510(k) Clearances in 2017 — Page 15

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 15 of 64)
510(k) clearancesDetails
K172079 — AvailOmron Healthcare, Inc. Oct 19, 2017
K172527 — Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque StripeCook Incorporated Oct 19, 2017
K170261 — Premium Plus Prophy Air MotorPremium Plus International Limited Oct 19, 2017
K172297 — NovaCross MicrocatheterNitiloop , Ltd. Oct 18, 2017
K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayNuance Medical, LLC Oct 18, 2017
K171125 — Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact LensTangible Science, LLC Oct 18, 2017
K172034 — Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato TapStryker Corporation Oct 18, 2017
K172809 — OTC Combo TENS/EMS SystemWell-Life Healthcare Limited Oct 18, 2017
K170298 — Liberator Beacon Tip Locking StyletCook Incorporated Oct 18, 2017
K171579 — M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Oct 18, 2017
K171017 — Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16TConvaid Products, LLC Oct 18, 2017
K172608 — Medline ReNewal Reprocessed Stryker SERF AS Energy ProbesSurgical Instrument Service And Savings, Inc. Oct 18, 2017
K173101 — Curve Image 2.0 PACSCurve Dental, Ltd. Oct 18, 2017
K171068 — OrthoView 7.2Meridian Technique, Ltd. Oct 18, 2017
K172940 — ANCHOR Tissue Retrieval SystemConmed Corporation Oct 18, 2017
K172910 — Emit II Plus Oxycodone AssaySiemens Healthcare Diagnostics, Inc. Oct 18, 2017
K172801 — ECG SENTINEL SystemCardiomedix, Inc. Oct 18, 2017
K172728 — Applanation tonometer AT-1Takagi Seiko Co., Ltd. Oct 17, 2017
K172806 — Bencox Mirabo Cup SystemCorentec Co., Ltd. Oct 17, 2017
K172198 — 585Quanta System Spa Oct 17, 2017
K170538 — RVS-100 Vital Signs MonitorRudolf Riester GmbH Oct 17, 2017
K172179 — Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd. Oct 17, 2017
K171752 — X-SURGEGenicon, Inc. Oct 17, 2017
K172493 — EnsoETMAttune Medical Oct 17, 2017
K160282 — SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home SystemSd Biosensor Oct 17, 2017
K170834 — CERABIEN ZRKuraray Noritake Dental, Inc. Oct 17, 2017
K172817 — 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EAOlympus Medical Systems Corp. Oct 17, 2017
K171879 — HylaGuard Moisturizing CreamFounders Science Group, LLC Oct 16, 2017
K172537 — Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagCodman & Shurtleff, Inc. Oct 16, 2017
K172487 — Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp. Oct 16, 2017
K170819 — AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc. Oct 16, 2017
K170948 — AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. Oct 16, 2017
K162042 — OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp. Oct 16, 2017
K171974 — Solana RSV+hMPV AssayQuidel Corporation Oct 16, 2017
K172186 — BioWick X Implant with DriverCayenne Medical, Inc. Oct 16, 2017
K170151 — Electronic Blood Pressure MonitorShenzhen Pango Electronic Co., Ltd. Oct 13, 2017
K172772 — Freemie Independence, Freemie LibertyDao Health Oct 13, 2017
K170241 — GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring SystemAll Medicus Co., Ltd. Oct 13, 2017
K172435 — Galaxy R Digital Radiography UpgradeMedien International Co, Ltd. Oct 13, 2017
K170232 — AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerBoditech Med, Inc. Oct 13, 2017
K172498 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4YMicrolife Intellectual Property GmbH Oct 13, 2017
K170233 — Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)Zhanjiang Star Enterprise Co., Ltd. Oct 13, 2017
K162362 — PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical IndicatorPms Tibbi Cihazlar Teknolojisi San VE Tic AS Oct 13, 2017
K171015 — CitryteDi-Chem, Inc. Oct 13, 2017
K172181 — micro IPLEl Global Trade, Ltd. Oct 13, 2017
K163277 — SuperNO2VA DeviceRevolutionary Medical Devices, Inc. Oct 13, 2017
K171548 — Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. Oct 13, 2017
K172023 — CELFIRMVIOL Co., Ltd. Oct 13, 2017
K172454 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mLThermo Fisher Scientific Oct 13, 2017
K171120 — Senhance Surgical Robotic SystemTransenterix, Inc. Oct 13, 2017
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