10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
GRAFT, COOLEY GUIDELINE, STERILE
FDA 510(k)
FDA Class 2
·Cardiovascular
Lumipulse G ROMA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HOMECHOICE PRO
FDA Adverse Event
Death
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 18, 2014
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·July 9, 2010
VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD WITH VARIABLE OFFSET
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBF·April 26, 2017
HYBRID GLENOID BASE 4 MM MEDIUM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·April 26, 2017
VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBF·April 26, 2017
PT HYBRID GLENOID POST REGENEREX POROUS TI CONSTRUCT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·April 26, 2017