510(k) Clearances in 2023 — Page 47

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 47 of 67)
510(k) clearancesDetails
K223805 — AgnesAgnes Medical Co., Ltd. May 4, 2023
K230960 — DLP™ Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. May 4, 2023
K230266 — Orchid Safety Release ValveLinear Health Sciences, LLC May 4, 2023
K222847 — Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos Medicos May 4, 2023
K220322 — Pollogen STOP U Model UXV DevicePollogen, Ltd. May 4, 2023
K230938 — ARIX Humerus SystemJeil Medical Corporation May 3, 2023
K222421 — SphincterotomeHangzhou AGS MedTech Co., Ltd. May 3, 2023
K230655 — PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd. May 3, 2023
K230203 — Dentis I-FIX AbutmentDentis Co., Ltd. May 3, 2023
K230123 — Apollo Knotless Suture AnchorMaruho Medical May 3, 2023
K230948 — BFlex™ 2 Slim 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc May 3, 2023
K212743 — MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) SystemMedschenker, Inc. May 3, 2023
K223843 — FloPatch FP120Flosonics Medical May 3, 2023
K223758 — EpioneQuantum Surgical Sas May 3, 2023
K230934 — ViewFlex™ Eco Reprocessed ICE CatheterABBOTT MEDICAL May 3, 2023
K230614 — Cortium™Ulrich Medical USA May 2, 2023
K230977 — SIS SystemSurgical Information Sciences, Inc. May 2, 2023
K223907 — NuEra Tight RF Model APMD145.M70-USBios S.R.L. May 2, 2023
K230606 — AcQMap® High Resolution Imaging and Mapping SystemAcutus Medical, Inc. May 2, 2023
K223511 — Excella Navigation InstrumentsInnovasis, Inc. May 2, 2023
K221779 — ASEPT Peritoneal Drainage SystemPfm Medical, Inc. May 2, 2023
K230880 — CoreLink Navigation InstrumentsCorelink, LLC May 2, 2023
K223495 — Zeolite Hemostatic CottonHangzhou Zeo-Innov Life Technology Co., Ltd. May 2, 2023
K212579 — FortiShield (Biosynthetic Wound Matrix)Organogenesis, Inc. May 2, 2023
K223529 — PressON Spinal Fixation SystemNexus Spine, LLC May 2, 2023
K230119 — 3D Anatomic ModelRicoh USA, Inc. May 2, 2023
K230912 — Artix BGInari Medical May 2, 2023
K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd. May 2, 2023
K230957 — TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences May 2, 2023
K221870 — CarnaLife HoloMedapp S.A. May 1, 2023
K223595 — vPATCHVirility Medical , Ltd. May 1, 2023
K222416 — RIA SafeguardRia Tech Co., Ltd. May 1, 2023
K223182 — Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 AlloyWorldwork S.R.L May 1, 2023
K230643 — CP620G LCD monitor, CP620 LCD monitorNanjing Jusha Display Technology Co., Ltd. May 1, 2023
K230972 — Ingenia Elition and MR 7700 MR SystemsPhilips Medical Systems Nederland B.V. Apr 28, 2023
K230042 — Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. Apr 28, 2023
K222934 — Nanox.ARCNano-X Imaging , Ltd. Apr 28, 2023
K223677 — Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB Apr 28, 2023
K230597 — Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V. Apr 28, 2023
K222636 — ET Abutment SystemHiossen, Inc. Apr 28, 2023
K230908 — Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc. Apr 28, 2023
K230058 — Bladeless Trocar – Artemis Lap CannulaT.A.G. Medical Products Corporation, Ltd. Apr 28, 2023
K220677 — Kurin Blood Culture Collection Set with Kurin Lock TechnologyKurin, Inc. Apr 28, 2023
K223634 — Customized AbutmentArum Dentistry Co., Ltd. Apr 28, 2023
K222004 — INTEGRATE -C Interbody Fusion SystemHappe Spine Apr 28, 2023
K213825 — Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5AJiangsu Yuyue Medical Equipment & Supply Co., Ltd. Apr 28, 2023
K230480 — Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Teleflex Medical Apr 28, 2023
K230600 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)Spectrum Dynamics Medical, Ltd. Apr 28, 2023
K221390 — BNLE Access GuidewireBiomerics Nle Apr 28, 2023
K223862 — Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUpWontech Co., Ltd. Apr 28, 2023
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