7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
EXTRACT BROTH
FDA 510(k)
FDA Class 1
·Microbiology
Steerant Super Stiff Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
ELECTRIC HANDPIECE SYSTEM
FDA 510(k)
FDA Class 1
·Dental
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2012
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 27, 2014
SUPER SHEATH INTRODUCER SHEATH
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DRE·September 13, 2010
The Quidel Triage BNP Calibrators
FDA Enforcement
Class II
·Terminated·Medline Industries Inc·November 4, 2020