| K242665 — DePuy ATTUNE Total Knee System | Depuy Orthopedics, Inc. Nov 1, 2024 |
| K242269 — SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) | Quanta Dialysis Technologies, Ltd. Nov 1, 2024 |
| K241646 — ORTIV (ORTIV-BL, ORTIV-WH) | Mvitro Co., Ltd. Nov 1, 2024 |
| K242452 — Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. Nov 1, 2024 |
| K243091 — Over-tube (TR-1108A) | Fujifilm Corporation Nov 1, 2024 |
| K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. Nov 1, 2024 |
| K243381 — Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc. Nov 1, 2024 |
| K240366 — EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation Nov 1, 2024 |
| K241999 — Prophecy Surgical Planning System | Wright Medical Technology, Inc. (Stryker) Nov 1, 2024 |
| K240388 — Osteotomy Truss System (OTS) | 4Web Medical, Inc. Nov 1, 2024 |
| K240383 — Highness Implant System | Highness Co., Ltd. Oct 31, 2024 |
| K240653 — SmartCardia 7L Platform (MCT) | Smartcardia SA Oct 31, 2024 |
| K241223 — eRAD PACS | Erad, Inc. Oct 31, 2024 |
| K240455 — BD Vacutainer® Citrate Blood Collection Tubes | Becton, Dickinson And Company Oct 31, 2024 |
| K242623 — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | Shenzhen Medke Technology Co., Ltd. Oct 31, 2024 |
| K243181 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | Bionova Medical, Inc. Oct 31, 2024 |
| K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports | Bard Access Systems, Inc. Oct 31, 2024 |
| K240375 — V80 Anesthetic Vaporizer (V80) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Oct 31, 2024 |
| K242399 — Bonebridge Osteosynthesis Plating System | Bonebridge AG Oct 31, 2024 |
| K242627 — Safety Lancet | Ningbo Medsun Medical Co., Ltd. Oct 30, 2024 |
| K242271 — Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. Oct 30, 2024 |
| K240847 — MedicCO2LON (MedicCO2LON) | Ide Vision, Ltd. Oct 30, 2024 |
| K240334 — LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) | Lagis Enterprise Co., Ltd. Oct 30, 2024 |
| K240333 — Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. Oct 30, 2024 |
| K241533 — NeurAxis IB-Stim (01-1020) | Neuraxis Oct 30, 2024 |
| DEN230082 — Stone Clear (SC-LP9-01) | Sonomotion, Inc. Oct 30, 2024 |
| K240560 — ZENEX Implant System_Long | Izenimplant Co., Ltd. Oct 30, 2024 |
| K240670 — DRI Ecstasy Plus Assay | Microgenics Corporation Oct 30, 2024 |
| K243186 — Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family | Siemens Medical Solutions USA, Inc. Oct 30, 2024 |
| K241108 — RemedyLogic AI MRI Lumbar Spine Reader | Remedy Logic, Inc. Oct 30, 2024 |
| K242711 — JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. Oct 30, 2024 |
| K240177 — Zio AT® device (A100A1001) | iRhythm Technologies, Inc. Oct 30, 2024 |
| K241902 — Edison System | HistoSonics, Inc. Oct 30, 2024 |
| K242256 — QIAstat-Dx Meningitis/Encephalitis (ME) Panel | QIAGEN GmbH Oct 29, 2024 |
| K243080 — Riptide Aspiration System | Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Oct 29, 2024 |
| K241077 — DeGen Medical Patient Specific Implant (PSI) System | Degen Medical Oct 29, 2024 |
| K240175 — Tigon Medical Fractures, Instability, and Reconstruction (FIRE) | Tigon Medical Oct 29, 2024 |
| K241612 — Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) | Hunan Vathin Medical Instrument Co., Ltd. Oct 29, 2024 |
| K243247 — Persona the Personalized Knee System | Zimmer, Inc. Oct 29, 2024 |
| K243157 — AtriCure cryoICE BOX (ACM) | AtriCure, Inc. Oct 29, 2024 |
| K243095 — Mammotome AutoCore Single Insertion Core Biopsy System | Devicor Medical Products, Inc. Oct 29, 2024 |
| K243126 — TRACHEOBRONXANE DUMON® | Novatech SA Oct 29, 2024 |
| K243203 — OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor | Riverpoint Medical Oct 29, 2024 |
| K241366 — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) | Dehas Medical Systems GmbH Oct 29, 2024 |
| K241965 — Catheter Surface Flap Applicator Set (GM11011830) | Varian Medical Systems Oct 29, 2024 |
| K241189 — Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02) | Jiaxing Xiaoxiang Medical Equipment Technology Co., Ltd. Oct 29, 2024 |
| K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC Oct 28, 2024 |
| K240303 — MetaLite DX Digital Pathology Software | Jellox Biotech, Inc. Oct 28, 2024 |
| K243137 — Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. Oct 28, 2024 |
| K241718 — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. Oct 28, 2024 |