K984576

Substantially Equivalent

K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K

Applicant: Terumo Europe N.V.
Product code: FMI
Advisory panel: General Hospital
Date received: 1998-12-23
Decision date: 1999-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.