8 results
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13ms
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Sources: EU EUDAMED, US FDA
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
FDA Enforcement
Class II
·Terminated·Medacta Usa·November 25, 2015
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·June 15, 2022
GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.
FDA Enforcement
Class II
·Terminated·Medacta Usa·November 19, 2014
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·July 12, 2017
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
FDA Enforcement
Class II
·Terminated·Medacta Usa Inc·December 27, 2017
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
FDA Enforcement
Class II
·Terminated·Lab Vision Corporation·January 22, 2014
Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.
FDA Enforcement
Class II
·Terminated·Water Pik, Inc.·August 15, 2018
Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality.
FDA Enforcement
Class II
·Terminated·Ventana Medical Systems Inc·September 4, 2013