510(k) Clearances in 2023 — Page 20

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 20 of 67)
510(k) clearancesDetails
K230825 — Smileyscope System (Therapy Mode)Smileyscope Holding, Inc. Sep 25, 2023
K231928 — EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd. Sep 25, 2023
K231888 — BD Texium™ Needle-Free SyringeCare Fusion Sep 25, 2023
K232097 — IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc. Sep 25, 2023
K230778 — EndoCorePraxis Medical, LLC Sep 25, 2023
K231739 — Cervical Spine Truss System (CSTS)4Web Medical, Inc. Sep 25, 2023
K223933 — Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc. Sep 25, 2023
K231891 — Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast Sep 25, 2023
K231977 — PEACH 2, PEACH 2 Duo, PEACH 2 goForeo, Inc. Sep 25, 2023
K230857 — TiLink-P SI Joint Fusion SystemSurGenTec, LLC Sep 25, 2023
K230184 — Holter ECG and ABP SystemEdan Instruments, Inc. Sep 25, 2023
K220265 — ADVIA Centaur® NT-proBNPII (PBNPII)Siemens Healthcare Diagnostics, Inc. Sep 24, 2023
K223919 — B.Light Clear Evo and B.Light Restore EvoBemer Int AG Sep 23, 2023
K222778 — Osstem Implant SystemOsstem Implant Co., Ltd. Sep 23, 2023
K231767 — Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty , Ltd. Sep 22, 2023
K232571 — CATHTONG™ II PICC CatheterL&Z Us, Inc. Sep 22, 2023
K232594 — CATHTONG™ II PICC CatheterL&Z Us, Inc. Sep 22, 2023
K232193 — Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)Yurob Rehabilitation Medical Co., Ltd. Sep 22, 2023
K232978 — DX. Bond V Dental Bonding AdhesiveSino-Dentex Co., Ltd. Sep 22, 2023
K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsFoshan Coxo Medical Instrument Co., Ltd. Sep 22, 2023
K223659 — JazzAi Medical AG Sep 22, 2023
K232558 — UroLift 2 ATC Advanced Tissue Control SystemNeotract, Inc. Sep 22, 2023
K231092 — T-SHAPE 2B&M S.R.L. Marketing Nel Benessere Sep 22, 2023
K230350 — VISULAS yagCarl Zeiss Meditec, Inc. Sep 22, 2023
K231446 — Single-Use Latex Sterile Surgical Gloves (SG100)Fitone Latex Products Co., Ltd. Guangdong Sep 22, 2023
K221817 — ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc., Sep 22, 2023
K231479 — TriALTIS Spine SystemMedos International SARL Sep 22, 2023
K230067 — Para-Fix External Fixation SystemNew Paradigm Biomedical Sep 22, 2023
K231239 — Nexiva™ Closed IV Catheter System with NearPort™ IV AccessBecton Dickinson Infusion Therapy Systems, Inc. Sep 22, 2023
K223921 — Access CEABeckman Coulter, Inc. Sep 22, 2023
K231149 — qXR-CTRQure.Ai Technologies Sep 22, 2023
K232224 — iLet® Dosing Decision SoftwareBeta Bionics, Inc. Sep 22, 2023
K230980 — MicroMatrix® FlexAcell, Inc. Sep 22, 2023
K231730 — FemaSeed Intratubal InseminationFemasys, Inc. Sep 22, 2023
K232183 — IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10Shenzhen Koli Technology Co.,Ltd Sep 22, 2023
K231384 — Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty , Ltd. Sep 22, 2023
K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLC Sep 21, 2023
K231678 — Overjet Periapical Radiolucency AssistOverjet, Inc. Sep 21, 2023
K231401 — Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited Sep 21, 2023
K232569 — CAREMIBRAINGeneral Equipment For Medical Imaging, S.A. Sep 21, 2023
K230102 — Smart double sides wearable breast pump, Electric bilateral breast pumpHuizhou Lvb Maternal And Infant Supplies Co., Ltd. Sep 21, 2023
K230226 — Integrity-SI® Fusion SystemOsteoCentric Technologies Sep 21, 2023
K230193 — Servator P Plus SALF SolutionS.A.L.F. Spa Sep 21, 2023
K223354 — EGIS Biliary Single Bare StentS&G Biotech, Inc. Sep 21, 2023
K230467 — BTL-899FBTL Industries, Inc. Sep 21, 2023
K223214 — Powder-Free Nitrile Examination GlovesGlobal Protection Corp. Sep 21, 2023
K232159 — QEVO SystemCarl Zeiss Meditec, AG Sep 21, 2023
K230767 — Pelvic Floor Muscle StimulatorNanjing Vishee Medical Technology Co., Ltd. Sep 21, 2023
K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker Sep 20, 2023
K230692 — TULSA-PRO SystemProfound Medical, Inc. Sep 20, 2023
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