510(k) Clearances — Page 67
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K251240 — Branchor X Balloon Guide Catheter | Asahi Intecc Co., Ltd. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243062 — BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) | Becton Dickinson Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250968 — PathPresenter Clinical Viewer | Pathpresenter Corporation Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250566 — EsCem RMGI | Spident Co., Ltd. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250151 — Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.Ai Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251248 — ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02) | Jinhua Qidian Vehicle Co., Ltd. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250880 — LED LIGHT MASK (A093) | Foshan Guangyu Weilai Medical Equipment Co., Ltd. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250037 — Incompass Total Ankle System | Wright Medical Technology, Inc. (Stryker) Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251560 — FUBUKI XF-R Neurovascular Long Sheath | Asahi Intecc Co., Ltd. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243978 — LED Facial Mask | Shenzhen Sunsred Technology Co.,Ltd Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251258 — MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | Medtronic, Inc. Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250515 — EpiMonitor | Empatica S.r.l. Thu Jun 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242944 — Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.P.A. Thu Jun 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251235 — Electrosurgical Pads | Baisheng Medical Co., Ltd. Thu Jun 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45) | Shanghai Saints Sages Surgical Co., Ltd. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243366 — DRX9000C-SL Cervical Spinal Decompression System | Excite Medical of Tampa Bay, LLC Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251530 — CONMED Argo Knotless® Anchor | Conmed Corporation Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242922 — Extracorporeal Shock Wave Lithotripter (U200) | Shenzhen Wikkon Precision Technologies Co., Ltd. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250872 — Bioline Dental Implant System | Bioline Dental Implant Systems, Ltd. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250845 — Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243672 — CardIQ Suite | GE Medical Systems SCS Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242917 — Enteral Drainage System, Enteral Medicine straw | HMC Premedical S.p.A. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250908 — Virata Spinal Fixation System | SeaSpine Orthopedics Corporation Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243253 — 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | Esaote, S.p.A. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251296 — The Acumed Wrist Fixation System | Acumed, LLC Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243014 — EyeQ nanoECP | Eyeq, Inc. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250492 — FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243102 — Mobility Scooter (JT10) | Jiangxi Jiangte Electric Vehicle Co., Ltd. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243172 — Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles | O&M Halyard, Inc. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251253 — PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port | Bard Access Systems, Inc. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251634 — LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International, Inc. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242933 — SPINEART Navigation Instrument System | Spineart SA Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250886 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250082 — Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242224 — Happy Health Home Sleep Test | Happy Health, Inc. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243039 — Ureteral Stents (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243583 — F&P Nova Nasal Mask | Fisher & Paykel Healthcare Limited Wed Jun 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251017 — CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243133 — Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid | Kl-Kepong Rubber Products Sdn. Bhd. Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250997 — Integrity Implant | Anika Therapeutics, Inc. Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250219 — Dorado PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240066 — COAPTIUM Connect with TISSIUM LIGHT | Tissium SA Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243880 — Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | Wuxi Hisky Medical Technologies Co., Ltd. Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243618 — EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | Bridge TO Life Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243666 — uOmniscan | Shanghai United Imaging Healthcare Co., Ltd. Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240038 — Oxiplex® | Fziomed, Inc. Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250665 — SKR 3000 | Konica Minolta, Inc. Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243561 — Nano-Check Influenza+COVID-19 Dual Test | Nano-Ditech Corporation Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243003 — VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250440 — RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Brainlab AG Tue Jun 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |