39 results
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23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021917·
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
UNKNOWN
FDA Adverse Event
Malfunction
·COOK, INC.·Product code DTK·August 21, 2014
UNK
FDA Adverse Event
Injury
·COOK, INC.·Product code DTK·August 20, 2014
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·August 20, 2014
LCP WRIST FUSION STRAIGHT PLATE
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·April 23, 2013
VICTORY XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·September 9, 2014
VIRTUOSO DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code LWS·April 28, 2011
GUNTHER TULIP VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·April 3, 2026
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·September 12, 2017
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·November 11, 2021
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·December 5, 2017
GUNTHER TULIP VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·November 4, 2025
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·June 4, 2019
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·May 21, 2019
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·March 3, 2017
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·February 22, 2018
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·September 22, 2017