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

NOUVAG AG · Predicate Candidate Screening

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

95 daysmedian FDA review time
429 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K080365MORCE POWER PLUS AND VARIOCARVE MORCELLATORNOUVAG AG2009-06-295040
K081191TCM ENDO 20NOUVAG AG2008-08-071010
K071588DISPENSER DP 20NOUVAG AG2007-11-261680
K042822TCM ENDO V, MODEL 1534NOUVAG AG2004-12-22710
K042943NOUVAG AG - VACUSON 40 AND VACUSON 60NOUVAG AG2004-12-17530
K042434MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55NOUVAG AG2004-11-03560
K022505CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 505NOUVAG AG2003-10-014290
K013185TCM ENDO IIINOUVAG AG2001-11-28650
K000710MD 10, SEM, SM 12, CBMNOUVAG AG2000-05-11700
K981679TCM 3000 AND TCM ENDONOUVAG AG1999-02-092720
K954722MICRO-DISPENSER 7000 & MICRODISPENSER 8000NOUVAG AG1996-01-16950

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