Synaptic Medical Limited
FDA Regulatory Profile
Synaptic Medical Limited has 0 FDA recalls, 3 inspections, 7 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Mar 31, 2026 · VAI
- Latest 510(k)
- Sep 6, 2024
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 7 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 3 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233900 | Nordica PV Cryo Mapping Catheter | Sep 6, 2024 |
| K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230) | Jul 26, 2024 |
| K233708 | NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) | Feb 16, 2024 |
| K203793 | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | Feb 14, 2022 |
| K151936 | Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle | Dec 4, 2015 |
| K132943 | INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE | Aug 29, 2014 |
| K133028 | RITHM ID ELECTROPHYSIOLOGY CATHETER | Mar 4, 2014 |