510(k) Clearances in 2017 — Page 31

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 31 of 64)
510(k) clearancesDetails
K170407 — BD ChloraShield IV Dressing with CHG AntimicrobialAvery Dennison Belgie Bvba Jul 17, 2017
K162957 — U2 Femoral HeadUnited Orthopedic Corporation Jul 17, 2017
K171404 — BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated Jul 17, 2017
K171115 — 3D Endo SoftwareDentsply Sirona Jul 17, 2017
K170607 — !M1Solutions For Tomorrow AB Jul 17, 2017
K162153 — Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics Jul 14, 2017
K170710 — True Spinal Fixation SystemInnovative Surgical Designs, Inc. Jul 14, 2017
K171907 — Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc. Jul 14, 2017
K170798 — Dictum HealthDictum Health, Inc. Jul 14, 2017
K171522 — truFreeze Rapid AV Spray KitCSA Medical, Inc. Jul 14, 2017
K171539 — Contact Lens CaseE-Link Plastic & Metal Industrial Co.,Ltd Jul 14, 2017
K162803 — Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular GraftsVascutek, Ltd. Jul 14, 2017
K171029 — eCareCoordinatorVisicu, Inc. Jul 14, 2017
K170757 — Aegis Transit SystemBoston-Biomedical Associates Jul 14, 2017
K163318 — Soules Intrauterine Insemination CatheterCook Incorporated Jul 14, 2017
K160712 — VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics Jul 14, 2017
K171413 — HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc. Jul 14, 2017
K171242 — Alma LipoFlow SystemAlma Lasers, Inc. Jul 14, 2017
K170686 — Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy DrugsBrightway Holdings Sdn. Bhd. Jul 14, 2017
K170518 — In2Bones Fracture and Correction SystemIn2Bones USA, LLC Jul 14, 2017
K163194 — Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. Jul 14, 2017
K171128 — SIGNA PremierGe Medical Systems, LLC Jul 14, 2017
K162707 — Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and ReloadGolden Stapler Surgical Co., Ltd. Jul 14, 2017
K163150 — ViMove2Dorsavi, Ltd. Jul 14, 2017
K170637 — sensiFirmEl Global Trade, Ltd. Jul 14, 2017
K162853 — Bonafix TWO - Dental Implant SystemBonafix Surgical And Dental Implants Jul 14, 2017
K170090 — RTHawk, HeartVista Cardiac PackageHeartvista, Inc. Jul 14, 2017
K162698 — MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd. Jul 14, 2017
K171747 — MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery SystemCodman & Shurtleff, Inc. Jul 14, 2017
K170676 — HD Lumbar Interbody SystemHd Lifesciences, LLC Jul 13, 2017
K162815 — SterilContainer S SystemAesculap, Inc. Jul 13, 2017
K170660 — Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. Jul 13, 2017
K171656 — Genesys Spine Apache Interbody Fusion SystemGenesys Spine Jul 13, 2017
K171749 — Velofix(tm) Interbody Fusion SystemU&I Corporation Jul 13, 2017
K170550 — Coveris Cervical Cage SystemCamber Spine Technologies Jul 13, 2017
K170986 — KATANA Zirconia BlockKuraray Noritake Dental, Inc. Jul 13, 2017
K171018 — Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC Jul 13, 2017
K170808 — Unity Total Knee SystemCorin U.S.A. Limited Jul 13, 2017
K171813 — OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd. Jul 13, 2017
K162878 — Kitazato ET CathetersKitazato Corporation Jul 13, 2017
K170999 — P50 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp. Jul 12, 2017
K171733 — TrueBeam, TrueBeam STx, EdgeVarian Medical Systems, Inc. Jul 12, 2017
K170318 — NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC Jul 12, 2017
K163560 — Reprocessed AcuNav Diagnostic Ultrasound CatheterInnovative Health, LLC Jul 12, 2017
K163571 — Great Basin Stool Bacterial Pathogens PanelGreat Basin Scientific, Inc. Jul 12, 2017
K170507 — Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low MaxxInvacare Corporation Jul 12, 2017
K171766 — Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. Jul 12, 2017
K163057 — RelizorbAlcresta Therapeutics, Inc. Jul 12, 2017
K170435 — NerveGuard NRFit, NerveGuard LUERPAJUNK GmbH Medizintechnologie Jul 12, 2017
K163504 — Borrelia B31 ViraChip IgG Test KitViramed Biotech AG Jul 12, 2017
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