20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
A1c iGear System
FDA 510(k)
FDA Class 2
·Hematology
VERTEX RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 12, 2012
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWQ·October 30, 2009
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 3, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code KWP·July 29, 2011
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 17, 2020
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 13, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·October 11, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 10, 2019
OSSEOTITE® CERTAIN® IMPLANT 5 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·November 11, 2014
RIATA PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011
CRE? WIREGUIDED
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KOG·July 23, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
COBAS 6000 C (501) MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·October 10, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 30, 2021
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 7, 2020
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012