128 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·December 28, 2016
CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018
19Ga x 1 Huber Needle Set. Product Code: MBS-1910.
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018
20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018
Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018
3-Way Standardbore Stopcock. Product Code: AMS-100.
FDA Enforcement
Class II
·Terminated·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·February 28, 2018
BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.
FDA Enforcement
Class II
·Terminated·Waldemar Link GmbH & Co. KG (Mfg Site)·January 23, 2019
BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.
FDA Enforcement
Class II
·Terminated·Waldemar Link GmbH & Co. KG (Mfg Site)·January 23, 2019
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
Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 20, 2022
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·September 6, 2023
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 5, 2023
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-121/00
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·October 4, 2023
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 5, 2023
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-23/00
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 16, 2023