15 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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
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
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
FDA Enforcement
Class II
·Ongoing·Klinika Mdical Gmb·May 21, 2025
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
FDA Enforcement
Class II
·Ongoing·Klinika Mdical Gmb·May 21, 2025
ClubMax Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Atom Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Maxim Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Spectrum Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Burstberry Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019
Logolas Laser Projection Series
FDA Enforcement
Class II
·Ongoing·Gk Photonics Inc·August 14, 2019