Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Bridger Biomed, Inc. · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

45 daysmedian FDA review time
224 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K003917MODIFICATION TO FLUOROTEX II SURGICAL MESHBridger Biomed, Inc.2001-01-26380
K003906MODIFICATION TO FLUROTEX SURGICAL MESHBridger Biomed, Inc.2001-01-26380
K002351FLUOROTEX II SURGICAL MESHBridger Biomed, Inc.2000-08-26240
K994032FLUORO-TEX CARDIOVASCULAR PATCHBridger Biomed, Inc.2000-07-072240
K984197FLUOROTEX SURGICAL MESHBridger Biomed, Inc.1999-01-07450
K980548DURA-PATCH MODEL DP-XXXBridger Biomed, Inc.1998-05-13900
K973178FLUORO-TEX SURGICAL MEMBRANEBridger Biomed, Inc.1997-11-24910

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda