510(k) Clearances — Page 113
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240364 — RELIEEV Uterine Manipulator Injector (CUMI 5.0) | Li Medical Corporation , Ltd. Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241244 — CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter | Cerenovus, Inc. Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230087 — AMStent® Tracheobronchial Covered Stent System | Peytant Solutions, Inc. Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240114 — UltraEzAir® (UEA1A) | Dualams, Inc., Dba Airkor Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242795 — Getinge Assured MI Steam Migrating Integrator | Steritec Products Mfg. (A Getinge Group Company) Tue Oct 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231997 — SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | Cure Point Therapeutics, Inc. Tue Oct 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240192 — Single-use Extraction Baskets | Scivita Medical Technology Co., Ltd. Tue Oct 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240385 — VINT | Mediimg Corporation Tue Oct 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242097 — DenMat Bulk Fill Composite | Den-Mat Holdings, LLC Tue Oct 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241894 — Artix MT; Artix Thin-Walled Thrombectomy Sheath | Inari Medical, Inc. Tue Oct 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242781 — cvi42 Software Application | Circle Cardiovascular Imaging, Inc. Tue Oct 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241673 — Denture Base Resin (PN-Denture (Red, White)) | Shenzhen Piocreat 3D Technology Co., Ltd. Tue Oct 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242536 — TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Tue Oct 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242812 — NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) | Nb Medical Company Limited Sat Oct 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240501 — Spark Clear Aligner System | Ormco Corporation Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232565 — UriSponge | Copan Italia Spa Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242779 — Hood (DH-083ST) | Fujifilm Corporation Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242095 — Access Toxo IgM II | Beckman Coulter, Inc. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241163 — SPECTRALIS with Flex Module | Heidelberg Engineering GmbH Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242387 — Mobility Scooter (N3473) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242778 — X Sensor (Model: IOS-A15IF, HDI-15DGF) | Qpix Solutions, Inc. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234110 — Belun Ring BLR-200 (BLR-200) | Belun Technology Company Limited Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242833 — Legend® Acetabular Shell | Ortho Development Corp. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240826 — Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | Sterilmed, Inc. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241153 — Progressive Orthodontics App | Progressive Aligners, Inc. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241857 — LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240143 — JDZygoma dental implants | Jdentalcare Srl Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233265 — Monotime and Optime R | Peters Surgical Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232779 — QUEX ED; QUEX S | Qx World, Ltd. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241971 — HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241569 — syngo Application Software | Siemens Medical Solutions USA, Inc. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240797 — PPH Saliva Collection Kit | Permantis Public Health Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242133 — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) | Centerline Biomedical, Inc. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242035 — Accure Laser System | Accure Acne, Inc. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240499 — ARTAIRA Arterial Compression Device (AACD01) | Airos Medical, Inc. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240472 — PBM Hair Therapy Cap | Dongguan Tutamen Metalwork Co., Ltd. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240242 — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | Anhui Deepblue Medical Technology Co., Ltd. Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230078 — Versius Surgical System | Cmr Surgical Limited Fri Oct 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240992 — eMVFit (MVF-10M) | Weero Co., Ltd. Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240315 — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | Siemens Healthcare Diagnostics Products GmbH Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241092 — Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT | Quanta System Spa Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241430 — EchoMeasure | Icardio.Ai Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240848 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance | Ambu A/S Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230325 — GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System | Greens Surgicals Pvt. , Ltd. Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241735 — ProSeal In Line Pump Set (423850) | Epic Medical Pte. , Ltd. Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241491 — Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid | Stryker Corporation (Tornier, S.A.S.) Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240262 — BTI Interna 3.0 Dental Implant System UnicCa® | B.T.I. Biotechnology Institute, Sl. Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233947 — KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System | Ctl Medical Corporation Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242389 — EyeGility Inserter for Preloaded enVista IOLs | Bausch & Lomb, Incorporated Thu Oct 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |