This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K123916 | PSA SERIES | 2013-04-09 |
| US | K082242 | ICON, MODEL C3 | 2008-10-08 |
| US | K081035 | AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 | 2008-05-30 |
| CA | 60750 | PACEMAKER,EXTERNAL,TEMPORARY,DUAL CHAMBER, MODEL PACE 203H | Class IV |