510(k) Clearances in 2023 — Page 42

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 42 of 67)
510(k) clearancesDetails
K230888 — Titanium TurbineNakanishi, Inc. Jun 2, 2023
K231293 — Drakon™ and Sequre® MicrocathetersAccurate Medical Therapeutics Jun 1, 2023
K223555 — Brainomix 360 e-CTPBrainomix Limited Jun 1, 2023
K223498 — Radius VSM and AccessoriesMasimo Corporation Jun 1, 2023
K230185 — ANT-X SystemNdr Medical Technology Pte. , Ltd. Jun 1, 2023
K223447 — OmniTom EliteNeurologica Corporation, A Subsidiary Of Samsung Jun 1, 2023
K230408 — K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)Sb-Kawasumi Laboratories, Inc. Jun 1, 2023
K230990 — Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation Jun 1, 2023
K222905 — Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)Ningbo Maxcon Medical Technology Co., Ltd. Jun 1, 2023
K223299 — Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 AdvanceAmbu A/S Jun 1, 2023
K231306 — cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc. Jun 1, 2023
K223676 — SomniCheckBrainmatterz, LLC Jun 1, 2023
K230617 — Surgical Face Mask (L 175*95mm)Henan Chaoya Medical Equipment Co., Ltd. Jun 1, 2023
K230827 — HardyDisk AST Rezafungin 5µg (RZF5)Hardy Diagnostics Jun 1, 2023
K223929 — Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)Innova Vascular, Inc. Jun 1, 2023
K231330 — FiberTak® Suture AnchorArthrex, Inc. Jun 1, 2023
K213992 — CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC May 31, 2023
K211056 — Oxus Sieve BedsOxus, Inc. May 31, 2023
K230542 — Disposable Nitrile Gloves (ABC-DG01)Huizhou Anboson Technology Co., Ltd. May 31, 2023
K221067 — Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterSurgical Instrument Service And Savings, Inc. May 31, 2023
K231326 — Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)Osteonic Co., Ltd. May 31, 2023
K213010 — FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd. May 31, 2023
K222885 — Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)Pegavision Corporation May 31, 2023
K222644 — Nihon Kohden NKV-440 Ventilator SystemNihon Kohden Orangemed, Inc. May 31, 2023
K230671 — Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd. May 31, 2023
K231259 — iRoot SP PlusInnovative Bioceramix, Inc. May 31, 2023
K222556 — BTL-785XBTL Industries, Inc. May 31, 2023
K223762 — Smith & Nephew ACCORD™ Cable SystemSmith & Nephew May 30, 2023
K230030 — Excipio SV Aspiration Catheter and TubingContego Medical, Inc. May 30, 2023
K220706 — MyPAO GuidesMedacta International S.A. May 30, 2023
K230593 — VictanJiangsu Haize Medical Scientific Development Co., Ltd. May 30, 2023
K223523 — Sonic DLGe Medical Systems,Llc (Ge Healthcare) May 30, 2023
K222359 — Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (O8T) May 30, 2023
K230571 — RFP-100A Connector Cable (Single Use)Baylis Medical Technologies, Inc. May 30, 2023
K230278 — Babyroo TN300Draeger Medical Systems, Inc. May 30, 2023
K223809 — PrecisionTAVI (v1.1)Dasi Simulations May 30, 2023
K230909 — EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd. May 30, 2023
K230958 — First Glove Blue Nitrile Examination Gloves Powder FreeFirst Glove Sdn. Bhd. May 30, 2023
K223841 — KBA3DS.M.A.I.O May 30, 2023
K221897 — Hydrozid PreciseBibawo Medical A/S May 30, 2023
K230601 — Blue Nitrile Examination Gloves Powder FreeLatrile Gloves Private Limited May 28, 2023
K230557 — Eclipse Treatment Planning System (v18.0)Varian Medical Systems, Inc. May 26, 2023
K230065 — VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation SystemFiagon GmbH May 26, 2023
K230263 — Finesse™ Injectable PTA Balloon Dilatation CatheterSumma Therapeutics, LLC May 26, 2023
K231233 — Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc. May 26, 2023
K230111 — CORE 500 Digital StethoscopeEko Devices, Inc. May 26, 2023
K223626 — Niti-S Biliary Speed D StentTaewoong Medical Co., Ltd. May 26, 2023
K203599 — Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemImmuno Concepts, N.A. , Ltd. May 26, 2023
K230851 — Kodiak Lumbar Spacer SystemMet One Technologies, LLC May 26, 2023
K223096 — Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC May 26, 2023
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