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BV Medical · Model 61-600-010 · UDI-DI 00845821026484
1
510(k) clearances
4
Adverse events
1
Recalls
37
Facilities
Description
Otoscope Specula Variety Pack: 25 each of 2.5, 3.0, 4.0, 5.0 (Black, Latex Free)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-28 | Integra LifeSciences Corp. | Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition. |
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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.