13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HemosIL Factor XII Deficient Plasma
FDA 510(k)
FDA Class 2
·Hematology
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
ACCUSOM
FDA 510(k)
FDA Class 2
·Anesthesiology
RIATA/RIATA ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.·Product code LWS·April 1, 2019
RIATA/RIATA ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.·Product code LWS·April 1, 2019
ARTERIAL PRESSURE MONITORING TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code DQO·December 3, 2024
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 20, 2013
UNICEL® DXC 600I SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 27, 2011
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS INC.·Product code LYJ·September 26, 2008
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·October 8, 2019
POLYETHYLENE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQO·April 5, 2022
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012