Atlas FDA

BALT USA, LLC

6 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch BALT USA, LLC

RecordFirmDate
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog N recall (Z-0188-2026)BALT USA, LLC2025-10-24
Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 0081006856888 recall (Z-1988-2025)BALT USA, LLC2025-06-18
Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810 recall (Z-1989-2025)BALT USA, LLC2025-06-18
Neurovascular embolization device. The Optima Coil System is a series specialized coils th recall (Z-1041-2024)BALT USA, LLC2024-02-08
The Prestige Coil System is a product family of embolic coils with associated delivery sys recall (Z-1042-2024)BALT USA, LLC2024-02-08
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovas recall (Z-0103-2023)BALT USA, LLC2022-10-20

Track BALT USA, LLC automatically

Every clearance here is in the API, with alerts when new ones post.