510(k) Clearances — Page 82
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243760 — OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO , Ltd. Thu Apr 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243936 — StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) | Staclear, Inc. Thu Apr 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242551 — syngo Dynamics (Version VA41D) | Siemens Healthcare GmbH Thu Apr 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240615 — Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. Thu Apr 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250138 — Small Volume 0.2mL Syringe | Prosum Medical Limited Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243659 — FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | SeaSpine Orthopedics Corporation Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242114 — Plum Solo Precision IV Pump | Icu Medical, Inc. Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243733 — SION blue PLUS | Asahi Intecc Co., Ltd. Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250930 — twiist system | Deka Research & Development Corp. Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241984 — Hi-D Imaging 4TAVR | Hi-D Imaging AG Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242113 — Nerve Wrap (07-DW-001-TAB) | Biocircuit Technologies, Inc. Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250705 — Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250613 — SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242067 — VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | Olympus Corporations of the Americas Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242460 — Progenix Select Stim | Progenix, LLC Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242115 — Plum Duo Precision IV Pump | Icu Medical, Inc. Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250760 — SPECTRUM GV Bone Cement | Osteoremedies, LLC Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242031 — Béa Applicator (BAP-GB-01) | Stepone Fertility Ltd (T/A Béa Fertility) Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242117 — LifeShield Infusion Safety Software Suite | Icu Medical, Inc. Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250677 — LEGION Total Knee System | Smith & Nephew, Inc. Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243889 — Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm) | Orthocell, Ltd. Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250152 — eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060; | Shenzhen TPH Technology Co., Ltd. Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250189 — AdvaTx | Advalight Aps Tue Apr 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250018 — Medical Diode Laser Systems (THEIA808) | Gigaalaser Company , Ltd. Tue Apr 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242427 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. Tue Apr 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242925 — MR Contour DL | GE Healthcare Tue Apr 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243938 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire | Scientia Vascular, Inc. Tue Apr 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242105 — SABA Tampons | Essity Higiene Y Salud Mexico. S.A. DE C.V. Tue Apr 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250623 — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. Tue Apr 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250578 — Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) | Careglove Global Sdn. Bhd. Tue Apr 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243072 — Préime DermaFacial (MicroT) | EMA Aesthetics , Ltd. Tue Apr 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242041 — STOPWET iontophoresis apparatus (SW01) | Taiwan Medical Electronics Co., Ltd. Tue Apr 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250946 — Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. Mon Mar 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250663 — Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. Mon Mar 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242166 — TribusConnect | Tribusmed Beheer BV Mon Mar 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243384 — Belzer UW® Cold Storage Solution (BTLBUW-001) | Bridge TO Life Mon Mar 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243178 — Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di | Shantou Institute of Ultrasonic Instruments Co., Ltd. Mon Mar 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250263 — Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. Mon Mar 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242618 — Layer 7-T | Precision Neuroscience, Corp. Sun Mar 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250601 — Neuro Omega System; NeuroSmart System | Alpha Omega Engineering , Ltd. Sun Mar 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240020 — Visby Medical Women's Sexual Health Test | Visby Medical, Inc. Fri Mar 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250571 — CATALYSTEM Femoral Stems | Smith & Nephew, Inc. Fri Mar 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244030 — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) | Wuxi Jiajian Medical Instrument Co., Ltd. Fri Mar 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242952 — INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH Fri Mar 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250596 — Arthrex FiberTak Suture Anchor | Arthrex, Inc. Fri Mar 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243520 — Bullsai Confirm | Turing Medical Technologies, Inc. Fri Mar 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233953 — Makani Science Respiration Monitoring System | Makani Science, Inc. Fri Mar 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244044 — PBC Separator with Selux AST System | Selux Diagnostics, Inc. Fri Mar 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241927 — Synthes Graphic Case & Tray System | Synthes GmbH Fri Mar 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243228 — Flexi-Seal AIR (with ENFit Connector) | Convatec Fri Mar 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |