510(k) Clearances in 2017 — Page 51

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 51 of 64)
510(k) clearancesDetails
K170476 — Nio Color 5.8MP (MDNC-6121)Barco N.V. Mar 28, 2017
K162405 — Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)Comfort Rubber Gloves Industries Sdn. Bhd. Mar 28, 2017
K162789 — Foresight Intracardiac Echocardiology (ICE) SystemConavi Medical, Inc. Mar 28, 2017
K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. Mar 28, 2017
K170493 — HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Mar 28, 2017
K163248 — Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration NeedleBoston Scientific Corporation Mar 27, 2017
K161812 — Freedom SyringeProcedure Products, Inc. Mar 27, 2017
DEN160028 — ipsogen JAK2 RGQ PCR KitQiagen, Inc. Mar 27, 2017
K161667 — Sapphire Infusion PumpQ Core Medical , Ltd. Mar 27, 2017
K161731 — Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp. Mar 27, 2017
K162784 — Silk'n HSTHome Skinovations , Ltd. Mar 25, 2017
K162503 — Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView SoftwareCardiac Insight, Inc. Mar 24, 2017
K170701 — GEN_2 and GEN_3 Mechanical WheelchairsFree Wheelchair Mission Mar 24, 2017
K170204 — FFR Link, FFR Signal Processing ModuleBoston Scientific Corporation Mar 24, 2017
K163267 — NITRILE EXAMINATION GLOVEBrightway Holdings Sdn. Bhd. Mar 24, 2017
K162850 — GuideMia Ortho+Guidemia Technologies, LLC Mar 24, 2017
K162701 — VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation Mar 24, 2017
K162342 — Stellaris Elite Vision Enhancement SystemBausch+Lomb Mar 24, 2017
K162979 — Veloxion SystemCorinth Medtech, Inc. Mar 24, 2017
K163249 — GoSpiroMonitored Therapeutics, Inc. Mar 24, 2017
K162023 — CardioDay V2.5Getemed Medizin- Und Informationstechnik AG Mar 24, 2017
K162235 — LUVENA VAGINAL MOISTURIZER & LUBRICANTLaclede, Inc. Mar 24, 2017
K161835 — iovera systemMyoscience, Inc. Mar 24, 2017
K160581 — K3PRO Konus Additional Abutments and ImplantsArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG Mar 24, 2017
K162967 — nuance UNIVERSALDen-Mat Holdings, LLC Mar 24, 2017
K163290 — INFINITT ULiteInfinitt Co., Ltd. Mar 24, 2017
K170335 — Custom Stable(TM) Rigid Gas Permeable Scleral Contact LensValley Contax, Inc. Mar 24, 2017
K162556 — LIGHTFUSION LED SYSTEMVitage Led, Ltd. Mar 24, 2017
K162028 — PREMIUM - SHELTA Prosthetic ComponentsSweden & Martina S.P.A. Mar 24, 2017
K163297 — Scan&GOSiemens Medical Solutions USA, Inc. Mar 24, 2017
K162615 — Mould Applicator SetVarian Medical Systems, Inc. Mar 24, 2017
K163587 — VERIFY Incubator for Assert Self Contained Biological IndicatorsSTERIS Corporation Mar 24, 2017
K163425 — NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating SystemNarang Medical USA Corporation Mar 24, 2017
K170329 — Basic, Dominant FlexModela AG Mar 24, 2017
K163491 — NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated Mar 24, 2017
K161680 — MEDICON Spinal Spreading SystemsMedicon EG Mar 24, 2017
K161428 — PerfectSmoothShen Zhen Cosbeauty Co., Ltd. Mar 23, 2017
K163182 — Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System AccessoriesMedtronic Powered Surgical Solutions Mar 23, 2017
K163558 — Synapsys Ulmer Video NystagmographSynapsys SA Mar 23, 2017
K163314 — Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension CatheterBoston Scientific Corporation Mar 23, 2017
K163103 — Tranberg CLS Diffusor Laser FiberClinical Laserthermia Systems, AB Mar 23, 2017
K162217 — LOYONOculus Innovative Sciences Mar 23, 2017
K170277 — DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Mar 23, 2017
K162037 — Eclipse with VEMPInteracoustics A/S Mar 23, 2017
K163109 — OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc. Mar 22, 2017
K163099 — My Dose CoachSanofi, Inc. Mar 22, 2017
K170520 — HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+Alcon Research, Ltd. Mar 22, 2017
K163300 — ThermoShield HME FilterFlexicare Medical Limited. Mar 22, 2017
K161979 — ENFit enteral syringeJiangyin Caina Technology Co., Ltd. Mar 22, 2017
K161141 — ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFITPentaferte Italia S.R.L. Mar 22, 2017
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