510(k) Clearances — Page 163
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K233782 — SmoothSkin Pure Adapt (SSG3) | Cyden Limited Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233492 — EMS Neck Massager | Xiamen Comfier Technology Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233839 — Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT Intervertebral body fusion system; The Peridot-TD Anterior Cervical Intervertebral body fusion system; The Peridot-TD Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230736 — MagnetOs Putty | Kuros Biosciences B.V Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233130 — Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233176 — uOmnispace.MI | Shanghai United Imaging Healthcare Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230850 — United Orthopedic Knee Patient Specific Instrumentation | Enhatch, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231402 — HP PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231660 — Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230955 — syngo Application Software | Siemens Medical Solutions USA, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231227 — SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | Baylis Medical Company, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231411 — INNO SLA Submerged Hybrid Ti-Base System | Cowellmedi Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232444 — Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231780 — Perifit Care+ | X6 Innovations Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230855 — BD Vacutainer® Serum Separator (SST) Blood Collection Tubes | Becton, Dickinson and Company Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232286 — Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | Quidel Corporation Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231556 — SPECTRUM® GV Bone Cement | Osteoremedies, LLC Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230545 — Inessa System | Triple Jump Israel , Ltd. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232736 — Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test | Chemtron Biotech, Inc. Wed Dec 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233448 — Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | Integra Lifesciences Production Corporation Tue Dec 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222810 — TD-7301 Peak Flow meter | Gostar Co., Ltd. Tue Dec 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231671 — IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) | Philips Medizin Systeme Boeblingen GmbH Tue Dec 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230840 — PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. Tue Dec 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233163 — ZENEX Implant System_Short | Izenimplant Co., Ltd. Tue Dec 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232560 — Angled Abutment | Arum Dentistry Co., Ltd. Tue Dec 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221199 — Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) | Green Island International Tcm Group Limited Tue Dec 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231526 — CORAIL Cemented Femoral Stem | Depuy Ireland UC Tue Dec 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232458 — JETiHydrodynamic Thrombectomy System | ABBOTT MEDICAL Tue Dec 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233551 — GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. Tue Dec 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233470 — DEKA LILY | El.En S.P.A. Tue Dec 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233132 — PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC Tue Dec 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231587 — MAGNETOM Cima.X | Siemens Medical Solutions USA, Inc. Mon Dec 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231066 — CuratOR EX3242-FD | Eizo Corporation Mon Dec 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232984 — Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. Mon Dec 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231929 — iQ-solutions | Sydney Neuroimaging Analysis Centre Pty, Ltd. Mon Dec 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222846 — AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. Mon Dec 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232780 — CC-Clip® Implant System | Cc-Instruments, Inc. Mon Dec 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232847 — SiOxD Wound Matrix | Sioxmed, LLC Mon Dec 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231429 — S-Plant Dental Implant System | Idis Co., Ltd. Mon Dec 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222881 — Access hsTnI | Beckman Coulter, Inc. Mon Dec 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233815 — ClotTriever Sheath | Inari Medical, Inc. Mon Dec 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233691 — FlexCath Cross Transseptal Solution | Acutus Medical, Inc. Sun Dec 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233536 — Air Compression Recovery System | Shenzhen Dongjilian Medical Tech Co., Ltd. Sat Dec 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231825 — Panther TPS | Prowess, Inc. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232384 — Videa Dental Assist | Videahealth, Inc. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230926 — Ova+ (K-OVAP-USA) | Tenscare, Ltd. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232394 — Internal Locking Plate and Screw Fixation System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233668 — Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) | Eximo Medical, Ltd. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232095 — SeptiCyte RAPID | Immunexpress, Inc. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232892 — Hp Detect Stool Antigen ELISA | Biomerica, Inc. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |