65 results
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7ms
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Sources: EU EUDAMED, US FDA
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Enforcement
Class II
·Ongoing·Heraeus Medical GmbH (Dental Division)·January 21, 2026
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·April 1, 2026
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·April 1, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·December 17, 2025
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 20, 2025
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 20, 2025
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·September 17, 2025