Q'apel Medical, Inc.
4245 Technology Drive, Fremont, CA, US
Registered product codes
3 product codes
Recent MDR events
56 on file
- ZebraJul 31, 2026Malfunction3015614-2026-00024
- ZebraJul 27, 2026Malfunction3015614-2026-00021
- ZebraJul 27, 2026Malfunction3015614-2026-00022
- ZebraJul 27, 2026Malfunction3015614-2026-00023
- ZEBRAJun 24, 2026Malfunction3015614-2026-00020
- ZEBRAMay 28, 2026Malfunction3015614-2026-00019
- ZEBRAMay 26, 2026Injury3015614-2026-00018
- ZEBRAMay 21, 2026Injury3015614-2026-00017
- ZEBRAMay 15, 2026Malfunction3015614-2026-00016
- ZEBRAMay 7, 2026Malfunction3015614-2026-00015
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3020954126.
FDA inspections
2 on file
- Official Action Indicated (OAI)Aug 8, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Aug 8, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
7 on file
Top cited requirements
Compare to industry ↗21 CFR 820.25(b)Training - Lack of or inadequate procedures
121 CFR 820.30(c)Design input - documentation
121 CFR 820.30(f)Design verification - Lack of or inadequate procedures
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
121 CFR 820.40Procedures not adequately established or maintained
121 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
1
- 21 CFR 820.25(b)Aug 8, 2024
Training - Lack of or inadequate procedures
- 21 CFR 820.30(c)Aug 8, 2024
Design input - documentation
- 21 CFR 820.30(f)Aug 8, 2024
Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(i)Aug 8, 2024
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40Aug 8, 2024
Procedures not adequately established or maintained
- 21 CFR 820.50(a)(1)Aug 8, 2024
Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.198(a)Aug 8, 2024
Lack of or inadequate complaint procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.