510(k) Clearances in 2017 — Page 52

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 52 of 64)
510(k) clearancesDetails
K170530 — Butrex Lumbar Buttress Plating SystemX-Spine Systems, Inc. Mar 22, 2017
K170636 — Fathom-16 Steerable GuidewiresBoston Scientific Corporation Mar 22, 2017
K163017 — Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy DrugsGmp Medicare Sdn. Bhd. Mar 22, 2017
K163320 — LAP-Pump PP110W.O.M. World Of Medicine GmbH Mar 21, 2017
K162740 — MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)Beckman Coulter, Inc. Mar 21, 2017
K163296 — SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc. Mar 21, 2017
K163405 — 360KS Implant Positioning SystemKico Knee Innovation Company Pty Limited Mar 21, 2017
K163608 — HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mmBiostable Science & Engineering, Inc. Mar 21, 2017
K163343 — Icare HOME tonometerIcare Finland OY Mar 21, 2017
K163637 — BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)Becton Dickinson & Company Mar 21, 2017
K162758 — VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge PackSTERIS Corporation Mar 21, 2017
K163157 — SmartGridCarestream Health Mar 21, 2017
K163401 — Nix Ultra Lice Treatment KitMedtech Products, Inc. Mar 21, 2017
K152534 — Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. Mar 21, 2017
K170296 — CoreCath 2.7SMedtronic Advanced Energy Mar 20, 2017
K163161 — Sterile Single-use Syringe with NeedleJiangxi Hongda Medical Equipment Group , Ltd. Mar 20, 2017
K160139 — Luggie ChairFreerider Corporation Mar 20, 2017
K163488 — Flex-Thread Clavicle Pin SystemIntrafuse, LLC Mar 20, 2017
K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding SystemsTedan Surgical Innovations, LLC Mar 20, 2017
K163175 — Bel-Cypher ProTakara Belmont Corporation Mar 20, 2017
K161691 — Direct LDL Cholesterol (LDL)Randox Laboratories Limited Mar 20, 2017
K163323 — Dolphix® External Fixation System MR ConditionalCitieffe S.R.L. Mar 20, 2017
K163162 — Sterile Hypodermic Safety Syringes for Single UseJiangxi Hongda Medical Equipment Group , Ltd. Mar 20, 2017
K170539 — Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mmAvitus Orthopaedics, Inc. Mar 20, 2017
K162308 — Noris Medical MBI-2mm Dental Implant SystemNoris Medical , Ltd. Mar 17, 2017
K161250 — OC-FLEX Flexible IntraOral CannulaVenture Therapeutics, Inc. Mar 17, 2017
K170501 — CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation Mar 17, 2017
K163378 — Monarch Airway Clearance SystemHill-Rom Services Pte, Ltd. Mar 17, 2017
K162522 — UltraCath Continuous Nerve block CatheterTeleflexmedical, Inc. Mar 17, 2017
K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. Mar 17, 2017
K163239 — SMARTmaticKaltenbach & Voigt GmbH Mar 17, 2017
K163331 — Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA ArtistGe Medical Systems, LLC Mar 17, 2017
K161077 — RnD TE and RnD SEApex Dental Materials, Inc. Mar 17, 2017
K162562 — OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMYBcg Medical, LLC Mar 17, 2017
K163586 — Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit ConnectorTrovrx, Inc. Dba Trovita Health Science Mar 17, 2017
K163569 — Elecsys CMV IgMRoche Diagnostics Mar 17, 2017
K162898 — Olecranon Plating SystemMiami Device Solutions, LLC Mar 17, 2017
K163346 — MAZIC DuroVericom Co., Ltd. Mar 17, 2017
K163655 — SparklingShanghai Wonderful Opto-Electrics Tech.Co.,Ltd Mar 17, 2017
K153600 — Consult Station TSH4D Sas Mar 17, 2017
K162868 — Exam Vue PACSJpi Healthcare Solutions, Inc. Mar 17, 2017
K163201 — KYMCO EQ10D ScooterKwang Yang Motor Co., Ltd. Mar 16, 2017
K163230 — NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated Mar 16, 2017
K161840 — LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coatedWaldemar Link GmbH & Co. KG Mar 16, 2017
K170455 — MectaLIF Anterior Stand AloneMedacta International S.A. Mar 16, 2017
K162313 — NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated Mar 16, 2017
K163082 — 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.P.A. Mar 16, 2017
K163003 — Y3 Proximal Femoral Plate SystemPega Medical, Inc. Mar 16, 2017
K161705 — U2 Total Knee System E-XPE productsUnited Orthopedic Corporation Mar 16, 2017
K162880 — TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc. Mar 16, 2017
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