28 results · 28ms · Sources: EU EUDAMED, US FDA

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PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49

FDA 510(k)
FDA Class 2 ·Cardiovascular

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0430200·Sagittal Bender, Double Ended Left

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0430210·Sagittal Bender, Double Ended Right

COBE HC 700 MIDI HEMOCONCENTRATOR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

SILCONE COATED I/A 45 HANDHELD INSTRUMENT

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·May 7, 2019

CP840442 DE LEIPZIG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·May 12, 2010

CP025369 DE LEIPZIG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·August 3, 2011

CP85315 IT MODENA

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·January 14, 2013

CP84050 FR LA REUNION

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·May 17, 2012

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

CP84042 DE LEIPZIG %

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DWE·April 20, 2011

D905 DIDECO EOS SINGLE HVR

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·September 25, 2013

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

SARNS CENTRIFUGAL PUMP

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·March 7, 2013

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 25, 2011