FEI 3002806862

Dufner Instrumente Gmbh

FOEHRENSTR. 9, TUTTLINGEN Baden-Wurttemberg, DE

MDR events1All time

Recalls1All time

Registered products104

Establishment typeManufactureManufacture Medical Device

Registered product codes

104 product codes

Recent MDR events

1 on file

DE BAKEY SLIM NEEDLEHOLDER 23 CM TOP DURJun 18, 2020
Malfunction9612278-2020-00001

Recalls

1 on file

TerminatedUnknown
Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury
View FDA record ↗

Compliance history

Matched by FEI 3002806862.

FDA inspections

1 on file

No Action Indicated (NAI)Mar 13, 2024
Postmarket Assurance: Devices

Inspection citations

0 on file

No citations on file for this FEI number.

Compliance actions

0 on file

No warning letters or injunctions on file for this FEI number.

Import refusals

0 on file

No import refusals on file for this FEI number.