9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SI-450/ILUS (INTRALUMINAL ULTRASOUND)
FDA 510(k)
FDA Class 2
·Radiology
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
ALAMO C
FDA 510(k)
FDA Class 2
·Orthopedic
TELESCOPE, 10 MM, 0°, QUICK LOCK, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HET·October 31, 2023
TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code EWY·June 5, 2023
OLYMPUS CAPSULE ENDOSCOPE
FDA Adverse Event
Other
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KOG·June 26, 2014
BARD SILICONE CHANNEL DRAIN
FDA Adverse Event
Injury
·C.R. BARD, INC.·Product code GBX·November 11, 2010
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·January 11, 2013
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015