This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel — 8 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 | K102242 | OSOM C. DIFFICILE TOXIN A/B TEST | 2010-12-21 |
| US | K092633 | OSOM INFLUENZA A&B TEST , MODEL PN190 | 2009-09-25 |
| US | K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | 2008-05-15 |
| CA | 8792 | HYLAFORM VISCOELASTIC (HYLAN B GEL) | Class IV |
| CA | 61795 | SEPRAGEL SINUS (HYLAN B GEL) | Class IV |
| CA | 64472 | HYLASHIELD (ELASTOVISCOUS HYLAN SHIELD) | Class IV |