FDA applicant
Transamerican Technologies Intl.
FDA records 4 decisions for Transamerican Technologies Intl. (Pleasanton, CA) from 1987 to 1997: 4 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and GCJ (Laparoscope, General & Plastic Surgery). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Transamerican Technologies Intl.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Transamerican Technologies Intl. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Transamerican Technologies Intl.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Transamerican”
FDA records each applicant name separately; these may or may not be the same firm.