510(k) Clearances
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,607 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K261675 — CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) | Shenzhen Chuanghong Zhilian Technology Co., Ltd. Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261984 — AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253011 — Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250040 — SportSuite Vision Software | Stryker Endoscopy Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253963 — Cubresa BrainPET | Cubresa, Inc. Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253694 — Natural Cycles | Natural Cycles Nordic AB Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260694 — ZEISS CLINIC 360 | Carl Zeiss Meditec, AG Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261475 — BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | Biofire Defense, LLC Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251952 — Virasight | Virasoft Corporation Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261693 — Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261046 — Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261614 — LED LCD Monitor (OEV-271H) | Lg Electronics.Inc Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254006 — Drivewire 35 Guidewire | Rapid Medical Ltd. Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261658 — LoFric Origo Pro Coudé | Wellspect AB Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM | Stryker Spine Fri Jul 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261706 — Endomat Select (UP220) | KARL STORZ SE & CO. KG Thu Jul 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261309 — Palisades Buttress Plate System | Bethesda Medical Devices, LLC Thu Jul 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260021 — cobas® BV/CV | Roche Molecular Systems, Inc. Thu Jul 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K262032 — TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. Thu Jul 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter) | Scientia Vascular, Inc. Thu Jul 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261271 — Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. Thu Jul 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261674 — Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. Thu Jul 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K262030 — Aventus Thrombectomy System | Inquis Medical Wed Jul 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | Kyocera Medical Technologies, Inc. Wed Jul 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260338 — ThinkSono Guidance | ThinkSono GmbH Wed Jul 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253606 — NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. Wed Jul 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260050 — WRAP System | Huneo, LLC Wed Jul 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252822 — Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant | Atlas Spine, Inc. Wed Jul 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260851 — Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. Wed Jul 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260739 — Profoject Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. Wed Jul 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260206 — SkeletonPlanner | UPlanner B.V. - Presurgeo Wed Jul 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261407 — XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) | Dongguan Miqiang Technology Co., Ltd. Wed Jul 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K262006 — EnSite X EP System | Abbott Medical Wed Jul 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253662 — LIXI (LXOSFM1) | Luwi, LLC Tue Jul 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) | Ambu A/S Tue Jul 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261249 — Universal Seal (5-12 mm) | Intuitive Surgical, Inc. Tue Jul 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261020 — Symmetrix L Spinal System | Medtronic Sofamor Danek USA, Inc. Tue Jul 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261633 — VisuBreath | Affirm Medical Technologies II, LLC Tue Jul 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253667 — Accoat Guide Wire | Sp Medical A/S Tue Jul 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System | Alphatec Spine, Inc. Tue Jul 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261232 — IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. Tue Jul 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253504 — Volnewmer | Classys, Inc. Mon Jul 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260199 — SLIM Microcatheter | Balt USA, LLC Mon Jul 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254044 — Hearing assist | Meta Platform Technologies, LLC Mon Jul 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261199 — Wearable Breast Pump (Model S32A) | Shenzhen TPH Technology Co., Ltd. Mon Jul 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261085 — Rapid Vessel Occlusion (Rapid VO) | iSchemaview Mon Jul 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire | Merit Medical Ireland , Ltd. Mon Jul 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260208 — Ultra-Fine SAFETY Insulin Syringe | embecta Medical II, LLC Mon Jul 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261031 — POSEIDON ST | Signus Medinzintechnik GmbH Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261149 — Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
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