Hebumedical GmbH FDA Record
- Latest inspection NAI · Nov 2, 2018
- No warning letters matched by name
Hebumedical GmbH has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Hebumedical GmbH" is on file.
- Latest inspection
- Nov 2, 2018 · NAI
- Latest 510(k)
- May 14, 2013
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | 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 FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 2, 2018 | Tuttlingen, Germany | Devices | No Action Indicated (NAI) | 3008782585 |
| Jun 2, 2016 | Tuttlingen, Germany | Devices | Voluntary Action Indicated (VAI) | 3008782585 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008782585 | Tuttlingen, Germany | 2 | Nov 2, 2018 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K123077 | VASCULAR CLAMPS | May 14, 2013 |
Hebumedical GmbH and the FDA: common questions
Has Hebumedical GmbH received an FDA warning letter?
No FDA warning letter addressed to the name "Hebumedical GmbH" 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 Hebumedical GmbH received an FDA Form 483?
FDA has not published a Form 483 for "Hebumedical GmbH" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Hebumedical GmbH?
The most recent FDA inspection on file ended Nov 2, 2018 at Tuttlingen, Germany and was classified NAI. FDA has 2 inspections of Hebumedical GmbH on file.
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