510(k) Clearances — Page 104
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243447 — Rapid Surgical Plan (RSP-SW-001) | Navbit Pty, Ltd. Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242653 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL | Thermo Fisher Scientific Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242525 — iTOF® | Nerbio Medical Software Platforms, Inc. Thu Dec 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242185 — Rextar Pro | Raypia Co., Ltd. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242686 — Neodent Implant System | Jjgc Indústria E Comércia DE Materiais Dentários S.A. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242831 — Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242395 — Nanox.ARC | Nano-X Imaging , Ltd. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243180 — SSPC NXT Delivery Catheter | CenterPoint Systems, LLC Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240671 — XBeam (v2) | Xstrahl, Ltd. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242301 — Socrates 38 Catheter | Scientia Vascular, Inc. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243417 — RelieVRx | Appliedvr Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242348 — Locking Screw,CoCrMo | Double Medical Technology, Inc. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242184 — Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); | Alcon Laboratories, Inc. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243265 — Ion 3D | SurGenTec, LLC Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241197 — DeepRhythmAI | Medicalgorithmics S.A. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242685 — Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243475 — Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242643 — CapsoCam Plus (SV-3) Capsule Endoscopy System | CapsoVision, Inc. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Osteonic Co., Ltd. Tue Dec 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242188 — ClearRead CT CAC | Riverain Technologies, Inc. Tue Dec 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241486 — Sofsilk Coated Braided Silk Suture | Covidien Tue Dec 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242861 — TrueLok Elevate | Orthofix Srl Tue Dec 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243470 — Fix2Lock (PEEK Self Punching) | Osteonic Co., Ltd. Tue Dec 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243454 — Verruca-Freeze H | Cryosurgery, Inc. Tue Dec 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243418 — Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242619 — GroWell BT Hair Growth System (GW10042) | Apira Science, Inc. Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243020 — MIDASVu | Intravu, Inc. Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223120 — Ventoux VC2; Ventoux VC3 | Flight Medical Innovations , Ltd. Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243232 — GripMate | Synthon Hispania S.L. Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240475 — Hintermann Series H2 Total Ankle System | Vilex, LLC Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241871 — Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System | STERIS Corporation Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242225 — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. Fri Nov 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243375 — Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine Fri Nov 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241628 — YO Home Sperm Test | Medical Electronic Systems , Ltd. Fri Nov 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241090 — Evie Med Ring | Movano Inc. Dba Movano Health Fri Nov 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241115 — SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter | Spectrum Vascular Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242187 — BioBrace® | Conmed Corporation Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242444 — HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243362 — SmoothSkin Pure Switch (SSC1) | Cyden Limited Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243354 — Remunity System | Deka Research & Development Corp. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242638 — LED Light Therapy Machine (G1, G3, G4, G6) | Shenzhen Walton Technology Co., Ltd. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243221 — RadiForce RX570; RadiForce RX570-AR | Eizo Corporation Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243355 — Ceragem Automatic Thermal Massager (CGM-MB-1902) | Ceragem Co., Ltd. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240994 — Nexpowder | Nextbiomedical Co., Ltd. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243409 — KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | Karl Storz SE & CO. KG Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233273 — C&B Ceramic; C&B Permanent; C&B Interim | Prevest Denpro Limited Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243408 — TACTIX Vector Syndesmosis System | Vilex, LLC Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242796 — CryoGlow (FW3XXXX) | Sharkninja Operating, LLC Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241353 — PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set | Bard Access Systems, Inc. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |