Waldemar Link GmbH & Co. KG is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Waldemar Link GmbH & Co. KG - FDA 510(k) Cleared Devices
Recent clearances: Allure Hip Stem and Intramedullary Plugs, MobileLink Acetabular Cup System - inhouse coatings, MobileLink Acetabular Cup System - Line Extension (Multiple)
42
Total
42
Cleared
0
Denied
Waldemar Link GmbH & Co. KG has 42 FDA 510(k) cleared orthopedic devices. Based in Mchenry, US.
Latest FDA clearance: Nov 2025. Active since 1978.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by LinkBio Corp. and Linkbio Corp. (U.S. Distributor/Initial Importer).
FDA 510(k) Regulatory Record - Waldemar Link GmbH & Co. KG
42 devices
Cleared
Nov 05, 2025
Allure Hip Stem and Intramedullary Plugs
Orthopedic
268d
Cleared
May 16, 2025
MobileLink Acetabular Cup System - inhouse coatings
Orthopedic
147d
Cleared
Nov 08, 2024
MobileLink Acetabular Cup System - Line Extension (Multiple)
Orthopedic
155d
Cleared
Nov 16, 2023
LINK Embrace Shoulder System - Reverse Configuration
Orthopedic
182d
Cleared
Apr 14, 2023
LINK MobileLink Acetabular Cup System
Orthopedic
275d
Cleared
Mar 21, 2023
LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface
Orthopedic
28d
Cleared
Sep 13, 2022
SP-CL Hip Stem and LCU Hip System
Orthopedic
285d
Cleared
Jul 20, 2022
Vario-Cup System
Orthopedic
29d
Cleared
Jun 03, 2022
BiMobile Instruments (for BiMobile Dual Mobility System)
Orthopedic
378d
Cleared
May 03, 2022
LINK Endo-Model EVO Knee System
Orthopedic
60d
Cleared
Apr 11, 2022
MP Reconstruction System
Orthopedic
140d
Cleared
Nov 18, 2021
LINK® Embrace Shoulder System - Reverse Configuration
Orthopedic
59d
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