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AESCULAP
AESCULAP, INC. · Model MD595 · UDI-DI 04046964582837
HHM
Prescription
10
510(k) clearances
92
Adverse events
4
Recalls
132
Facilities
Description
HANK Uterine Dilator, 9 3/4", (250 mm), 13/14 FR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-31 | CooperSurgical, Inc. | During the manufacturing process the devices were laser-marked with the incorrect part number. |
| 2024-07-31 | CooperSurgical, Inc. | During the manufacturing process the devices were laser-marked with the incorrect part number. |
| 2019-12-11 | Centurion Medical Products Corporation | Incomplete seals on the sterile package may compromise the sterility |
| 2016-10-28 | Hologic, Inc | Breach in sterile barrier compromising product sterility |
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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.