8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
TSK STERIJECT STERILE EPIDURAL NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209126408·
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
AUTOGROUPER 16C SYS AUTOMATED REAG
FDA 510(k)
FDA Class 2
·Microbiology
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-CALIF·Product code NJE·June 6, 2014
UNKNOWN MESH PRODUCT (EWHU)
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·December 3, 2012
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·September 3, 2010
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017