95 results
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12ms
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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
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
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
PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070
FDA Recall
Terminated
·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007
PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Lot # 185-1 Exp 13AUG2008. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070
FDA Recall
Terminated
·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007
PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070
FDA Recall
Terminated
·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007
Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
FDA Recall
Terminated
·Pml Microbiologicals Inc.·Product code JSO·August 17, 2007