Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Agency For Medical Innovations GmbH · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K212659More-Cell-SystemAgency For Medical Innovations GmbH2021-11-10790
K182013EasyInstrumentsAgency For Medical Innovations GmbH2019-03-112270
K182664FiXcisionAgency For Medical Innovations GmbH2018-12-07730
K150718Wi-3 HAL-RAR SystemAgency For Medical Innovations GmbH2015-06-12850

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