510(k) Clearances in 2023 — Page 23

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 23 of 67)
510(k) clearancesDetails
K231283 — SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.) Sep 11, 2023
K223755 — i-STAT G cartridge with the i-STAT 1 SystemAbbott Point Of Care, Inc. Sep 11, 2023
K230362 — Planar LED mateShenzhen Leaflife Technology Co., Ltd. Sep 11, 2023
K232192 — Venus Versa PRO SystemVenus Concept, Inc. Sep 11, 2023
K230881 — Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel , Ltd. Sep 11, 2023
K231746 — VERIFY Spore Test Strip for S40 Sterilant ConcentrateSTERIS Corporation Sep 11, 2023
K231504 — TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemVilex, LLC Sep 11, 2023
K230517 — Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)Jarmon Medical, LLC (Dba Legends Orthopedics) Sep 11, 2023
K232154 — MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC Sep 11, 2023
K232002 — Vantage® Total Ankle SystemExactech, Inc. Sep 11, 2023
K223864 — Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software CranialBrainlab AG Sep 9, 2023
K231723 — Sterile Safety Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd. Sep 8, 2023
K230372 — VitreJect SyringeOcuject, LLC Sep 8, 2023
K232686 — CorVista® SystemCorvista Health, Inc. Sep 8, 2023
K231727 — Sterile Auto-Disable Syringes with/without Needle for Single UseWepon Medical Technology Co., Ltd. Sep 8, 2023
K222921 — Minuteful-kidney testHealthy.Io, Ltd. Sep 8, 2023
K231643 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)Syntex Healthcare Products Co., Ltd. Sep 8, 2023
K232386 — ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6ABBOTT MEDICAL Sep 8, 2023
K232413 — Fusion Robotic Navigation SystemAlphatec Spine, Inc. Sep 8, 2023
K223848 — Intrisound™ Tuned Lumen® 155 Hearing AidsTuned , Ltd. Sep 8, 2023
K223621 — DeepXrayAlpha Intelligence Manifolds, Inc. Sep 8, 2023
K230661 — Zeta Cranial Navigation SystemZeta Surgical Sep 8, 2023
K232426 — Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertsConformis, Inc. Sep 8, 2023
K230535 — KARL STORZ Urological Laser AccessoriesKarl Storz SE & CO. KG Sep 8, 2023
K231729 — Sterile syringes for single use with/without needleWepon Medical Technology Co., Ltd. Sep 8, 2023
K232400 — VariSeed (v10)Varian Medical Systems Sep 8, 2023
K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MASiemens Healthcare Diagnostics Products, Ltd. Sep 8, 2023
K231284 — OnPoint Augmented Reality Spine SystemOnpoint Surgical, Inc. Sep 8, 2023
K231720 — Sterile Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd. Sep 8, 2023
K230890 — ISE ElectrodesRandox Laboratories, Ltd. Sep 8, 2023
K231335 — Cleerly ISCHEMIACleerly, Inc. Sep 8, 2023
K232414 — Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc. Sep 8, 2023
K231141 — STarFix Designer Software C0265FHC, Inc. Sep 8, 2023
K231146 — AliTightAlic Iotech, LLC Sep 8, 2023
K232457 — Q-FIX ULTRA All-Suture AnchorSmith & Nephew Sep 8, 2023
K231471 — Air/Water Bottle Tubing, CO2 Source TubingZhejiang Chuangxiang Medical Technology Co., Ltd. Sep 8, 2023
K231240 — MaxTack™ Motorized Fixation DeviceCovidien Sep 8, 2023
K232166 — PreXion3D ExpeditionPrexion Corporation Sep 8, 2023
K230310 — STAT Medical Device Lancing SystemStat Medical Devices Sep 8, 2023
K223827 — FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01Fujifilm Corporation Sep 8, 2023
K222823 — AeroDVx Arm SystemSun Scientific, Inc. Sep 7, 2023
K232389 — Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation Sep 7, 2023
K231800 — IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9Shenzhen Qianyu Technology Co., Ltd. Sep 7, 2023
K232443 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc. Sep 7, 2023
K231687 — Gradual Dental Zirconia BlankLiaoning Upcera Co., Ltd. Sep 7, 2023
K231207 — CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)Biosense Webster, Inc. Sep 7, 2023
K231542 — Digital Blood Pressure Monitor WBP SeriesWeony (Shenzhen) Technology Co., Ltd. Sep 7, 2023
K221743 — Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical ElectrodesJiangsu Bonss Medical Technology Co., Ltd. Sep 7, 2023
K230649 — Arm Blood Pressure MonitorAlicn Medical Shenzhen, Inc. Sep 7, 2023
K231996 — Steriking® LT-Blueline Pouches with Tyvek®Wipak OY Sep 7, 2023
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