510(k) Report

FDA applicant

Bard Medical Div.

Covington, GA3 decisions1997–19993 recalls

FDA records 3 decisions for Bard Medical Div. (Covington, GA) from 1997 to 1999: 3 510(k) clearances. Most are in product codes MJC (Catheter, Urological (Antimicrobial) And…) and ODC (Endoscope Channel Accessory). 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 Medical Div.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bard Medical Div. since 2007.

Recalls per year

2in 2026

2026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Bard”

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