8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
MONITOR, OXYGEN, MODEL 78216C
FDA 510(k)
FDA Class 2
·Anesthesiology
Young Specialties
FDA UDI
Young Innovations, Inc.·00843471188309·.022 U/R STD. WELD SIZE #7
Obturys
FDA 510(k)
FDA Class 2
·Dental
MULTI-ANALYTE CHEMISTRY CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·March 12, 2014
THOR STANDARD SCREW 6.0X31MM
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code KWP·October 1, 2012
NANOKNIFE
FDA Adverse Event
Injury
·ANGIODYNAMICS·Product code GEI·July 21, 2010
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.
FDA Enforcement
Class II
·Terminated·Steris Corporation·August 5, 2020