510(k) Clearances in 2023 — Page 50

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 50 of 67)
510(k) clearancesDetails
K230749 — TriMed Threaded Intramedullary Nail SystemTriMed, Inc. Apr 17, 2023
K222829 — Curian® Shiga ToxinMeridian Bioscience, Inc. Apr 17, 2023
K223564 — X-CUBE 50, X-CUBE 60Alpinion Medical Systems Co., Ltd. Apr 17, 2023
DEN220059 — NTX100 Tonic Motor Activation (NTX100 ToMAc) SystemNoctrix Health, Inc. Apr 17, 2023
K223577 — Localite TMS Navigator TSLocalite GmbH Apr 17, 2023
K223454 — Custom-made Invisible AlignersZhejiang Yinchili Medical Technology Co., Ltd. Apr 17, 2023
K230544 — SnugFit All-Suture Anchor extensionMedacta International S.A. Apr 17, 2023
K221974 — EpiFinderOmeq Medical , Ltd. Apr 16, 2023
K213676 — Masimo Rad-G with TemperatureMasimo Corporation Apr 16, 2023
K222066 — LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG Apr 14, 2023
K223785 — N9+Nonagon , Ltd. Apr 14, 2023
K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)Plasmapp Co,., Ltd. Apr 14, 2023
K221865 — BTL-094BTL Industries, Inc. Apr 14, 2023
K230685 — AutoContour Model RADAC V3Radformation, Inc. Apr 14, 2023
K223018 — OSPREY PERIPHERAL IV Catheter SystemSkydance Vascular, Inc. Apr 14, 2023
K223705 — EndoflipTM 300Covidien, LLC Apr 14, 2023
K223509 — Compremium Compartment Compressibility Monitoring System (CPM#1)Compremium AG Apr 14, 2023
K230411 — Dragonfly OpStar™ Imaging CatheterABBOTT MEDICAL Apr 14, 2023
K223566 — ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc. Apr 14, 2023
K220854 — TrachCuff Cuff ControllerAw Technologies Aps Apr 14, 2023
K230868 — SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative ControlMaine Molecular Quality Controls, Inc. Apr 13, 2023
K222185 — Stratus Infusion CatheterIntervene, Inc. Apr 13, 2023
K230010 — ADSEAL PlusMeta Biomed Co., Ltd. Apr 13, 2023
K230694 — NaviCam Xpress Stomach System, NaviCam Xpress SystemAnx Robotica Corp Apr 13, 2023
K193514 — AUTION MAX AX-4060 Urinalysis SystemArkray, Inc. Apr 13, 2023
K230143 — DESS Dental Smart SolutionsTerrats Medical SL Apr 13, 2023
K223435 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. Apr 13, 2023
K220763 — ALPCO Calprotectin Immunoturbidimetric AssayALPCO Apr 13, 2023
K222350 — Sterile Nitrile Surgical Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. Apr 13, 2023
K222200 — CIRRUS HD-OCTCarl Zeiss Meditec, Inc. Apr 13, 2023
K230719 — BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC Apr 13, 2023
K230264 — Ezra FlashEzra Ai, Inc. Apr 13, 2023
K223879 — Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L. Apr 13, 2023
K230387 — ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S)Ethicon Endo-Surgery, LLC Apr 13, 2023
K230393 — UniCam Evo SoftwareInter Medical Medizintechnik GmbH Apr 13, 2023
K213986 — CerebralGo PlusYukun (Beijing) Technology Co., Ltd. Apr 13, 2023
K230412 — Symmed Elite AestheticTermosalud Apr 13, 2023
K230098 — Trusana™Myerson, LLC Apr 13, 2023
K222738 — Point implant systemPointnix Co., Ltd. Apr 13, 2023
K230424 — Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate SystemOmnia Medical, LLC Apr 12, 2023
K223838 — Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC Apr 12, 2023
K220312 — Polyfusion IV Administration SetsPoly Medicure Limited Apr 12, 2023
K223332 — Task Force CORECnsystems Medizintechnik GmbH Apr 12, 2023
K222781 — AugmentoDeeptek Medical Imaging Private Limited Apr 11, 2023
K230732 — Eagle S/Saevo Slim/D700 SlimAlliage S/A Industrias Medica Odontológico. Apr 11, 2023
K221303 — Neuspera Nuity SystemNeuspera Medical, Inc. Apr 11, 2023
K223530 — Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. Apr 11, 2023
K230754 — L12 LED Light Source with AIMStryker Apr 11, 2023
K223830 — Ultrasound System 2300Bk Medical Aps Apr 11, 2023
K222910 — Bronchoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd. Apr 11, 2023
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