FDA activity / New device listings
New device listings: the latest from FDA
Establishments listing new devices. About 179 a week over the last 4 weeks FDA has published, 72 of them from US companies. Latest: September 30, 2026.
179a week
72US companies a week
714in 4 weeks
Per week
Where
- Foreign establishments425
- US establishments289
The latest
| Date | Company | Product | Class | Where |
|---|---|---|---|---|
| Sep 30 | Applied BioCode, Inc. | BioCode Respiratory Pathogen Panel (RPP); BioCode… | Class II | Santa Fe Springs, CA |
| Sep 30 | Philips Ultrasound LLC | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti… | Class II | Reedsville, PA |
| Sep 30 | Guangdong Youmeng Electrical Technology… | Philips Avent Natural Care Hands-free Wearable Electric… | Class II | Foshan Guangdong, China |
| Sep 30 | Synergy Health Sterilisation UK Ltd | Prosthesis, Hip, Constrained, Cemented Or Uncemented,… | Class II | Berkshire Reading, United Kingdom |
| Sep 30 | Lords Mark Industries Ltd. | LordsMED T3 ELISA Test Kit; LordsMED Rinse; LordsMED ADA… | Class I, Class II | Daman and Diu Dadra and Nagar Haveli, India |
| Sep 30 | Suzhou Baili Medical Supplies Co.,LTD | Gown | Class II | Suzhou Jiangsu, China |
| Sep 30 | STRYKER EMEA Supply Chain Services | Tornier Perform Advanced Glenoid | Class II | Venlo Limburg, Netherlands |
| Sep 30 | Aligntech de Mexico S, de R. L. de C. V. | Invisalign System - Lite; Invisalign System -… | Class II | Cd. Juarez Chihuahua, Mexico |
| Sep 30 | Cgbio USA, Inc. | ANAX 5.5 SPINAL SYSTEM_SFN6570M; ANAX 5.5 SPINAL… | Class I, Class II | Irvine, CA |
| Sep 30 | Smith & Nephew Medical Ltd | RENASYS DYNAFLOW Kit | Class II | HULL East Riding of Yorkshire, United Kingdom |
| Sep 30 | Titanlinks Logistics LLC | Porcelain; Dental Cement | Class II | Newark, DE |
| Sep 30 | Worldwide Supplies Limited | Tube Tracheostomy And Tube Cuff | Class II | Hong Kong, Hong Kong SAR China |
| Sep 30 | Instrumentation Laboratory Spa | NOVA View; NOVA View Automated Fluorescence Microscope;… | Class II | Roncello Lombardy, Italy |
| Sep 30 | Apryse Software Corp. | MiPACS V5 | Class II | Charlotte, NC |
| Sep 30 | Soher Med Limited | Porcelain; Dental Cement | Class II | Hong Kong, Hong Kong SAR China |
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