JAMES TENDOS (SYRINGE HOLDER)— 510(k) K875297

Substantially Equivalent

Med-Text Intl.

FDA 510(k) clearance K875297 for JAMES TENDOS (SYRINGE HOLDER), Substantially Equivalent on 1988-04-19. Applicant: Med-Text Intl..

Clearance details

Applicant: Med-Text Intl.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1987-12-30
Decision date: 1988-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: S-24222 Horby, SE

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.