510(k) Clearances — Page 124
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241094 — Bullsai | Turing Medical Technologies, Inc. Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241699 — SUPER VELOCE | Ilooda Co,., Ltd. Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241429 — ECHELON Synergy MRI System | Fujifilm Healthcare Corporation Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241978 — Shinetell Digital Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240807 — VM-2000 | Ventis Medical, Inc. Tue Aug 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241846 — E3D-C Interbody System | Evolution Spine Mon Aug 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242054 — OptimMRI (v2) | Rebrain, Sas Mon Aug 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241402 — Medical Monitor (32HR734S) | Lg Electronics.Inc Mon Aug 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233367 — iDart Lyme IgG ImmunoBlot Kit | Id-Fish Technology, Inc. Mon Aug 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241656 — Eneka Selectif | Termosalud Mon Aug 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241365 — Pixie Pulse (SM9068) | Pixie Cup, LLC Mon Aug 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240868 — Ultravision2 IonPencil | Alesi Surgical Limited Mon Aug 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242096 — dS FootAnkle Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. Mon Aug 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN210037 — SoClean 3+ Bacterial Reduction Device | Soclean, Inc. Mon Aug 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241328 — aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X) | Carlsmed, Inc. Mon Aug 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241376 — HyperSuture All Blue Extension Line | Threadstone, LLC Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231950 — MEDIDIODE | Medicreations, LLC Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240664 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233697 — SonoMax Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222688 — The Trust | Genoss Co., Ltd. Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240079 — Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) | Suzhou Ideal Medical Co., Ltd. Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233643 — F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234053 — F&P Optiflow Flow Diverter | Fisher & Paykel Healthcare, Ltd. Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242016 — EnSite X EP System | ABBOTT MEDICAL Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232404 — CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES | Medicon Hellas S.A Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240469 — Access TPO Antibody | Beckman Coulter, Inc. Fri Aug 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233822 — i2Contour | Mrimath, LLC Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241665 — Omni Legend | Ge Medical Systems Israel, Functional Imaging Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233702 — SMARxT Tubing and Connectors | LivaNova USA, Inc. Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | Fisher & Paykel Healthcare, Ltd. Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240724 — SynthVISION 1.0.0 | Synthesis Health Intelligence, Inc. Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233356 — Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233720 — Luminopia | Luminopia, Inc. Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233315 — HipXpert and HipInsight System | Surgical Planning Associates, Inc. Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233312 — SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 | Aktormed GmbH Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240229 — Masimo W1 | Masimo Corporation Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242009 — 360CAS Knee | Kico Knee Innovation Company Pty, Ltd. Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233844 — OdneClean | Odne AG Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231775 — GR Resin System MSI | Pro3Dure Medical Thu Aug 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241685 — SofWave System | Sofwave Medical, Ltd. Wed Aug 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233606 — ADVIA Centaur EBV-VCA IgM | Biokit, S.A. Wed Aug 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240255 — Electric Wheelchair (JLE-W01A-2023) | Zhejiang Jianrui Technology Company Limited Wed Aug 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241530 — Stellar Imaging System | Guangdong Optomedic Technologies, Inc. Wed Aug 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241644 — SPINEART Navigation Instrument System | Spineart SA Wed Aug 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240605 — Ultra RapidWarm Blast | Vitrolife Sweden AB Wed Aug 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233605 — ADVIA Centaur EBV-EBNA IgG | Biokit, S.A. Wed Aug 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009) | Medtronic Wed Aug 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K212969 — Liposaver | Lhbiomed Co., Ltd. Wed Aug 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240330 — HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650) | O&M Halyard, Inc. Wed Aug 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241528 — Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential | Comfort Rubber Gloves Industries Sdn. Bhd. Tue Aug 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |