510(k) Clearances

174,759 clearances total

K223771 — Lumify Diagnostic Ultrasound SystemPhilips Ultrasound Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230530 — SOZO ProImpediMed Limited Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K203245 — Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03CNucleix , Ltd. Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223805 — AgnesAgnes Medical Co., Ltd. Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230960 — DLP™ Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230266 — Orchid Safety Release ValveLinear Health Sciences, LLC Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223756 — SimPro™ Now, GentleCath™ HydrophilicDentsply Sirona Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222847 — Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos Medicos Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222097 — OLYMPIC Deformity Band SystemAstura Medical Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K220322 — Pollogen STOP U Model UXV DevicePollogen, Ltd. Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222421 — SphincterotomeHangzhou AGS MedTech Co., Ltd. Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230203 — Dentis I-FIX AbutmentDentis Co., Ltd. Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230938 — ARIX Humerus SystemJeil Medical Corporation Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230655 — PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd. Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230123 — Apollo Knotless Suture AnchorMaruho Medical Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230948 — BFlex™ 2 Slim 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K212743 — MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) SystemMedschenker, Inc. Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223843 — FloPatch FP120Flosonics Medical Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223758 — EpioneQuantum Surgical Sas Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230934 — ViewFlex™ Eco Reprocessed ICE CatheterABBOTT MEDICAL Wed May 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230614 — Cortium™Ulrich Medical USA Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K221779 — ASEPT Peritoneal Drainage SystemPfm Medical, Inc. Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230977 — SIS SystemSurgical Information Sciences, Inc. Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223495 — Zeolite Hemostatic CottonHangzhou Zeo-Innov Life Technology Co., Ltd. Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230606 — AcQMap® High Resolution Imaging and Mapping SystemAcutus Medical, Inc. Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230880 — CoreLink Navigation InstrumentsCorelink, LLC Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223511 — Excella Navigation InstrumentsInnovasis, Inc. Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223907 — NuEra Tight RF Model APMD145.M70-USBios S.R.L. Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223529 — PressON Spinal Fixation SystemNexus Spine, LLC Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230119 — 3D Anatomic ModelRicoh USA, Inc. Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230912 — Artix BGInari Medical Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K212579 — FortiShield (Biosynthetic Wound Matrix)Organogenesis, Inc. Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd. Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230957 — TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences Tue May 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223595 — vPATCHVirility Medical , Ltd. Mon May 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K221870 — CarnaLife HoloMedapp S.A. Mon May 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222416 — RIA SafeguardRia Tech Co., Ltd. Mon May 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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 Mon May 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230643 — CP620G LCD monitor, CP620 LCD monitorNanjing Jusha Display Technology Co., Ltd. Mon May 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K220677 — Kurin Blood Culture Collection Set with Kurin Lock TechnologyKurin, Inc. Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230972 — Ingenia Elition and MR 7700 MR SystemsPhilips Medical Systems Nederland B.V. Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222636 — ET Abutment SystemHiossen, Inc. Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230597 — Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)Light Tree Ventures Europe B.V. Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230058 — Bladeless Trocar – Artemis Lap CannulaT.A.G. Medical Products Corporation, Ltd. Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223677 — Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K230908 — Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc. Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K223634 — Customized AbutmentArum Dentistry Co., Ltd. Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222934 — Nanox.ARCNano-X Imaging , Ltd. Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K222004 — INTEGRATE -C Interbody Fusion SystemHappe Spine Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
K213825 — Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5AJiangsu Yuyue Medical Equipment & Supply Co., Ltd. Fri Apr 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
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