510(k) Clearances — Page 117
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K233807 — LumiVy Lumbar IBF System | Vy Spine, LLC Tue Sep 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241874 — Aspiration Catheter (2189) | Hobbs Medical, Inc. Tue Sep 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240013 — EchoGo Heart Failure (2.0) | Ultromics Limited Mon Sep 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241570 — Unity Total Knee System | Corin U.S.A. Limited Mon Sep 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240243 — EConsole2 | DRTECH Corporation Mon Sep 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241834 — IPL Hair Removal Device (BE932C, BE932D, BE932E) | Shenzhen Yang WO Electronic Co., Ltd. Mon Sep 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240061 — TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | Smith & Nephew, Inc. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240420 — NeuroField Analysis Suite | Neurofield, Inc. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242504 — Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233153 — Traus SSG10 Surgical System | Saeshin Precision Co., Ltd. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242223 — SuperSonic HepaVu | Supersonic Imagine Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | Nakanishi, Inc. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241825 — Microwave Ablation Antennas | Canyon Medical, Inc. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234129 — Ecomed Disposable Administration Sets | Ecomed Solutions, LLC Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242147 — Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | Alphatec Spine, Inc. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242650 — zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241821 — Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle | Sol-Millennium Medical, Inc. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234108 — ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) | Energy Resources International Co., Ltd. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240604 — MTONE EVO (MTONE EVO) | M&T S.R.L. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240722 — Derma-R Cream (Derma-R Cream) | Raya Pharmaceuticals, LLC Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241332 — aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240036 — PIUR tUS Infinity | Piur Imaging GmbH Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232670 — HiCardi+ H100 | MEZOO Co., Ltd. Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241465 — Midas Flowmeter; eAVS | Parker Hannifin Corporation Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242162 — Coconut Hybrid | Good Clean Love, Inc. Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242509 — HAnano InterFuse(R) Modular Interbody | Next Orthosurgical Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240183 — Star E900 Handpiece Series | Dentalez, Inc., Stardental Division Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234096 — MonoStereo | Medicaltek Co., Ltd. Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242167 — Sterile and Non-Sterile Ultrasonic Coupling Agent | Anhui Deepblue Medical Technology Co., Ltd. Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240901 — Stethophone | Sparrow Acoustics, Inc. Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241709 — Pectus Blu Support Bar System | Biomet Microfixation Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242478 — GF85 (models GF85-3P, GF85-SP) | Samsung Electronics Co., Ltd. Thu Sep 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233064 — Copra Supreme | Whitepeaks Dental Solutions GmbH Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241784 — Arrow® Nitinol Wire | Teleflex Medical Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234142 — TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231893 — LOWTEM Crystal 120 | Lowtem Co., Ltd. Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241123 — Perpak Sterilization Tyvek Pouch | Km Corp. Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | Terragene S.A. Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241424 — InnoCare Specialty Foley Catheter | Innocare Urologics, LLC Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234153 — EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) | Edgelife Technologies, LLC Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241769 — Response Ortho Metaphyseal Hinge Fixator System | Response Ortho Solutions, LLC Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement | Xelite Biomed , Ltd. Wed Sep 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240689 — Robin's Egg | Telebrands Corporation Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240373 — Air compression Leg Massager (MM0520, MM0521, MM0522) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240250 — 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240293 — STS | Techbopulm, Ltd. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240274 — PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233721 — KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241942 — TriMed Bridge Plates | TriMed, Inc. Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234132 — Medline Reusable Sterilization Wrappers | Medline Industries, LP Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |