This company has registrations in United States, Brazil, Saudi Arabia, Canada, South Korea — 5 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 | K251448 | FL-10000U Respiratory Humidifier | 2026-01-16 |
| US | K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | 2025-05-20 |
| US | K201666 | SINGLE USE MANOMETER | 2020-11-13 |
| BR | 81027710002 | REANIMADOR MANUAL DESCARTÁVEL FLEXICARE | Class II |
| BR | 81027710003 | REANIMADOR MANUAL REUTILIZÁVEL FLEXICARE | Class II |
| BR | 80071260426 | BOLSAS DO RESERVATÓRIO DE SILICONE | Class II |
| SA | ME0000004607SFDAA00056 | Parallel Pediatric/Neonatal Circuit | — |
| SA | ME0000004607SFDAA00055 | Anesthesia Face Mask Silicone Reusable | — |