510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Dannoritzer Medizintechnik GmbH & Co. KG

Amsterdam, NL

Dannoritzer Medizintechnik GmbH & Co. KG appears in FDA device records in Amsterdam, NL. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

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

510(k) clearance history

FDA records hold 1 510(k) clearance for Dannoritzer Medizintechnik GmbH & Co. KG in 2006.

Clearances by year, as a table
510(k) clearance decisions for Dannoritzer Medizintechnik GmbH & Co. KG, by decision year
YearClearances
20061
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K052759DAN MONOPOLAR LAP ACCESSORIESGEISubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0062-2019Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulationThe Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.Class IIITerminated

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