Atlas FDA

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

Nexmed, Inc. — Predicate Candidate Screening

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

99 daysmedian FDA review time
266 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K033580NEXFLEX TOTAL HIP SYSTEMNexmed, Inc.2004-08-052660
K991882NEXFLEX TOTAL KNEE SYSTEMNexmed, Inc.1999-12-081890
K955170NEXFLEX FEMORAL STEM, STANDARD DESIGNNexmed, Inc.1996-02-09880
K955171NEXLOCK FEMORAL STEMNexmed, Inc.1996-02-09880
K952629NEXFLEX TOTAL HIP SYSTEMNexmed, Inc.1995-09-08920
K951656NEXMED CANCELLOUS BONE SCREWSNexmed, Inc.1995-07-18990

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