88 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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AMEDTEC Medizintechnik Aue GmbH
Manufacturer
🇩🇪 Germany
ARTICARES PTE LTD
Importer
🇩🇪 Germany·1 Manufacturer
AMEDTEC Medizintechnik Aue GmbH
Importer
🇩🇪 Germany
AMEDTEC Medizintechnik Aue GmbH
System producer
🇩🇪 Germany
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
Roceso Medical GmbH
Importer
🇩🇪 Germany·1 Manufacturer
Venner Medical (Deutschland) GmbH
Importer
🇩🇪 Germany·1 Manufacturer
FUJIFILM Wako Chemicals Europe GmbH
Importer
🇩🇪 Germany·3 Manufacturers
Leica Microsystems CMS GmbH
Importer
🇩🇪 Germany·3 Manufacturers
Promedics Medizinische Systeme GmbH
Importer
🇩🇪 Germany·12 Manufacturers
SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
FDA Enforcement
Class II
·Ongoing·Bebig Isotopentechnik Gmbh·December 20, 2023
Cirq Arm System 2.0
FDA Enforcement
Class II
·Ongoing·Brainlab AG·April 5, 2023
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
FDA Enforcement
Class II
·Ongoing·KOB GmbH·March 18, 2026
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
FDA Enforcement
Class II
·Terminated·DRG Instruments GmbH·August 22, 2018
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 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: 15-0027/11;
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 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: 15-8521/15;
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026