510(k) Clearances in 2017 — Page 28

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 28 of 64)
510(k) clearancesDetails
K172004 — truSculptCutera, Inc. Aug 2, 2017
K170712 — Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. Aug 2, 2017
K171172 — Skyn Original Polyisoprene Lubricated Male Condom - FlavoredAnsell Healthcare Products, LLC Aug 2, 2017
K171038 — Hearing Healthcare ProDb Diagnostic Systems, Inc. Aug 2, 2017
K171906 — Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mLLiofilchem S.R.L. Aug 1, 2017
K171079 — Q-Switched Nd:YAG Laser SystemIds, Ltd. Aug 1, 2017
K171315 — Advanced RBC ApplicationCellaVision AB Aug 1, 2017
K170285 — AED SinuscopeNational Advanced Endoscopy Devices, Inc. Aug 1, 2017
K171758 — M.U.S.T. Combined Set ScrewsMedacta International S.A. Aug 1, 2017
K171062 — BP5S Wireless Blood Pressure MonitorAndon Health Co, Ltd. Aug 1, 2017
K171870 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mLThermo Fisher Scientific Aug 1, 2017
K171075 — Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. Aug 1, 2017
K171077 — HEXA100 (hexafocon A) Daily Wear Contact LensesContamac, Ltd. Aug 1, 2017
K171639 — Trojan Supra Lubricated Polyurethane Male CondomChurch & Dwight Co., Inc. Aug 1, 2017
K171975 — HardyDisk AST Delafloxacin 5 µg (DLX5)Hardy Diagnostics Aug 1, 2017
K170565 — LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc. Aug 1, 2017
K171369 — M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. Aug 1, 2017
K171619 — 14Fr Colon Decompression Set, Macon Colon Decompression SetCook Ireland, Ltd. Aug 1, 2017
K170894 — Zirconia Dental CeramicsChengdu Besmile Biotechnology Co., Ltd. Aug 1, 2017
K170885 — DD cubeX2 HSDental Direkt GmbH Aug 1, 2017
K171588 — NuBODY Skin Toning DeviceCarol Cole Company Dba Nuface Jul 31, 2017
K161845 — Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. Jul 31, 2017
K163127 — bellavista 1000Imtmedical AG Jul 31, 2017
K171623 — Nasal Pancreatic Drainage SetCook Ireland, Ltd. Jul 31, 2017
K171615 — Xingyu Nitrile Powder Free Patient Examination Gloves, White colorShandong Xingyu Gloves Co., Ltd. Jul 31, 2017
K171132 — Carefusion NeutraClear Needle-free connectorCair Lgl Jul 31, 2017
K171999 — Performer IntroducerCook Incorporated Jul 31, 2017
K171301 — Scanmate FlexDgh Technology, Inc. Jul 31, 2017
K170842 — WEGO-PTFEFoosin Medical Supplies Inc., Ltd. Jul 31, 2017
K163598 — Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical IndicatorAdvanced Sterilization Products Jul 31, 2017
K172025 — Litho 60Quanta System Spa Jul 31, 2017
K170207 — ObturysItena Clinical Jul 31, 2017
K171040 — Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeKoelis Jul 31, 2017
K163136 — Youha electric breast pumpNingbo Youhe Electrical Appliance Technology Co., Ltd. Jul 31, 2017
K171607 — Bronchi and Gastrointestinal Cytology BrushWilson-Cook Medical Inc./Cook Endoscopy Jul 31, 2017
K163352 — WheelchairKunshan Hi-Fortune Health Products Co., Ltd. Jul 28, 2017
K170187 — Photodynamic Therapy DeviceUvbiotek, LLC Jul 28, 2017
K171699 — da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. Jul 28, 2017
K171054 — Biomet Knee Joint Replacement ProsthesesBiomet, Inc. Jul 28, 2017
K171103 — Lumipulse G TSH-III Immunoreaction CartridgesFujirebio Diagnostics,Inc. Jul 28, 2017
K163048 — Smart Stitching Software System, Image Processing, RadiologicalOsko, Inc. Jul 28, 2017
K162951 — TUBETECH IV Administration SetDouglas Medical Products, Inc. Jul 28, 2017
K163259 — AXS Offset Delivery Assist CatheterStryker Neurovascular Jul 28, 2017
K171945 — Discovery Pico, Discovery Pico PlusQuanta System Spa Jul 28, 2017
K171754 — NovaPACSNovarad Corporation Jul 28, 2017
K171265 — Otowave 302 Portable TympanometerAmplivox, Ltd. Jul 28, 2017
K163633 — cobas HbA1c Test, cobas b 101 systemRoche Diagnostics Operations Jul 28, 2017
K171602 — Williams Cystoscopic Injection NeedleCook Incorporated Jul 28, 2017
K163177 — ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAImmco Diagnostics, Inc. Jul 28, 2017
K172013 — VitalBeamVarian Medical Systems, Inc. Jul 28, 2017
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