510(k) Clearances — Page 110
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240375 — V80 Anesthetic Vaporizer (V80) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Thu Oct 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242399 — Bonebridge Osteosynthesis Plating System | Bonebridge AG Thu Oct 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241533 — NeurAxis IB-Stim (01-1020) | Neuraxis Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241108 — RemedyLogic AI MRI Lumbar Spine Reader | Remedy Logic, Inc. Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242627 — Safety Lancet | Ningbo Medsun Medical Co., Ltd. Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240333 — Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230082 — Stone Clear (SC-LP9-01) | Sonomotion, Inc. Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240847 — MedicCO2LON (MedicCO2LON) | Ide Vision, Ltd. Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240560 — ZENEX Implant System_Long | Izenimplant Co., Ltd. Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242271 — Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240670 — DRI Ecstasy Plus Assay | Microgenics Corporation Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242711 — JOURNEY II Unicompartmental Knee System (JOURNEY II UK) | Smith & Nephew, Inc. Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240177 — Zio AT® device (A100A1001) | iRhythm Technologies, Inc. Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241902 — Edison System | HistoSonics, Inc. Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242256 — QIAstat-Dx Meningitis/Encephalitis (ME) Panel | QIAGEN GmbH Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240175 — Tigon Medical Fractures, Instability, and Reconstruction (FIRE) | Tigon Medical Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243080 — Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241077 — DeGen Medical Patient Specific Implant (PSI) System | Degen Medical Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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. Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243247 — Persona the Personalized Knee System | Zimmer, Inc. Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243157 — AtriCure cryoICE BOX (ACM) | AtriCure, Inc. Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243095 — Mammotome AutoCore Single Insertion Core Biopsy System | Devicor Medical Products, Inc. Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243126 — TRACHEOBRONXANE DUMON® | Novatech SA Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243203 — OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor | Riverpoint Medical Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241366 — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) | Dehas Medical Systems GmbH Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241965 — Catheter Surface Flap Applicator Set (GM11011830) | Varian Medical Systems Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241189 — Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02) | Jiaxing Xiaoxiang Medical Equipment Technology Co., Ltd. Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241992 — Catalyft LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. Mon Oct 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243137 — Curiteva Porous PEEK Laminoplasty System | Curiteva, Inc. Mon Oct 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241718 — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. Mon Oct 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240303 — MetaLite DX Digital Pathology Software | Jellox Biotech, Inc. Mon Oct 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 Mon Oct 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242622 — Sterile Lancets for Single Use | Ningbo Caremed Medical Products Co., Ltd. Mon Oct 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242350 — Spinal Alignment Solutions Pelvic Incidence (PI) Rod System | Spinal Alignment Solutions, Inc. Mon Oct 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242969 — Pantera Pro; Pantera LEO | Biotronik, Inc. Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230084 — Dexter L6 System | Distalmotion SA Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243031 — LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242397 — LYNX Photocoagulator | Norlase Aps Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240918 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism | Bruno Vision Care, LLC Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243189 — TumorSight Viz | SimBioSys, Inc. Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240223 — FMT Disposable and Autoclavable Temperature Probes | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243070 — Xpert® SA Nasal Complete | Cepheid® Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242215 — Neurophet AQUA (V3.1) | Neurophet., Inc. Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243030 — Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) | Ulike Co., Ltd. Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242625 — Freeze Point & Private Label Versions | Cryoconcepts LP Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240092 — Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) | Shenzhen Yimi Life Technology Co., Ltd. Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243173 — Salto Talaris Ankle PSI System | 3D Systems, Inc. Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242353 — QIAstat-Dx Respiratory Panel Mini | QIAGEN GmbH Fri Oct 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |