8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
VAS DILATOR
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM
FDA 510(k)
FDA Class 2
·Dental
PEGASUS NASAL CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
AUTOCAT2 WAVE
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·January 16, 2013
VIRTUOSO II VR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2014
Cardiovascular Diseases Health Risk Questionnaire
Basic UDI-DI
EU MDD
·
Eu Md Class 1
·Oiva Health Oy·1 device
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