Home › NORTH EAST SCIENTIFIC INC › NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter
NORTH EAST SCIENTIFIC INC · Model R-420-006 · UDI-DI 00850044399079
QTF
Prescription
1
510(k) clearances
0
Adverse events
8
Recalls
1
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-29 | Northeast Scientific Inc. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| 2025-08-29 | Northeast Scientific Inc. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| 2025-08-29 | Northeast Scientific Inc. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| 2025-08-29 | Northeast Scientific Inc. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| 2025-08-29 | Northeast Scientific Inc. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| 2025-08-29 | Northeast Scientific Inc. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| 2025-08-29 | Northeast Scientific Inc. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
| 2025-08-29 | Northeast Scientific Inc. | Potential for breaches in the sterile barrier packaging, compromising sterility assurance. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.