510(k) Clearances — Page 3
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,607 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K260755 — OptraSCAN System | Optrascan, Inc. Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN250034 — Claria System | Claria Medical, Inc. Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260596 — Collagen Wound Powder | Ventris Medical Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253704 — iPredict-DR | iHealthscreen, Inc. Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261587 — Insufflation Retention Device (IRD) (11173-325-101) | BPEndo, LLC Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261847 — iTero Lumina Pro | Align Technology , Ltd. Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260528 — OncoStudio | Oncosoft. Inc., Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252243 — Fastplex BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261867 — Xpert Carba-R | Cepheid® Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253884 — Koios DS (3.8) | Koios Medical, Inc. Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260527 — FACE4D Aligner | Avinent Implant System S.L.U. Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261129 — OrthoFit | Spident Co., Ltd. Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253463 — ILR ECG Analyzer (IM007) | Implicity, Inc. Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261880 — FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | Fujifilm Corporation Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261852 — OTS Hip | Ortoma AB Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261054 — RibPlate System | Stryker Leibinger GmbH & Co KG Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261485 — Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy | SeaSpine Orthopedics Corporation Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261889 — Trevo Trak 21 Microcatheter | Stryker Neurovascular Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K262228 — Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261474 — DENTCA Tru Flexible | Dentca, Inc. Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260556 — Veritas Shoulder System | Restor3D Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261147 — Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252483 — Enteral Syringe (20ml, 60ml) | Chirana T.Injecta,A.S. Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253527 — Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | Covidien, LLC Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261473 — Chromix | Termosalud S.L. Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253434 — OSSTM Orthopedic Salvage System | Biomet, Inc. Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261021 — EasyWhip Family | Winter Innovations, Inc. Wed Jul 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261068 — Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000) | Serpex Medical Tue Jun 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253767 — UB ERP System | Universal Brain Tue Jun 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261119 — NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. Tue Jun 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261808 — ISAAC Neurovascular Navigation Catheter | Microvention Inc. d/b/a Terumo Neuro Tue Jun 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260576 — MeVis AVM Contour | MeVis Medical Solutions AG Tue Jun 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261101 — Ceribell Monitor | Ceribell, Inc. Tue Jun 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K262195 — Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy Tue Jun 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261461 — Omnipod 6 algorithm | Insulet Corporation Mon Jun 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261052 — LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) | Guangdong Newdermo Biotech Co., Ltd. Mon Jun 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251492 — Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. Mon Jun 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K260667 — Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Mon Jun 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261415 — Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. Mon Jun 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K254149 — Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) | Sterilmed, Inc. Mon Jun 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K261481 — Pangea Femur Reconstruction System | Stryker GmbH Mon Jun 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253969 — ADAS 3D | Adas3D Medical S.L. Mon Jun 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253628 — Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) | Agada Medical, Ltd. Mon Jun 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K253484 — LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation Mon Jun 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |