 8, 2018
K173450 — PRESS DUO elite, PRESS DUO elite AGNemoto Kyorindo Co., Ltd. Feb 7, 2018
K161222 — PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical Feb 7, 2018
K173199 — PicoSure WorkstationCynosure, Inc. Feb 7, 2018
K171861 — CAPILLARYS Hb A1cSebia Feb 7, 2018
K172698 — G-Beam Fusion Beaming SystemOrthofix Srl Feb 7, 2018
K173826 — THP Hip Fracture Plating SystemBiomet, Inc. Feb 7, 2018
K180067 — ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Feb 7, 2018
K171520 — SteriZign Signatur Device Protection SystemSterizign Precision Technologies, LLC Feb 7, 2018
K173882 — SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation Feb 6, 2018
K171375 — Gammex PI Breach Detect Powder Free Surgical GloveAnsell Healthcare Products, LLC Feb 6, 2018
K172953 — Acid EtchantAmerican Orthodontics Feb 6, 2018
K171641 — Accula Flu A/Flu B TestMesa Biotech, Inc. Feb 6, 2018
K172832 — Insight BDSiemens Medi Cal Solutions, Inc. Feb 6, 2018
K173528 — Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy SystemDevon Medical Products (Jiangsu), Ltd. Feb 6, 2018
K172490 — eUnityClient Outlook, Inc. Feb 6, 2018
K171557 — AcQRef Introducer SheathAcutus Medical, Inc. Feb 6, 2018
K171361 — BETTERCARE PLATFORM - ADVANCED WEB CLIENTBetter Care S.L. Feb 5, 2018
K171695 — First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test MarijuanaW.H.P.M., Inc. Feb 5, 2018
K173672 — FlowTriever Retrieval/Aspiration System, Aspiration Guide CatheterInari Medical Feb 5, 2018
K172040 — Aquilex Fluid Control System AQL-100SW.O.M. World Of Medicine GmbH Feb 5, 2018
K171208 — Trans-anal IntroducerVisionsense, Ltd. Feb 5, 2018
K173512 — MFI-CardiacMultifunctional Imaging, LLC Feb 5, 2018
K173924 — DRX-Revolution Nano Mobile X-ray SystemCarestream Health, Inc. Feb 5, 2018
K173433 — ProxiDiagnost N90Philips Medical Systems Dmc GmbH Feb 5, 2018
K173204 — RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Feb 5, 2018
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