4 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019
02.122.600S, 100mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code KTW·October 27, 2010
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·March 18, 2020
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013