9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
LANCER SPECIMEN CONTAINER
FDA 510(k)
FDA Class 1
·Pathology
ERA® Implant Abutment Micro 0°, .5mm Cuff (X)
FDA UDI
STERNGOLD DENTAL LLC·00841549106033·Implant retained overdentures are an establishe...
INHANCETM Hybrid Anatomic Glenoid Implant
FDA 510(k)
FDA Class 2
·Orthopedic
ACCESS THYROGLOBULIN ANITBODY
FDA 510(k)
FDA Class 2
·Immunology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 2, 2015
Expressaire, Disposable Tourniquet Cuff 34", 1 line (18), sterile, Manufactured for Sammons Preston, A Patterson Medical Company, Cedarburg, WI.; Cuff type A70107010. Each cuff is marked ExpressAire by Sammons Preston and A70107010. The tourniquet cuff is placed on a patient's thigh during an operation procedure of the lower leg. The cuff is not operational until it is attached to an air pump supply that is owned by the care giving facility (hospital).
FDA Recall
Terminated
·Virtus, Inc.·Product code KCY·November 24, 2008
Expressaire, Disposable Tourniquet Cuff 34", 2 line (18), sterile, Manufactured for Sammons Preston, A Patterson Medical Company, Cedarburg, WI.; Cuff type A70107011. Each cuff is marked ExpressAire by Sammons Preston and A70107011. The tourniquet cuff is placed on a patient's thigh during an operation procedure of the lower leg. The cuff is not operational until it is attached to an air pump supply that is owned by the care giving facility (hospital).
FDA Recall
Terminated
·Virtus, Inc.·Product code KCY·November 24, 2008