510(k) Clearances in 2023 — Page 64

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 64 of 67)
510(k) clearancesDetails
K210112 — XChange Device, XChange SystemPneuma Therapeutics, Inc. Jan 30, 2023
K221532 — PHMB Wound DressingWinner Medical Co., Ltd. Jan 30, 2023
K222567 — Playground For All Love SeshPlayground For All Jan 30, 2023
K223348 — My3D® Personalized Pelvic ReconstructionOnkos Surgical, Inc. Jan 30, 2023
K212684 — BrainView QEEG SoftwareMedeia, Inc. Jan 28, 2023
K210166 — Omnispec ED1000Medispec, Ltd. Jan 27, 2023
K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd Jan 27, 2023
K223546 — 14HQ721G-BLg Electronics.Inc Jan 27, 2023
K223903 — Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)Semperit Investments Asia Pte , Ltd. Jan 27, 2023
K222835 — Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc Jan 27, 2023
K221338 — F&P Airvo 3Fisher & Paykel Healthcare Jan 27, 2023
K221551 — FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton Jan 27, 2023
K220803 — VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP MoxifloxacinbioMerieux, Inc. Jan 27, 2023
K213059 — Tibia and Fibula SystemAuxein Medical Private Limited Jan 27, 2023
K222664 — Sim&SizeSim&Cure Jan 27, 2023
K221868 — QOCA image Smart CXR Image Processing SystemQuanta Computer, Inc. Jan 27, 2023
K223090 — GEM Premier ChemSTATInstrumentation Laboratory CO Jan 27, 2023
K203833 — Tacrolimus Assay KitShanghai Genext Medical Technology Co., Ltd. Jan 27, 2023
K211559 — EasyStat 300Medica Corporation Jan 27, 2023
K223254 — C2 XploreInomed Medizintechnik GmbH Jan 27, 2023
K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and AccessoriesGyrus Acmi, Inc. Jan 27, 2023
K222901 — EVA15 insufflatorPalliare , Ltd. Jan 27, 2023
K223927 — 360CASKico Knee Innovation Company Pty Limited Jan 27, 2023
K221949 — Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemPausch Medical GmbH Jan 26, 2023
K221424 — Sterile Surgical Powder Free Latex GloveNew Era Medicare Sdn. Bhd. Jan 26, 2023
K220073 — RMF-2000DRTECH Corporation Jan 26, 2023
K221619 — ECHELON Oval V6.2 MRI SystemFujifilm Healthcare Corporation Jan 26, 2023
K222779 — RevogeneMeridian Bioscience, Inc. Jan 26, 2023
K222589 — Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc. Jan 26, 2023
K223588 — PALLAS PremiumLaseroptek Co., Ltd. Jan 26, 2023
K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeHowmedica Osteonics Corp., Dba Stryker Orthopaedics Jan 26, 2023
K223415 — Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl CitrateMah Sing Healthcare Sdn. Bhd. Jan 26, 2023
K222437 — Aristotle Colossus GuidewireScientia Vascular, Inc. Jan 26, 2023
K222403 — Surgical GownGuangzhou Fuzelong Hygiene Material Co., Ltd. Jan 26, 2023
K222801 — Safety LancetSarstedt AG & CO KG Jan 25, 2023
K223306 — SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc. Jan 25, 2023
K221150 — Advanced Bone PlateDouble Medical Technology, Inc. Jan 25, 2023
K223563 — OsteoCNXConverg Engineering Jan 25, 2023
K223866 — Carevix™ Suction Cervical StabilizerAspivix SA Jan 25, 2023
K223847 — CREED™ Cannulated ScrewsGlw, Inc. Jan 25, 2023
K220114 — PowerPAK SyringeVault Paragon Group, Inc. Jan 25, 2023
K223314 — Disposable Blood LancetsHuaian Hening Medical Instruments Co., Ltd. Jan 25, 2023
K222665 — Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc. Jan 25, 2023
K222818 — Xpedition ™ Powered Stair Chair (625700000000)Stryker Medical Jan 24, 2023
K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)Wuxi Jiajian Medical Instrument Co., Ltd. Jan 24, 2023
K222406 — Clarius AIClarius Mobile Health Corp. Jan 23, 2023
K203689 — Tidepool LoopTidepool Project Jan 23, 2023
K223494 — CD Horizon Spinal SystemMedtronic Jan 23, 2023
K221494 — Quality Mix Blender, OxymixerDehas Medical Systems GmbH Jan 23, 2023
K223313 — Disposable Safety LancetsHuaian Hening Medical Instruments Co., Ltd. Jan 23, 2023
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