510(k) Clearances — Page 139
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240482 — Intense Pulsed Light System (ST-690) | Smedtrum Medical Technology Co., Ltd. Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233933 — CIRRUS HD-OCT Model 6000 | Carl Zeiss Meditec, Inc. Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220891 — Kahook Dual Blade Glide (KDB Glide) | New World Medical, Inc. Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240935 — ARENAL Anterior Cervical Plate System | Effortmed, LLC Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233215 — icotec Anterior Cervical Plate System | Icotec AG Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232525 — Yoni.Fit Bladder Support | Watkins-Conti Products, Inc. Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241175 — MiRus MoRe Lumbar Plating System | MiRus, LLC Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230035 — DentalMonitoring | Dental Monitoring Sas Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233209 — uOmnispace.CT | Shanghai United Imaging Healthcare Co., Ltd. Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232516 — Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233236 — Radiance V5 | Gmv Soluciones Globales Internet S.A.U. Fri May 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232786 — Stimulation System (PA series, PR series, S series and Q series) | Edan Instruments, Inc. Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) | Reshape Lifesciences Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233841 — HD80 Series Ultrasound Diagnostic System | Qingdao Hisense Medical Equipment Co., Ltd. Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233473 — DEKA LOTUS | El.En S.P.A. Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233137 — Ticare Dental Implant Systems | Mozograu S.A. Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240328 — eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240445 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. | Thermo Fisher Scientific Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240752 — DEKA TORO | El.En S.P.A. Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230711 — Pain Therapy Device(Model: P.T.S-X) | Guangzhou Xinbo Electronic Co., Ltd. Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233625 — RAYDENT SW | Ray Co., Ltd. Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232849 — Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) | Owens & Minor (O&M) Halyard, Inc. Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232542 — Wedge XL Delivery Catheter | MicroVention, Inc. Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232933 — AirKEE P900 | Healkee Medical Pte, Ltd. Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240386 — Picosecond Nd:YAG Laser Systems (BL-C10) | Shanghai Bele Medical Technology Co.,Ltd Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240059 — FAgamin® | Tedequim Srl Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232495 — Sempulse Halo Vital Signs Monitor | Sempulse Corporation Thu May 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241049 — CANON Fundus Camera CR-10 (CR-10) | Canon, Inc. Wed May 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233247 — Heuron ICH | Heuron Co., Ltd. Wed May 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231940 — BruxZir® NOW SRC | Prismatik Dentalcraft, Inc. Wed May 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240278 — Full Wedge Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. Wed May 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241053 — MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL | Medtronic Cardiac Surgery Wed May 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241043 — Augment Off-Axis Instrument System | Fix Surgical Wed May 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230043 — Notal Vision Home Optical Coherence Tomography (OCT) System | Notal Vision, Inc. Wed May 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241112 — BriefCase-Quantification | Aidoc Medical , Ltd. Wed May 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233985 — TRIUX neo (NM27000N ); MEGreview (SW26241N-B) | Megin OY Wed May 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240368 — E3D-A Interbody System | Evolution Spine Wed May 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240426 — Aventus Clot Management System | Inquis Medical Tue May 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233913 — Electric Breast Pump (BRP-301); Electric Breast Pump (BRP-302); Electric Breast Pump (BRP-303); Electric Breast Pump (BRP-304); Electric Breast Pump (BRP-305); Electric Breast Pump (BRP-306); Electric Breast Pump (BRP-307); Electric Breast Pump (BRP-308) | Aoj Health Technology Co., Ltd. Tue May 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232662 — BNLE Hydrophilic Jacketed Peripheral Guidewire | Biomerics Nle Tue May 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232242 — BEAR 2 Body | Foreo, Inc. Mon May 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232529 — Disposable Double Lumen Endobronchial Tube | Shenzhen Insighters Medical Technology Co., Ltd. Mon May 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233875 — Brainomix 360 e-Lung | Brainomix Limited Mon May 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232614 — Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) | Sri Trang Gloves (Thailand) Public Company Limited Mon May 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232862 — MIM Monte Carlo Dosimetry | Mim Software, Inc. Mon May 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240759 — REMEX-GR100 | Remedi Co., Ltd. Mon May 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240658 — 1060nm laser body slimming machine | Hebei JT Medical Co., Ltd. Mon May 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240949 — Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine) | Healgen Scientific,, LLC Mon May 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234023 — Oocyte Flushing & Retrieval Medium; Gamete Buffer | Gimbo Medical Technology Shenzhen Co., Ltd. Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) | Fresenius Medical Care Renal Therapies Group, LLC Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |