510(k) Clearances in 2019 — Page 19

2,918 510(k) clearances total

Browse FDA 510(k) clearances granted in 2019. RegDataLab tracks 2,918 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2019 (page 19 of 59)
510(k) clearancesDetails
K191947 — VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return CordMaquet Cardiovascular, LLC Sep 17, 2019
K190049 — Sim&SizeSim&Cure Sep 17, 2019
K191929 — UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensUnicon Optical Co., Ltd. Sep 17, 2019
K183708 — Poly ClearMedtek Skincare, LLC Sep 17, 2019
K191800 — Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling ClaimKossan International Sdn Bhd Sep 16, 2019
K191676 — Intra.Ox 2.0 Handheld Tissue OximeterVioptix, Inc. Sep 16, 2019
K190708 — AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. Sep 16, 2019
K191688 — SubtleMRSubtle Medical, Inc. Sep 16, 2019
K191576 — Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc. Sep 16, 2019
K191641 — AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius ScrewsIndustrias Medicas Sampedro S.A.S Sep 16, 2019
K190507 — Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd. Sep 16, 2019
K191685 — PicoWay Laser SystemCandela Corporation Sep 16, 2019
K191378 — 0.9% Sodium Chloride Injection, USP, Pre-filled COP SyringeMedline Industries, Inc. Sep 15, 2019
K183586 — CapMedicCognita Labs, LLC Sep 13, 2019
K191599 — NICO Myriad NOVUSNico Corporation Sep 13, 2019
K183670 — Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact LensVisco Vision, Inc. Sep 13, 2019
K190473 — ACIST RXi System and Navvus II CatheterAcist Medical Systems, Inc. Sep 13, 2019
K190005 — Sterilucent HC 80TT Hydrogen Peroxide SterilizerSterilucent, Inc. Sep 13, 2019
K190830 — TDM Screw SystemsTdm Co., Ltd. Sep 13, 2019
K181478 — Roosin Xeroform Petrolatum DressingRoosin Medical Co., Ltd. Sep 13, 2019
K190288 — Arthrex Tenodesis ButtonArthrex, Inc. Sep 13, 2019
K182921 — Infinix Universal CompositeNobio , Ltd. Sep 13, 2019
K183364 — BellavistaImtmedical AG Sep 13, 2019
K191273 — Multi-Link X2 ECG and SpO2 AdapterVyaire Medical, Inc. Sep 13, 2019
K191459 — JuggerStitch Meniscal Repair DeviceBiomet, Inc. Sep 13, 2019
K191801 — PROBEAT-CRHitachi , Ltd. Sep 13, 2019
K192304 — SIS Software Version 3.6.0Surgical Information Sciences, Inc. Sep 13, 2019
K190869 — Pulse OximeterShenzhen Aeon Technology Co., Ltd. Sep 13, 2019
K190841 — SCENARIA ViewHitachi Healthcare Americas Sep 13, 2019
K191949 — UNFOLDER Vitan InserterJohnson & Johnson Surgical Vision, Inc. Sep 13, 2019
K192217 — NCB Plating System Distal Femur and Proximal TibiaZimmer GmbH Sep 13, 2019
K191595 — ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division Sep 13, 2019
K191021 — Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene ChemdyeTerragene S.A. Sep 13, 2019
K190932 — RFID Localization SystemHealth Beacons, Inc. Sep 13, 2019
K191629 — faceLITEIsmart Marketing Svcs, Ltd. Sep 12, 2019
K192199 — CRC PC Smart Chamber K1Capintec, Inc. Sep 12, 2019
K191148 — Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc. Sep 12, 2019
K191587 — L360 Thigh SystemBioness, Inc. Sep 12, 2019
K191419 — Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy GuidewireRex Medical, L.P. Sep 12, 2019
K183695 — OrthoAnalysis SoftwareInteware Co., Ltd. Sep 12, 2019
K192012 — Capillus 112, Capillus 244Capillus Sep 12, 2019
K190398 — Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC Sep 12, 2019
K191518 — CO2 Laser SystemShenzhen Gsd Tech Co., Ltd. Sep 12, 2019
K191516 — Ali Interbody Fusion SystemRaed M. Ali, M.D., Inc. Sep 12, 2019
K183662 — Saline Wound Wash, SteriCleanse(TM)Ascent Consumer Products, Inc. Sep 12, 2019
K191300 — MectaLock Ti Suture AnchorMedacta International S.A. Sep 12, 2019
K191726 — mont blanc & mont blanc MIS Spinal SystemsSpineway SA Sep 12, 2019
K190780 — syngo Application SoftwareSiemens Medical Solution USA, Inc. Sep 12, 2019
K190768 — ARTIS iconoSiemens Medical Solutions USA, Inc. Sep 12, 2019
K190002 — Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single useShanghai Kohope Medical Devices Co., Ltd. Sep 12, 2019
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