| K240924 — Anterion | Heidelberg Engineering GmbH Fri Dec 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242532 — BTL-785BNF-E | BTL Industries, Inc. Fri Dec 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240998 — ABL90 FLEX PLUS System | Radiometer Medicals Aps Fri Dec 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240778 — Vivo 1, Vivo 2 | Breas Medical AB Fri Dec 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242487 — Laminar P1 (LDH-HW-001) | Laminar Digital Health, Inc. Fri Dec 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241998 — Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) | Shenzhen Ulike Smart Electronics Co., Ltd. Fri Dec 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242668 — Gastro Concepts Air Assist | Gastro Concepts, LLC Fri Dec 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240779 — Vivo 3 | Breas Medical AB Fri Dec 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243196 — Uro-G HD Cystoscope (1520) | Uroviu Corporation Fri Dec 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233486 — 731 Series Ventilator | ZOLL Medical Corporation Fri Dec 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242934 — Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) | Longly Biotechnology (Wuhan) Co., Ltd. Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) | Terragene S.A. Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241271 — Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242020 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241389 — Infrascanner Model 2500 (Model 2500) | Infrascan, Inc. Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240735 — visio.lign color, visio.lign shield | Bredent GmbH & Co. KG Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243538 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233152 — GENIOVA aligners | Geniova Technologies Sociedad Limitada Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) | Ge Medical Systems Information Technologies, Inc. Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241253 — Medicon Epiplating System | Cmf Medicon Surgical, Inc. Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242832 — NExT Station; NExT Station Advanced | Eb Neuro S.P.A. Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243495 — Natus Ultrapro S100 (982A0594) | Natus Neurology Incorporated Thu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243491 — SternalPlate Expansion | Stryker Leibinger GmbH & Co KG Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241219 — FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) | ZuriMED Technologies AG Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241088 — EndoTool IV (3.1) | Monarch Medical Technologies Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243369 — Cervical Plating System | Life Spine, Inc. Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240758 — Radiofrequency Generator System, Cura RF Electrode | Zhejiang Curaway Medical Technology Co., Ltd. Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243498 — Alinity c Benzodiazepines Reagent Kit | Microgenics Corporation Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242417 — VECTR Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242747 — FAQ (302) | Foreo, Inc. Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243548 — BriefCase-Triage | Aidoc Medical , Ltd. Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242378 — Eclipse Treatment Planning System (18.1) | Varian Medical Systems Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241045 — Disposable Subdermal Needle Electrode, Corkscrew | Technomed Europe Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242033 — Access25 Delivery Microcatheter | Penumbra, Inc. Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242263 — TECHFIT DISRP® System | Techfit Digital Surgery, Inc. Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241873 — OsseoFit Stemless Shoulder System | Zimmer, Inc. Wed Dec 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242025 — Elos Accurate® Hybrid Base | Elos Medtech Pinol A/S Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241521 — Prelude Small O.D. Introducer Guide Wire | Merit Medical Systems, Inc. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242848 — Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242461 — IRISeg | Intuitive Surgical, Inc. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243132 — Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) | Shantou Institute of Ultrasonic Instruments Co., Ltd. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241391 — Straumann® PURE Ceramic Implants | Institut Straumann AG Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242630 — Aerin Console | Aerin Medical, Inc. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242511 — V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231216 — POTENZA | Jeisys Medical, Inc. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242327 — Empulse M90 | Concourse Assistive Technology Pty, Ltd. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241505 — DRX-Revolution Mobile X-ray System | Carestream Health, Inc. Tue Dec 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242729 — AutoContour (Model RADAC V4) | Radformation, Inc. Mon Dec 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | Edwards Lifesciences Mon Dec 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |