420 results
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7ms
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Sources: EU EUDAMED, US FDA
L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Sterile
FDA Enforcement
Class II
·Ongoing·Peter Lazic Gmbh·March 20, 2024
L-Aneurysm Clip TITANIUM Paddle-Clip, permanent, 11 mm straight, Non-Sterile
FDA Enforcement
Class II
·Ongoing·Peter Lazic Gmbh·March 20, 2024
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 26, 2025
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 26, 2025
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 26, 2025
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
Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
FDA Enforcement
Class II
·Terminated·Maquet Cardiopulmonary Ag·June 20, 2018
Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
FDA Enforcement
Class II
·Terminated·Maquet Cardiopulmonary Ag·June 20, 2018
Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass
FDA Enforcement
Class II
·Terminated·Maquet Cardiopulmonary Ag·June 20, 2018
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·January 24, 2024
L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7) 880-325/13 (Sz. 5-6 - cemented sm), (8) 880-325/23 (Sz. 5-6 - cemented lg), (9) 880-327/13 (Sz. 7-8 - cemented sm), (10) 880-327/23 (Sz. 7-8 - cemented lg), (11) 880-329/13 (Sz. 9-10 - cemented sm), (12) 880-329/23 (Sz. 9-10 - cemented lg).
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·May 7, 2025
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·January 1, 2025
SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);
FDA Enforcement
Class II
·Terminated·CSL Behring GmbH·December 6, 2017
LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for the following conditions: Revision arthroplasty due to juxta-articular bone defects Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone Revision of loosened femoral prosthesis components with periprosthetic/subprosthetic fracture Deformed proximal femur due to fractures or osteotomies Correction of bone deficiencies, e.g. due to tumors Large post-revision and post-trauma segmental bone defects Oncological and revision surgery from tibial to hip area (in conjunction with Endo-Model¿ SL Rotational and Hinge Knee Prostheses) The device is intended for cemented and cementless use.
FDA Enforcement
Class II
·Terminated·Waldemar Link GmbH & Co. KG (Mfg Site)·January 23, 2019
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
FDA Enforcement
Class II
·Ongoing·BERLIN HEART GMBH·June 17, 2026
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
FDA Enforcement
Class II
·Ongoing·Mint Medical GmbH·May 13, 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
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
FDA Enforcement
Class II
·Ongoing·Brahms GmbH·April 15, 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