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ATRAUMATA

Aesculap AG · Model FC325T · UDI-DI 04046963460358

HXD Prescription
10
510(k) clearances
1,235
Adverse events
4
Recalls
336
Facilities

Description

GLOVER ATRAUMATA Vascular Clamp, curved, 10 5/8", (270 mm), toothing DE BAKEY, width: 80 mm, titanium, non-sterile, reusable

Recalls

DateFirmReason
2025-01-31Aesculap IncThe forceps have been used in ways not covered by the design resulting in breakage of the clamps.
2024-02-23MEDLINE INDUSTRIES, LP - NorthfieldProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
2018-05-04Stryker GmbHLaser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm
2015-06-16Symmetry Surgical, Inc.Lack of sterility assurance.

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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.