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Ambler Surgical

AMBLER SURGICAL CORP. · Model Bellucci-Wullstein self-retaining retractor · UDI-DI 00190660131685

FFO Prescription
5
510(k) clearances
86
Adverse events
3
Recalls
152
Facilities

Description

Bellucci-Wullstein self-retaining retractor, 5'', 2 blunt prongs on right shaft, 13.0mm long, solid 10.0mm x 20mm blade on left shaft, 45.0mm spread, ring handle with ratchet catch

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2015-11-25Abeon Medical CorporationThe firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
2015-11-25Abeon Medical CorporationThe 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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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.