8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER
FDA 510(k)
FDA Class 2
·Cardiovascular
LP Low Profile
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746092213·DB BKT LP V-SLOT LR CUSP 022 T-7 A+7 R=0
AUDIOTONE MODEL A-98
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
CORDIS REFLEX STEERABLE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 30, 2013
BRIDGE ASSURANT BILIARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code FGE·December 13, 2010
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 15, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021