38 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
FDA Recall
Terminated
·Medacta Usa Inc·Product code LXH·April 13, 2022
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
FDA Enforcement
Class II
·Terminated·Medacta Usa·November 25, 2015
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
FDA Recall
Terminated
·Medacta Usa·Product code KRO·April 17, 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
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 Recall
Terminated
·Medacta Usa·Product code HSB·September 22, 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
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
FDA Recall
Terminated
·Medacta Usa Inc·Product code KRO·May 19, 2017
Benchmark, Slide Staining System, Catalog Number: N750-BMK-FS, Ventana Medical Systems Inc, Tucson, AZ
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code KPA·September 29, 2006
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
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 Recall
Terminated
·Medacta Usa Inc·Product code JWH·October 24, 2017
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
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 Recall
Terminated
·Ventana Medical Systems Inc·Product code KPA·June 12, 2008
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 Recall
Terminated
·Lab Vision Corporation·Product code MVU·December 6, 2013
Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use.
FDA Recall
Terminated
·International Technidyne Corp·Product code FMK·January 23, 2006
Virotek SAFEL*E*T 1.0 mm Safety Lancets, 1.0 mm depth, stock code 5000052, packaged in single unit blister packs, 150 or 200 per box, 6 boxes per carton; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089
FDA Recall
Terminated
·Efoora, Inc. dba Virotek, L.L.C.·Product code FMK·May 5, 2005
StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock device provides stabilization for compatible medical tubes and catheters.
FDA Recall
Terminated
·Bard Access Systems·Product code KMK·June 10, 2013
StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock PICC Plus and StatLock CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively.
FDA Recall
Terminated
·Bard Access Systems·Product code KMK·December 9, 2016
Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models 3144844001 (10 lancets) and 3583031002 (17 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code FMK·May 13, 2009