This company has registrations in United States, Brazil, Israel, Russia — 4 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 | K083780 | SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 | 2009-03-23 |
| US | K001142 | AUDIO TECHNOLOGIES S:R.1 | 2000-06-23 |
| US | K974501 | DIGITAL TINNITUS MASKING SYSTEM | 1998-01-20 |
| BR | 80088060009 | Aspirador Cirúrgico de Fraizer de Uso Único | Class II |