16 results
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24ms
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Sources: EU EUDAMED, US FDA
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
FDA 510(k)
FDA Class 1
·Radiology
SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295251279·SIGMA CURVED PLUS INSERT TRIAL SIZE 6 8mm
F.A.S.T. 1
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·May 30, 2006
U2 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
FARRIOR OVAL SPECULUM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FASTI INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·February 21, 2013
PULSE GEN MODEL 104
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·January 25, 2011
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 31, 2014
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.
FDA Enforcement
Class II
·Terminated·Cook Inc.·July 1, 2015