10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ESTILUX POSTERIOR XR
FDA 510(k)
FDA Class 2
·Dental
Bioplate®
FDA UDI
Bioplate, Inc.·M3848135680·BioMesh® Bender
Bioplate®
FDA UDI
Bioplate, Inc.·M384813568CP0·BioMesh® Bender
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
MTA-FILLAPEX
FDA 510(k)
FDA Class 2
·Dental
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·March 26, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 31, 2012
SECURA DR
FDA Adverse Event
Death
·MEDTRONIC S.A.·Product code LWS·August 25, 2010
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813568.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813568. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DWF·October 16, 2008