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Novo Surgical Inc.
NOVO SURGICAL, INC. · Model UR6185-31 · UDI-DI 00842331151040
FFO
Prescription
5
510(k) clearances
86
Adverse events
3
Recalls
152
Facilities
Description
smith-buie rectal retractor, self-retaining, w/ swivel blades, blade size 23.0 mm x 70.0 mm, spread 4 1/2" (11.5 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. |
| 2015-11-25 | Abeon Medical Corporation | The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. |
| 2015-11-25 | Abeon Medical Corporation | The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. |
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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.