18 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MORCE POWER PLUS AND VARIOCARVE MORCELLATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Mapleson Anesthesia Breathing Circuit
FDA UDI
MERCURY ENTERPRISES, INC.·10641043803653·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450294963·
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·October 9, 2009
ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
ACCU-CHEK ADVANTAGE METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·July 20, 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·October 9, 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·October 26, 2010
EGIA 60 ARTICULATING MED/THICK SULU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL·Product code GAG·August 25, 2014
EON IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 22, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·July 22, 2008
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code ESW·November 12, 2014
PREMICATH
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·October 9, 2020
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·July 20, 2009
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014