STRATASYS FDM MEDMODELER SYSTEM— 510(k) K971290

Substantially Equivalent

Paladin Medical, Inc.

FDA 510(k) clearance K971290 for STRATASYS FDM MEDMODELER SYSTEM, Substantially Equivalent on 1997-06-20. Applicant: Paladin Medical, Inc..

Clearance details

Applicant: Paladin Medical, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1997-04-07
Decision date: 1997-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.