Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

43 results for "Waldemar Link GmbH & Co. KG"
1–24 of 43
Search insights Median review: 102d Cleared: 100% Top manufacturer: Waldemar Link GmbH & Co. KG Lead specialty: Orthopedic
Cleared Jul 06, 2026
MobileLink Acetabular Cup System – 40mm ID Inserts (various)
K261009 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 102d
Cleared Nov 05, 2025
Allure Hip Stem and Intramedullary Plugs
K250375 · MEH
Waldemar Link GmbH & Co. KG
Orthopedic · 268d
Cleared May 16, 2025
MobileLink Acetabular Cup System - inhouse coatings
K243927 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 147d
Cleared Nov 08, 2024
MobileLink Acetabular Cup System - Line Extension (Multiple)
K241636 · LPH
Waldemar Link GmbH & Co. KG
Orthopedic · 155d
Cleared Nov 16, 2023
LINK Embrace Shoulder System - Reverse Configuration
K231445 · PHX
Waldemar Link GmbH & Co. KG
Orthopedic · 182d
Cleared Apr 14, 2023
LINK MobileLink Acetabular Cup System
K222066 · LPH
Waldemar Link GmbH & Co. KG
Orthopedic · 275d
Cleared Mar 21, 2023
LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface
K230471 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 28d
Cleared Sep 13, 2022
SP-CL Hip Stem and LCU Hip System
K213770 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 285d
Cleared Jul 20, 2022
Vario-Cup System
K221794 · KWY
Waldemar Link GmbH & Co. KG
Orthopedic · 29d
Cleared Jun 03, 2022
BiMobile Instruments (for BiMobile Dual Mobility System)
K211567 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 378d
Cleared May 03, 2022
LINK Endo-Model EVO Knee System
K220628 · KRO
Waldemar Link GmbH & Co. KG
Orthopedic · 60d
Cleared Apr 11, 2022
MP Reconstruction System
K213675 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 140d
Cleared Nov 18, 2021
LINK® Embrace Shoulder System - Reverse Configuration
K212992 · PHX
Waldemar Link GmbH & Co. KG
Orthopedic · 59d
Cleared Sep 16, 2021
GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System...
K212742 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 17d
Cleared Jun 30, 2021
LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
K211768 · KRO
Waldemar Link GmbH & Co. KG
Orthopedic · 22d
Cleared Jun 21, 2021
LINK Embrace Shoulder System- Anatomical Configuration
K210899 · KWT
Waldemar Link GmbH & Co. KG
Orthopedic · 87d
Cleared May 28, 2021
LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and...
K200607 · LPH
Waldemar Link GmbH & Co. KG
Orthopedic · 445d
Cleared May 13, 2021
LinkSymphoKnee System
K202924 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 226d
Cleared Feb 05, 2021
LINK Embrace Shoulder System - Reverse Configuration
K200368 · PHX
Waldemar Link GmbH & Co. KG
Orthopedic · 357d
Cleared Jul 17, 2020
LINK TrabecuLink Femoral Cones
K201364 · MBH
Waldemar Link GmbH & Co. KG
Orthopedic · 56d
Cleared Mar 18, 2020
LINK TrabecuLink Tibial Cones
K200113 · MBH
Waldemar Link GmbH & Co. KG
Orthopedic · 61d
Cleared Dec 21, 2019
Acetabular Bone Screws (for MobileLink Acetabular Cup System)
K192559 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 95d
Cleared Aug 06, 2019
BiMobile Dual Mobility System - E-Dur Inserts
K190535 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 155d
Cleared Jul 18, 2019
SPAR-K Instruments (for use with Gemini SL Total Knee System)
K191755 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 17d