510(k) Clearances in 2017 — Page 4

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 4 of 64)
510(k) clearancesDetails
K172932 — True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc. Dec 13, 2017
K171167 — Prodigio Stain PowderOperart, LLC Dec 13, 2017
K172651 — FMP Extended LinersEncore Medical L.P. Dec 13, 2017
K173002 — 2940 nm Er:Yag Laser HandpieceQuanta System Spa Dec 13, 2017
K172056 — InnoSight Diagnostic Ultrasound SystemQisda Corporation Dec 13, 2017
K172692 — Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact LensTangible Science, LLC Dec 13, 2017
K173369 — DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. Dec 13, 2017
K172217 — Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated Dec 13, 2017
K173502 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc. Dec 13, 2017
K171729 — Fixtemp C&BDreve Dentamid GmbH Dec 13, 2017
K172052 — Arthrex DynaNite Nitinol StapleArthrex, Inc. Dec 13, 2017
K171058 — Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A. Dec 13, 2017
K171381 — Adhesive ElectrodesShenzhen Quality Medical Technology Co.,Ltd Dec 13, 2017
K173374 — TSV BellaTek Encode Healing AbutmentsBiomet 3I Dec 13, 2017
K171781 — eVox SystemEvoke Neuroscience, Inc. Dec 13, 2017
K173441 — Neurosoft TMS (also CloudTMS)Teleemg, LLC Dec 13, 2017
K173524 — ANAX 5.5™ Spinal SystemU&I Corporation Dec 13, 2017
K171480 — NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemI-Sens, Inc. Dec 13, 2017
K173621 — Advocate PTA CatheterMerit Medical Systems, Inc. Dec 13, 2017
K172432 — SporView Rapid Read Biological IndicatorCrosstex/Spsmedical, A Division Of Cantel Medical Dec 12, 2017
K172276 — Xario 200 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation Dec 12, 2017
K173137 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)Hartalega Sdn Bhd Dec 12, 2017
K170898 — Wittich Nitinol Stone BasketCook Incorporated Dec 12, 2017
K171956 — Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd. Dec 12, 2017
K173467 — Advanced Diffusion Analysis (ADA) applicationPhilips Medical Systems Nederland B.V. Dec 12, 2017
K170279 — Disposable High Pressure SyringeUnion Medical Shenzhen Co., Ltd. Dec 12, 2017
K170988 — DropSafe Safety Pen NeedleHtl-Strefa S.A Dec 12, 2017
K173392 — Pure-Vu SystemMotus GI Medical Technologies , Ltd. Dec 12, 2017
K172737 — MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited Dec 12, 2017
K173536 — T2Candida 1.1 PanelT2Biosystems, Inc. Dec 12, 2017
K173480 — Crystalsert Lens Delivery SystemBausch & Lomb, Inc. Dec 11, 2017
K173484 — CorticaLINK Spinal Fusion PlatformLinkspine, Inc. Dec 11, 2017
K172405 — SNIPER STAPLE SYSTEM, NON-STERILETrilliant Surgical Dec 11, 2017
K170276 — Safety Blood Collection Device for Single UseGemtier Medical (Shanghai), Inc. Dec 11, 2017
K173612 — Optima XR646 HDGe Hualun Medical Systems Co. , Ltd. Dec 11, 2017
K172722 — Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)Euroimmun Us, Inc. Dec 10, 2017
K172713 — Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators setFujirebio Diagnostics,Inc. Dec 10, 2017
K171677 — Clear Guide SCENERGYClear Guide Medical Dec 8, 2017
K172714 — LipiVageGenesis Biosystems, Inc. Dec 8, 2017
K172786 — MDS Plating SystemMiami Device Solutions, LLC Dec 8, 2017
K172445 — RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. Dec 8, 2017
K173462 — Wireless Pain Relieve Device Model: LT5018CShenzhen Dongdixin Technology Co., Ltd. Dec 8, 2017
K171186 — Cerebrotech CMS-5000Cerebrotech Medical Systems Dec 8, 2017
K171928 — Med-Hot Thermal Imaging SystemsMed-Hot Thermal Imaging, Inc. Dec 8, 2017
K172302 — InMode PLUS SystemInmode MD , Ltd. Dec 8, 2017
K173475 — Merge PACSMerge Healthcare Incorporated Dec 8, 2017
K172756 — Varian cageMedyssey USA, Inc. Dec 8, 2017
K172222 — 8ch Flex SuiteShenzhen RF Tech Co., Ltd. Dec 8, 2017
K171553 — W&H Assistina TwinW&H Dentalwerk Buermoos GmbH Dec 8, 2017
K172966 — CMS-2000 Central Monitoring SystemAdvanced Instumentations, Inc. Dec 8, 2017
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