Brady Medical Products Co.: FDA filings under this applicant name

FDA lists 5 510(k) clearances under the applicant name “Brady Medical Products Co.” (first 1992, latest 1995), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 77 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

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Top product codes

Product codeDeviceSubmissions510(k) clearances
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic44
KMFBandage, Liquid11

Review panels

Most recent Brady Medical Products Co. 510(k) clearances

510(k)DeviceProduct codeDecision dateReview days
K945832BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGSNAE1995-03-0192
K941019BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSINGNAE1994-05-0462
K936052BRADY MEDICAL PRODUCTS HYSORB(TM) WOUND DRESSINGKMF1994-03-0777
K935848BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSINGNAE1994-02-1569
K922666TRANSORB(TM) ULCER & WOUND DRESSINGNAE1992-11-23179

Recalls

openFDA lists no recalls under a recalling firm named Brady Medical Products Co..

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Frequently asked questions

How many FDA 510(k) clearances are listed under Brady Medical Products Co.?

FDA lists 5 510(k) clearances under the applicant name “Brady Medical Products Co.” (first 1992, latest 1995), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Brady Medical Products Co.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Brady Medical Products Co. is 77 days.

Which FDA product codes appear under Brady Medical Products Co.?

The most frequent FDA product codes under this applicant name are NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic, 4); KMF (Bandage, Liquid, 1).

Next steps

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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