7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
APEX DISPOSABLE INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TRIO MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEMOCHRON SIGNATURE ELITE
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTICS·Product code JPA·May 25, 2016
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·February 4, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·December 23, 2010
SIGMA FEM ADAPTER 5 DEGREE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.1818910·Product code JWH·July 17, 2014