510(k) Clearances in 2017 — Page 21

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 21 of 64)
510(k) clearancesDetails
K172481 — IntelliCart SystemDornoch Medical Systems Sep 14, 2017
K170168 — Masimo Rad-97 and AccessoriesMasimo Corporation Sep 14, 2017
DEN160018 — reSetPear Therapeutics, Inc. Sep 14, 2017
K171953 — Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. Sep 14, 2017
K171832 — Range/Denali/Mesa Spinal SystemK2M, Inc. Sep 14, 2017
K171051 — HORIZON Therapy SystemMagstim Company, Ltd. Sep 13, 2017
K171201 — NeuViz Prime Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. Sep 13, 2017
K171359 — Pollogen Legend+ SystemPollogen, Ltd. Sep 13, 2017
K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc. Sep 13, 2017
K172142 — FibroScan 430 Mini+Echosens Sep 13, 2017
K163215 — AnemoCheckSanguina, LLC Sep 13, 2017
K170185 — tremoFlo C-100 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc. Sep 12, 2017
K171537 — CAPI 3 Hb A1cSebia Sep 12, 2017
K171582 — NEO Pedicle Screw System™Neo Medical SA Sep 12, 2017
K171144 — Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 BevelMedbio, LLC Sep 12, 2017
K170875 — da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. Sep 12, 2017
K171770 — cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. Sep 12, 2017
K171233 — Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. Sep 12, 2017
K170409 — PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemTopcon Medical Laser Systems, Inc. (Tmls) Sep 12, 2017
K170644 — da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)Intuitive Surgical, Inc. Sep 11, 2017
K170275 — Tri Auto ZX2J. Morita USA, Inc. Sep 11, 2017
K171317 — Clear Vinyl Powder-free Patient Examination GlovesShandong Zhi Hong Medical Products, Co. , Ltd. Sep 11, 2017
K170822 — Electronic Caries DetectorOrtek Therapeutics, Inc. Sep 11, 2017
K171067 — INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc Sep 11, 2017
K172117 — Prelude Pursuit Splittable Sheath IntroducerMerit Medical Systems, Inc. Sep 11, 2017
K170487 — Navina Classic SystemDentsply Sirona Sep 11, 2017
K170596 — TN-BrushGenoss Co., Ltd. Sep 11, 2017
K170368 — Sterile NS SystemJeil Medical Corporation Sep 11, 2017
K171189 — AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.A Sep 11, 2017
K170645 — da Vinci Xi EndoWrist Instruments and AccessoriesIntuitive Surgical, Inc. Sep 11, 2017
K171531 — Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration NeedleCare Fusion Sep 11, 2017
K170047 — All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd. Sep 9, 2017
K171648 — BM.IRISBluecore Co., Ltd. Sep 8, 2017
K163292 — Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block CrawfordSpectra Medical Devices Sep 8, 2017
K171351 — Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc. Sep 8, 2017
K171334 — IndegoParker Hannifin Corporation Sep 8, 2017
K171251 — 014 Hydrophilic Coated PTA Balloon Dilatation CatheterCreagh Medical Sep 8, 2017
K171725 — CuffLink Implant SystemConmed Corporation Sep 8, 2017
K170415 — Medline Hemo-Force DVT Compression SleeveMedline Industries, Inc. Sep 8, 2017
K170704 — The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc. Sep 8, 2017
K170032 — QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV Sep 8, 2017
K171510 — Footmotion Plating SystemNewclip Technics Sep 8, 2017
K171893 — Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)Bluestone Synergy Sep 8, 2017
K163699 — ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with HookAln Implants Chirurgicaux Sep 8, 2017
K172170 — APTUS(R) Wrist 2.5 SystemMedartis AG Sep 8, 2017
K163710 — BePOD® EZ Weil ScrewsFournitures Hospitalieres Industrie Sep 8, 2017
K171805 — Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 mlConceptomed AS Sep 8, 2017
K171667 — Powder Free Nitrile Examination GloveProfessional Latex Sdn Bhd Sep 8, 2017
K171330 — Nanova SealantNanova Biomaterials, Inc. Sep 8, 2017
K163465 — hemochroma PLUS SystemImmunostics Inc., Sep 8, 2017
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