FDA applicant
Waldemar Link GmbH & Co. KG
FDA records 43 decisions for Waldemar Link GmbH & Co. KG (Norderstedt, DE) from 1978 to 2026: 43 510(k) clearances. Most are in product codes LZO (Prosthesis, Hip, Semi-Constrained…) and KRO (Prosthesis, Knee, Femorotibial, Constrained…). Since 2016 its 510(k)s took a median of 155 days from receipt to decision, against 112 for FDA’s reviews in the same codes and years. Its devices cite 117 predicates, 39 of them its own earlier devices. 70 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Waldemar Link GmbH & Co. KG’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
14in 2026
Class I Class II/III not classified
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