FEI 3001726808Initial importer
Acist Medical Systems, Inc.
7905 FULLER ROAD, EDEN PRAIRIE, MN, US
MDR events403All time
Recalls0All time
Registered products9
Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198
Registered product codes
9 product codes
Recent MDR events
403 on file
- EMPOWER CTAJul 21, 2026Injury2134243-2026-00013
- ACISTJul 1, 2026Injury2134243-2026-00012
- ACISTJun 2, 2026Injury2134243-2026-00011
- ACISTApr 16, 2026Injury2134243-2026-00010
- ACISTApr 14, 2026Injury2134243-2026-00009
- ACISTApr 7, 2026Injury2134243-2026-00008
- ACISTMar 17, 2026Injury2134243-2025-00021
- ACISTMar 13, 2026Injury2134243-2026-00007
- ACISTMar 9, 2026Injury2134243-2026-00006
- ACISTFeb 24, 2026Injury2134243-2026-00005
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3001726808.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
1 on file
Top refusal reasons
Compare to industry ↗- Division of Southeast Imports (DSEI)May 17, 2024
80PUR \ VACUUM SYRINGE