510(k) Clearances — Page 59
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K250315 — RONAVIS FX (FX-001) | AIRS, Inc. Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250381 — Deepsight NeedleVue LC1 Ultrasound System | DeepSight Technology, Inc. Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250541 — Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251707 — IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) | Shenzhen Huachuangtong Industrial Co., Ltd. Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243427 — QuickSleeper 5 | Dentalhitec Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250941 — Revolution Vibe | Ge Medical Systems, LLC Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243448 — Equinoxe® Shoulder System | Exactech, Inc. Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243496 — MycoMEIA Aspergillus Assay | Pearl Diagnostics, Inc. Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251652 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo | American Medical Endoscopy, Inc. Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250495 — MINI VP1 (PL67_F); MINI VP1 (PL61_F) | Avizor S.A. Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252094 — eZSURE Empty Fluid Container | Epic Medical Pte. , Ltd. Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243462 — Diazyme Colorimetric Lithium Assay | Diazyme Laboratories, Inc. Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr | Access Vascular, Inc. Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243483 — Access hsTnI | Beckman Coulter, Inc. Fri Aug 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243656 — U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | United Orthopedic Corporation Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250597 — REMEX Xcam6 | Remedi, Inc. Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250477 — NextAR(TM) Spine | Medacta International S.A. Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250738 — YSIO X.pree | Siemens Medical Solutions Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems | Roche Molecular Systems, Inc. Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242728 — BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244060 — eCO2 3D | Lutronic Corporation Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241461 — Mpact Constrained Liner | Medacta International S.A. Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251561 — Biograph Trinion | Siemens Medical Solutions USA, Inc. Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243341 — Genius AI Detection 2.0 | Hologic, Inc. Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251574 — Sleep Watch | Ambulatory Monitoring, Inc. Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240068 — ArteraAI Prostate | Artera, Inc. Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250843 — Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) | Shenzhen TPH Technology Co., Ltd. Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250724 — Intraosseous Infusion Needles | Spectrum Vascular Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243919 — Voxel Dosimetry (00859873006226) | Hermes Medical Solutions AB Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251319 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Extended Cuff | Hartalega NGC Sdn. Bhd. Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241990 — SpineSite Endoscope System | Hydrocision, Inc. Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252144 — Iconix Speed Anchor; Iconix Speed HA+ Anchor | Riverpoint Medical Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242855 — P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) | E.O.S Co., Ltd. Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251361 — Tyber Medical Distal Radius Plating System | Tyber Medical, LLC Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243534 — Micro Catheter | Suzhou Zenith Vascular SciTech Limited Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251060 — CORUS Navigation System-GX | Providence Medical Technology, Inc. Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251076 — Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) | Shenzhen Lifotronic Technology Co., Ltd. Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251234 — EnSite X EP System | ABBOTT MEDICAL Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251706 — TENS and EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244007 — ArteVu | Cardio Ring Technologies, Inc. Taiwan Branch Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250127 — TSK Syringe | Tsk Laboratory, Japan Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252032 — T65 (9016E061-) | Tonica Elektronik A/S Wed Jul 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251350 — BD Plastipak Syringe | Becton, Dickinson and Company Tue Jul 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250647 — SImmetry+ System | Sivantage Tue Jul 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243473 — PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS | Prognosys Medical Systems Private Limited Tue Jul 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250442 — da Vinci Surgical System, IS5000 | Intuitive Surgical, Inc. Tue Jul 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251664 — Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | Olympus Medical Systems Corporation Tue Jul 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251523 — Cios Spin | Siemens Medical Solutions USA, Inc. Tue Jul 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |