Lombard Medical Limited: FDA filings under this applicant name

FDA lists 0 510(k) clearances under the applicant name “Lombard Medical Limited”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Top product codes

Review panels

• Cardiovascular (1)

PMA and De Novo decisions

Recalls

openFDA lists no recalls under a recalling firm named Lombard Medical Limited.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Frequently asked questions

How many FDA 510(k) clearances are listed under Lombard Medical Limited?

FDA lists 0 510(k) clearances under the applicant name “Lombard Medical Limited”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

Which FDA product codes appear under Lombard Medical Limited?

The most frequent FDA product codes under this applicant name are MIH (System, Endovascular Graft, Aortic Aneurysm Treatment, 1).

Next steps

• See all 0 Lombard Medical Limited clearances with predicates and recalls
• Run predicate analysis for product code MIH, Lombard Medical Limited's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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