510(k) Clearances in 2023 — Page 34

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 34 of 67)
510(k) clearancesDetails
K230462 — OPTIX H2 Patient Specific Instrument SystemVilex, LLC Jul 17, 2023
K231460 — FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate SystemK&J Consulting Corp. Jul 16, 2023
K231841 — PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd. Jul 14, 2023
K231041 — JiveX (Model Number / Release: 5.4)Visus Health IT GmbH Jul 14, 2023
K223173 — Proxeo ULTRA (PB-510, PB-520 and PB-530)W&H Dentalwerk Buermoss GmbH Jul 14, 2023
K231782 — FlowSaver Blood Return System (80-101)Inari Medical, Inc. Jul 14, 2023
K230016 — Cercare Medical NeurosuiteCercare Medical A/S Jul 14, 2023
K223886 — Wearable Breast Pump (Model S18)Shenzhen TPH Technology Co., Ltd. Jul 14, 2023
K231392 — NaviNetics Reusable Stereotactic System (NN1000)Navinetics, Inc. Jul 14, 2023
DEN230012 — Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine Jul 14, 2023
K230269 — Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation Jul 14, 2023
K222026 — Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. Jul 14, 2023
K223106 — Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)Brainlab AG Jul 14, 2023
K231428 — Mobility Scooter (Models: W3431D)Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Jul 14, 2023
K220282 — i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott Laboratories Jul 14, 2023
K230445 — OnX ToughSprintray, Inc. Jul 14, 2023
K221673 — Bonafix TiBaseZentek Medical, LLC Jul 14, 2023
K231757 — Ez3D-i /E3Ewoosoft Co., Ltd. Jul 14, 2023
K223290 — CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)Sentiar, Inc. Jul 14, 2023
K223791 — TalWireEmbrace Medical , Ltd. Jul 14, 2023
K223424 — Spine Auto ViewsGE Medical Systems SCS Jul 13, 2023
K223125 — XR90 (XR90-SYS)Mediview Xr, Inc. Jul 13, 2023
K221961 — HydroMARK Plus Breast Biopsy Site MarkerDevicor Medical Products, Inc. Jul 13, 2023
K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc. Jul 13, 2023
K231064 — ReddyPort ElbowSmd Manufacturing, LLC Jul 13, 2023
K231438 — Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc. Jul 13, 2023
K223728 — Micro RxImds Operations B.V. Jul 13, 2023
K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control KitZeus Scientific Jul 13, 2023
K230877 — Admira Fusion 5Voco GmbH Jul 13, 2023
K231449 — Portable X-ray System Model Ray98(P)Ningbo Runyes Medical Instrument Co., Ltd. Jul 13, 2023
K230611 — X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd. Jul 13, 2023
K231833 — Biograph Vision.X and Biograph Vision.X EdgeSiemens Medical Solutions USA, Inc. Jul 13, 2023
K231754 — Praxiject™ 0.9% NaClMedxl, Inc. Jul 13, 2023
K231769 — activL® Next Generation InstrumentationAesculap Implants Systems, LLC Jul 13, 2023
K223261 — Open RibCanon Medical Informatics, Inc. Jul 13, 2023
K223426 — ECHELON Synergy MRI systemFujifilm Healthcare Corporation Jul 13, 2023
K231351 — Chondral QuantSiemens Medical Soultions USA, Inc. Jul 13, 2023
K223631 — Comprehensive Segmental Revision System(SRS)Biomet Orthopedics Jul 12, 2023
K231709 — AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4Radmedix, LLC Jul 12, 2023
K223808 — Zavation Navigation Instrument SystemZavation Medical Products, LLC Jul 12, 2023
K231241 — NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC Jul 12, 2023
K231035 — FusedCO AlgorithmEdwards Lifesciences, LLC Jul 12, 2023
K231714 — Graftys QuicksetGraftys Jul 12, 2023
K230532 — RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLC Jul 12, 2023
K230823 — AusculThing ACCAusculthing OY Jul 12, 2023
K231386 — Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc. Jul 11, 2023
K230307 — Dentis i-Clean SystemDentis Co., Ltd. Jul 11, 2023
K231528 — Bonalive Orthopedics granulesBonalive Biomaterials, Ltd. Jul 11, 2023
K221137 — Play and Joy Water-Based LubricantInnovemed Bio-Tech Co., Ltd. Jul 11, 2023
K231711 — microINR SystemIline Microsystems, S.L. Jul 11, 2023
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