510(k) Report

FDA applicant

Bard Gynecology and Radiology

Covington, GA1 decision1994–19943 recalls

FDA records 1 decision for Bard Gynecology and Radiology (Covington, GA) in 1994: 1 510(k) clearance. All are in product code FCG (Biopsy Needle). 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Bard Gynecology and Radiology’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bard Gynecology and Radiology since 2007.

Recalls per year

2in 2016

2016: 2
2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bard Gynecology and Radiology by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bard Gynecology and Radiology’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Bard”

FDA records each applicant name separately; these may or may not be the same firm.