BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007— 510(k) K033814

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K033814 for BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007, Substantially Equivalent on 2004-03-01. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2003-12-09
Decision date: 2004-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranston, RI, US

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Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.