12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
10F Sheath and Dilator Set
FDA 510(k)
FDA Class 2
·Cardiovascular
LEXATITE QUICK ACRYLIC
FDA 510(k)
FDA Class 2
·Dental
SHERPA PAK CARDIAC TRANSPORT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·August 18, 2010
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 22, 2026
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·December 14, 2015
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·December 14, 2015
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·September 2, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·June 2, 2025
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·September 11, 2025