510(k) Clearances — Page 158
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K233013 — 2-Way 100% Silicone Cleartract Catheter | Silq Technologies Corporation Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232673 — Dental Glass Ceramics | Chengdu Besmile Medical Technology Co., Ltd. Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230841 — NailLift | Jps Corporation Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233887 — IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) | Shenzhen Ulike Smart Electronics Co., Ltd. Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233450 — MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw | Megagen Implant Co., Ltd. Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231423 — Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) | Shenzhen Roundwhale Technology Co. , Ltd. Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231299 — Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector | Cair Lgl Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234087 — restor3d TIDAL Lumbar Interbody Fusion System | Restor3D Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233105 — RESPONSE Rib and Pelvic System | OrthoPediatrics Corp. Sat Jan 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230817 — TORPEDO Implant System® | Deltacor GmbH Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232347 — MagnetOs Granules | Kuros Biosciences B.V Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233736 — LifeSPARC System | Cardiacassist, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231213 — HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231237 — BD Vacutainer® Fluoride Blood Collection Tubes | Becton, Dickinson and Company Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232679 — Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister | Argon Medical Devices, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232783 — Power wheelchair (Model: JMPW-01W) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231873 — DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional | Depuy Ireland UC Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233436 — IlluminOss Photodynamic Bone Stabilization System | Illuminoss Medical, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233461 — Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) | Hi-Dow International, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233728 — SIGNA Champion | Ge Healthcare (Tianjin) Company Limited Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231071 — Mix2Vial® Transfer Device | West Pharma. Services IL, Ltd. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230133 — Plenity | Gelesis, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220009 — VerTouch Spinal Imaging Device | Intuitap Medical, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231218 — Distal Access Catheter | Accumedical Beijing , Ltd. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233142 — EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232466 — Electric Breast Pump, model: YM-8166 | Guangdong Youmeng Electrical Technology Co., Ltd. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232156 — Rapid ASPECTS (v3) | Ischemaview, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230524 — Cold Compression Wrap Pro | Chengdu Cryo-Push Medical Technology Co.,Ltd Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232860 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | Pentax of America, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233190 — ENFit Adaptor | Jiangsu Caina Medical Co.,Ltd Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233451 — Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233077 — FlashHeal 2 (FlashHeal 2.0) | Inwound Aps Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234040 — TriMed Threaded Intramedullary Nail System | TriMed, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232698 — NemoScan | Software Nemotec S.L. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233242 — Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231573 — ThinkQA (Edition 2) | Dosisoft SA Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233213 — NxStage PureFlow Solution | Nxstage Medical, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233447 — CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234031 — Medline UNITE Ancillary Foot Recon Plating System | Medline Industires, LP Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234011 — AMF TT Cones | Lima Corporate S.P.A. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231860 — TDM Screw System | Tdm Co., Ltd. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234051 — Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 | Spinal Simplicity, LLC Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232373 — Progrip Self-Gripping Polypropylene Mesh | Sofradim Production Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232577 — Radial Compression Device | Ningbo Dizegens Medical Science Co.,Ltd Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231166 — Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes | Zmi Electronics , Ltd. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233744 — Curiteva Porous PEEK Lumbar Interbody Fusion System | Curiteva, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233507 — EVOLUTION® Tibial Cones | Microport Orthopedics, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221866 — S-Plant Dental Implant System | Newton Implant Systems, Inc. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231405 — Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode | Jiangsu Rong FU Kang Medical Instruments Co., Ltd. Thu Jan 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |