16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STOCKERTIR PURGE CONTROL (APC) SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
FDA 510(k)
FDA Class 2
·Microbiology
VERTE-STACK SPINAL SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·January 21, 2010
VERTE-STACK SPINAL SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code ODP·November 20, 2009
LIFESHIELD LATEX FREE SYMBIQ PUMP SET
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 16, 2012
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·February 23, 2011
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·July 1, 2010
UNK
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·January 7, 2011
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 8, 2013
NEW LIGASURE 5MM
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·March 10, 2011
VENTAK PRIZM HE DR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
MAXIFLO ULTRATHIN WITH UNITY CONTRUCTION
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 27, 2012
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024