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Ambler Value Line
AMBLER SURGICAL CORP. · Model O'Sullivan-O'Connor self-retaining vaginal speculum · UDI-DI 00190660180386
HDF
Prescription
10
510(k) clearances
44
Adverse events
3
Recalls
227
Facilities
Description
O'Sullivan-O'Connor self-retaining vaginal speculum, complete set includes: frame, 2 lateral blades, and 3 center blades - 5/8'' x 1 3/4'', 1 1/2'' x 3 1/3'', and 1 3/4'' x 3 1/2''
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2023-03-16 | Carefusion 2200 Inc | A portion of the two products were incorrectly marked (etched) and packaged resulting in a product mismatch. The labels and laser etchings were switched on the two products. |
| 2019-07-01 | Centurion Medical Products Corporation | Potential for sterile packaging to be compromised |
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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.