510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Dufner Instrumente GmbH

TUTTLINGEN Baden-Wurttemberg, DE

DUFNER INSTRUMENTE GMBH appears in FDA device records in TUTTLINGEN Baden-Wurttemberg, DE. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Dufner Instrumente GmbH in 2001.

Clearances by year, as a table
510(k) clearance decisions for Dufner Instrumente GmbH, by decision year
YearClearances
20011
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K002877MICTEC ENDOSCOPES AND ACCESSORIESGEISubstantially Equivalent

Registered establishments

FDA registered establishments for Dufner Instrumente GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96122783002806862DUFNER INSTRUMENTE GMBHFOEHRENSTR. 9, TUTTLINGEN Baden-Wurttemberg 78532 DE2026and 94 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2534-2020DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23Tungsten 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 injuryClass IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain