Ge Healthcare Technologies FDA Record
- No warning letters matched by name
Ge Healthcare Technologies has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Ge Healthcare Technologies" is on file.
- Latest recall
- Z-3171-2026 · Jul 31, 2026 · filed under Ge Healthcare
- Latest 510(k)
- Nov 23, 2005
Newer recall under related name Ge Healthcare: Jul 31, 2026, Z-3171-2026.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K051734 | GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART #… | Nov 23, 2005 |
| K042866 | AMX5 AND AMX5D MOBILE X-RAY SYSTEMS | Nov 2, 2004 |
Ge Healthcare Technologies and the FDA: common questions
Has Ge Healthcare Technologies received an FDA warning letter?
No FDA warning letter addressed to the name "Ge Healthcare Technologies" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Ge Healthcare Technologies received an FDA Form 483?
FDA has not published a Form 483 for "Ge Healthcare Technologies" in its reading room. FDA publishes some Form 483s, not all of them.
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