15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAM STRUCTSURE PRECISION MILLED BARS
FDA 510(k)
FDA Class 2
·Dental
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014607931·STERIS-AMSCO 3080, 3085 4.25" DELUXE GEL
FAST1 INTRAOSSEOUS INFUSION SYSTEM
FDA Adverse Event
Other
·PYNG MEDICAL CORP.·Product code FMI·October 9, 2009
INTRASTENT DOUBLESTRUT XS STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANALYST PANELS + ANALYTICAL TEST ROTOR
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
RELION CONFIRM BLOOD GLUCOSE SYSTEM
FDA Adverse Event
Malfunction
·ARKRAY, INC.·Product code NBW·April 26, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 6, 2011
NONE
FDA Adverse Event
Other
·NOBEL BIOCARE USA·Product code DZE·July 9, 2008
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