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Bioteque America, Inc.

Bioteque America, Inc. · Model DT-B · UDI-DI 00810142352307

HDX Prescription
1
510(k) clearances
4
Adverse events
1
Recalls
19
Facilities

Description

Vaginal Dilator set-B, SET DT-B

Recalls

DateFirmReason
2015-06-19CooperSurgical, Inc.Incorrect expiration date on outer carton kit label

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Data 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.