FDA applicant
Peter Lazic GmbH
FDA records 2 decisions for Peter Lazic GmbH (Mühlheim An Der Donau, DE) from 2008 to 2019: 2 510(k) clearances. All are in product code HCH (Clip, Aneurysm). 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Peter Lazic GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2008high 1 (2008) · low 0 (2009)2026
2026 so far, outlined.
Recalls per year
5in 2023
2008high 5 (2023) · low 0 (2008)2026
Class I Class II/III not classified
Planning a device like Peter Lazic GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Peter”
FDA records each applicant name separately; these may or may not be the same firm.