Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 4 companies' records, each linked to the record.
As of Nov 15, 2026, FDA's public records list Merz Group and its 4 subsidiaries with 23 510(k) clearances, 6 device recalls, 5 drug applications and 1 OPDP letter. The most recent is a 510(k) clearance dated May 21, 2026: Ulthera® System.
Group recordsLabelled by a language model (which subsidiaries belong to the group) from the firm's FDA names. It is not an FDA field.: 35, 5 entities
510(k) clearances: 23
Device recalls: 6
Drug applications: 5
OPDP letters: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Merz Group and its 4 subsidiaries
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
22017Records2
220182018Records2vs 2017+0
12019Records1vs 2018−1
120202020Records1vs 2019+0
02021Records0vs 2020−1
020222022Records0vs 2021+0
02023Records0vs 2022+0
120242024Records1vs 2023+1
22025Records2vs 2024+1
120262026 to dateRecords1
Latest Records
Newest first across sources; each opens the record
Cellfina Prep Pack, Part No. CP1Class II · It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) de
Device recalls
Subsidiaries and Divisions
4 firms in the Merz Group group, most records first
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata.How this page is built
