Catalysts for Bayer USA LLC
10 tracked
Jan 30, 2026
device pma
Balt USA, LLC — SQUID Liquid Embolic Agent (LEA) (PMA)
Bayer USA LLC
→
Jan 27, 2026
device 510k
Balt USA, LLC — Optima Coil System (OptiOne Coil System) (510k cleared)
Bayer USA LLC
→
Oct 24, 2025
approval
LYNKUET (ELINZANETANT) — FDA approval
Bayer USA LLC
→
Oct 22, 2025
device 510k
Balt USA, LLC — Carrier XL Delivery Catheter (510k cleared)
Bayer USA LLC
→
Sep 26, 2025
device 510k
Balt USA, LLC — Optima Coil System (Optima Packing Coil System) (510k cleared)
Bayer USA LLC
→
Sep 25, 2025
device recall
BALT USA, LLC device recall (Cls I)
Bayer USA LLC
→
Jun 3, 2025
device 510k
Balt USA, LLC — Raptor Aspiration Catheter; Balt Aspiration Tubing Set (510k cleared)
Bayer USA LLC
→
May 30, 2025
device 510k
Balt USA, LLC — Prestige Coil System (Prestige Packing Line Extension) (510k cleared)
Bayer USA LLC
→
Dec 30, 2024
device 510k
Balt USA, LLC — Next Generation Access Platform (510k cleared)
Bayer USA LLC
→
Sep 27, 2024
device 510k
Balt USA, LLC — Optima Coil System (OptiBlock Line Extension) (510k cleared)
Bayer USA LLC
→