Alembic, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Alembic, LLC - FDA 510(k) Cleared Devices
Recent clearances: APRO 45 Catheter, APRO 45 Catheter and Alembic Aspiration Tubing, APRO 55 Intermediate Catheter
10
Total
10
Cleared
0
Denied
Alembic, LLC has 10 FDA 510(k) cleared neurology devices. Based in Mountain View, US.
Latest FDA clearance: May 2025. Active since 2023.
Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Alembic, LLC
10 devices
Cleared
May 01, 2025
APRO 45 Catheter
Neurology
29d
Cleared
Apr 30, 2025
APRO 45 Catheter and Alembic Aspiration Tubing
Neurology
28d
Cleared
Apr 29, 2025
APRO 55 Intermediate Catheter
Neurology
29d
Cleared
Apr 28, 2025
APRO 55 Swift Catheter and Alembic Aspiration Tubing
Neurology
28d
Cleared
Feb 24, 2025
APRO 70 Swift Catheter and Alembic Aspiration Tubing
Neurology
129d
Cleared
Jan 14, 2025
APRO 70 Swift Catheter
Neurology
88d
Cleared
Mar 15, 2024
APRO 55 Catheter
Neurology
79d
Cleared
Feb 29, 2024
APRO 55 Catheter and Alembic Aspiration Tubing
Neurology
161d
Cleared
Apr 10, 2023
APRO 70 Catheter and Alembic Aspiration Tubing
Neurology
28d
Cleared
Feb 17, 2023
APRO 70 Catheter and Alembic Aspiration Tubing
Neurology
84d