510(k) Clearances in 2023 — Page 44

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 44 of 67)
510(k) clearancesDetails
K230460 — Laser Thermal Therapy KitElesta S.P.A May 22, 2023
K230464 — MixJect® Transfer DeviceWest Pharma. Services IL, Ltd. May 22, 2023
K230373 — HELIOS 785 PicoLaseroptek Co., Ltd. May 22, 2023
K230631 — Kodiak™ Dual Port Coaxial Introducer KitArgon Medical Devices May 22, 2023
K220722 — PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd. May 22, 2023
K230708 — Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)Gbs Commonwealth Co., Ltd. May 22, 2023
K223839 — TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc. May 22, 2023
K221323 — Exactech® Alteon® Short Tapered WedgeExactech, Inc. May 19, 2023
K230769 — PrevisEA DeviceEntac Medical, Inc. May 19, 2023
K231140 — aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc. May 19, 2023
K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesAbbott Laboratories May 19, 2023
K212758 — AutoplaqueCedars-Sinai Medical Center: Aim May 19, 2023
K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker May 19, 2023
K220916 — iLet® Dosing Decision SoftwareBeta Bionics, Inc. May 19, 2023
K222703 — ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX)Moving Life, Ltd. May 19, 2023
K230375 — BIOMONITOR IVBiotronik, Inc. May 19, 2023
K222979 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5WMicrolife Intellectual Property GmbH May 19, 2023
K222833 — Ventana™ C Spinal SystemSpinal Elements, Inc. May 19, 2023
K223486 — SafeBreak® VascularLineus Medical May 19, 2023
K222545 — Disposable Medical MaskGuangzhou Fuzelong Hygiene Material Co., Ltd. May 19, 2023
K231137 — Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd. May 19, 2023
K223846 — iLet® ACE PumpBeta Bionics, Inc. May 19, 2023
K230537 — Klassic Knee Revision SystemTotal Joint Othopedics, Inc. May 19, 2023
K220402 — VirtuOstO.N. Diagnostics May 19, 2023
K220842 — Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsQura S.R.L May 19, 2023
K231143 — GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd. May 19, 2023
K223269 — Spencer Probe Depth ElectrodesAd-Tech Medical Instrument Corporation May 18, 2023
K223645 — I.V. Administration Set, I.V. Extension SetBq Plus Medical Co., Ltd. May 18, 2023
K222578 — 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company May 18, 2023
DEN220027 — B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test SystemBrahms GmbH, Part Of Thermo Fisher Scientific May 18, 2023
K230479 — ComASP Cefiderocol 0.008-128Liofilchem S.R.L. May 18, 2023
K220829 — Endo MotorFoshan Coxo Medical Instrument Co., Ltd. May 18, 2023
K230758 — uMR 570Shanghai United Imaging Healthcare Co., Ltd. May 18, 2023
K230723 — C510G/JUSHA-C510G/C510/JUSHA- C510 LCD MonitorNanjing Jusha Display Technology Co., Ltd. May 18, 2023
K222356 — Claritag AdvancedDgi Technologies May 18, 2023
K223725 — Restrata® MiniMatrixAcera Surgical, Inc. May 18, 2023
K223276 — Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument Corporation May 18, 2023
K230432 — Single Use Bipolar ForcepsHg Innovations, Ltd. May 18, 2023
K231113 — Arthrex FiberTak Suture AnchorArthrex, Inc. May 18, 2023
K230200 — Single-Use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd. May 18, 2023
K230453 — OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging CatheterBoston Scientific Corporation May 18, 2023
K222728 — Radiation Planning Assistant (RPA)University Of Texas, MD Anderson Cancer Center May 17, 2023
K230448 — DeepX DermoSight DermatoscopeDeepx Health, LLC May 17, 2023
K223696 — F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd. May 17, 2023
K231128 — JuggerKnot Soft AnchorRiverpoint Medical, LLC May 17, 2023
K230286 — Assert-IQ™ Insertable Cardiac MonitorABBOTT MEDICAL May 17, 2023
K223437 — Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)Hartalega NGC Sdn. Bhd. May 17, 2023
K231102 — Symbia Pro.specta VA20A FamilySiemens Medical Solutions USA, Inc. May 17, 2023
K220964 — VERSAJET Hydrosurgery System (III)Smith & Nephew Medical Limited May 16, 2023
K222207 — Babylog VN800, Babylog VN600Draegerwerk AG & CO Kgaa May 16, 2023
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