510(k) Clearances — Page 196

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 196 of 3,525)
ClearancesDetails
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
K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A. Sep 20, 2023
K232582 — Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S Sep 20, 2023
K232583 — Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. Sep 20, 2023
K223179 — Cholestech LDX ™ SystemAlere San Diego, Inc. Sep 20, 2023
K232592 — CITRELOCK® DUOAcuitive Technologies, Inc. Sep 20, 2023
K232556 — DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup SystemDepuy Ireland UC Sep 20, 2023
K223913 — Socrates Aspiration SystemScientia Vascular, Inc. Sep 20, 2023
K231894 — LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd. Sep 20, 2023
K231385 — Rology Teleradiology Platform (v.1.22.1103)Rology, Inc. Sep 20, 2023
K230011 — Mpact ExtensionMedacta International S.A. Sep 20, 2023
K231342 — Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc. Sep 20, 2023
K230239 — AirSeal iFS System; AirSeal dV SolutionConmed Corporation Sep 20, 2023
K230043 — Insulin Pen NeedleAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Sep 20, 2023
K223421 — MedCAD AccuPlan Orthopedics SystemMedcad Sep 20, 2023
K231281 — Aquilion Serve (TSX-307A/1) V1.3Canon Medical Systems Corporation Sep 19, 2023
K230966 — angiOCCLUDE Ligating ClipsA2 Medical Systems, LLC Sep 19, 2023
K222948 — Q Distal Access CatheterMivi Neuroscience, Inc. Sep 19, 2023
K231802 — Millipede 088 Access CatheterPerfuze, Ltd. Sep 19, 2023
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