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Novo Surgical Inc.
NOVO SURGICAL, INC. · Model E8477-15 · UDI-DI 00842331179754
KCG
Prescription
1
510(k) clearances
21
Adverse events (4 deaths)
1
Recalls
87
Facilities
Description
laborde tracheal dilator, 3 blades, 2 flat, 1 cupper, child, 5 1/8" (13.0 cm)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
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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.