Bellco Artifidial Organ Spec., Inc. FDA Record
- No warning letters matched by name
Bellco Artifidial Organ Spec., Inc. has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Bellco Artifidial Organ Spec., Inc." is on file.
- Latest 510(k)
- Dec 18, 1980
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 3 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 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 |
|---|---|---|
| K801633 | THE BRAVO NEW PARALLEL FLOW DIALYZER | Dec 18, 1980 |
| K801634 | THE VITA 2 DISPOSABLE DIALYZER | Dec 17, 1980 |
| K801632 | THE BELLCO FISTULA NEEDLES | Aug 4, 1980 |
Bellco Artifidial Organ Spec., Inc. and the FDA: common questions
Has Bellco Artifidial Organ Spec., Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Bellco Artifidial Organ Spec., Inc." 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 Bellco Artifidial Organ Spec., Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Bellco Artifidial Organ Spec., Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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