This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 | K251596 | Lunderquist Extra Stiff Wire Guide | 2025-11-09 |
| US | K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) | 2025-06-11 |
| US | K233680 | Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava Filter | 2024-01-18 |
| BR | 10212990114 | MICROCATETER PARA INFUSAO | Class II |
| BR | 10212999031 | CATETER PARA INTRODUÇÃO DE TUBO DE TROCA ENDOTRAQUEAL FROVA | Class II |
| BR | 10212990095 | CATETER PARA TUBO DE TROCA ENDOTRAQUEAL | Class II |
| CA | 7474 | LAPAROSCOPIC INSUFFLATOR | Class II |
| CA | 10084 | MURDOCH INTRAOPERATIVE LAPARASCOPE LENS CLEANER | Class II |
| CA | 10088 | IRRIGATORS/ASPIRATORS | Class II |