8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AIA-PACK(R) PROG ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZOLL X SERIES
FDA 510(k)
FDA Class 3
·Cardiovascular
TCM COMBIM
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS·Product code LKD·September 4, 2015
T-SLING
FDA Adverse Event
Injury
·HERNIAMESH S.R.L.·Product code FTM·January 25, 2013
ADEL LABOR AND DELIVERY BED
FDA Adverse Event
Malfunction
·STRYKER CORP. MEDICAL DIV.·Product code HDD·December 2, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2014
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016