510(k) Clearances — Page 166
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K232517 — Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) | Shenzhen Kentro Medical Electronics Co., Ltd. Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231898 — DTX Studio Clinic (4.0) | Nobel Biocare AB Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232515 — Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223757 — Bonelogic | Disior, Ltd. Fri Dec 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233429 — OTS 25 (100-1) | Ots Medical , Ltd. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232381 — LOGIQ Totus | GE Medical Systems Ultrasound and Primary Care Diagnostics Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231967 — ARi ExCon Implant System | Megagen Implant Co., Ltd. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232761 — ProNephro AKI (NGAL) | Bioporto Diagnostic, Inc. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232273 — RM Electrode (RMH 23-01) | Retmap, Inc. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232795 — Led Mask Platinum Exclusive MD | Stg24 Co., Ltd. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231515 — MySpine Cervical Guides | Medacta International S.A. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231206 — DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232846 — Light Based Hair Removal Device | Shenzhen Meik Beauty Industry Co., Ltd. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231127 — S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232661 — Myocardial Strain Software Application | Circle Cardiovascular Imaging Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230137 — Reliance® Fusion Sterilization Wraps | Ahlstrom-Munksjo Nonwovens, LLC Thu Dec 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233334 — Aquilion Serve SP (TSX-307B/1) V1.3 | Canon Medical Systems Corporation Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233562 — LINQ II Insertable Cardiac Monitor | Medtronic, Inc. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231465 — Q-Pad Test System | Qurasense Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231125 — 2008T BlueStar Hemodialysis Machine | Fresenius Medical Care Renal Therapies Group, LLC Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231675 — OneRF Ablation System | Neuroone Medical Technologies Corp. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230677 — Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) | Cork Medical Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232206 — SOMATOM Pro.Pulse | Siemens Medical Solutions USA, Inc. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233521 — QT ECG (QTERD100) | QT Medical, Inc. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222930 — Evolve Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233042 — Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Shandong Intco Medical Products Co, Ltd. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232769 — BeaMed Laser Surgery Fibers | Bt Beamedical Tachnoogies Ltd. (Beamed) Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233597 — Sonosite LX Ultrasound System | FUJIFILM Sonosite, Inc. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230712 — SG Lanset I, SG Lancets, Soft Lancets | Sewon Medical Co. Wed Dec 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231615 — Disposable Endoscopic Bipolar | Jiangsu Hope Biomedical Science & Technology Co., Ltd. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232814 — Electronic Blood Pressure Monitor | Zhuhai Yueja Medical Device Technology Co., Ltd. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222057 — THERMOCLICK | T&R BIOFAB CO., Ltd. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232220 — SS Abutment System | Osstem Implant Co., Ltd. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230734 — Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) | Precision Healing, LLC Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit | Bd Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231005 — Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2 | Supermax Healthcare Canada-Supermax Medical Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233490 — SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty | Bioventus, LLC Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231230 — Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223170 — Electronic Blood Pressure Monitor, model: HTD6602US | Hetaida Technology Co., Ltd. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233568 — Ceevra Reveal 3+ | Ceevra, Inc. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231923 — Liberty SI Lateral Implant System | Spinal Simplicity, LLC Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232440 — Adravision Perio | Adra Corporation Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233335 — Tablo® Hemodialysis System | Outset Medical, Inc. Tue Dec 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232308 — Monarch Blood Collection Set | The Monarch Company Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230648 — Access hsTnI | Beckman Coulter, Inc. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232693 — Tyber Medical Distal Radius Plating System | Tyber Medical, LLC Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223783 — cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233347 — Verruca-Freeze® H | Cryosurgery, Inc. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220525 — RESPONDER Polysaccharide Hemostat | Starch Medical, Inc. Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Novastep Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |