16 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Control-IQ+ technology
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813035771·Reamers With Silicone Stops 31MM #8
Oticon
FDA UDI
Sbo Hearing A/S·05714464092239·OTICON JET 2 MINIRITE T C092
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·November 27, 2013
Codent Low Speed Dental Handpieces and Accessories
FDA 510(k)
FDA Class 1
·Dental
ECLIPSE NEUROLOGICAL WORKSTATION
FDA 510(k)
FDA Class 2
·Neurology
NIM-ECLIPSE® ELECTRODE
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC.·Product code GXZ·May 16, 2016
NIM-ECLIPSE® ELECTRODE
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code GXZ·May 6, 2016
NIM-ECLIPSE® CONTROLLER
FDA Adverse Event
Injury
·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code FZP·December 2, 2008
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·September 16, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 29, 2013
DIGITAL PREAMPLIFIER
FDA Adverse Event
Malfunction
·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026
CONTROLLER ECLC ECLIPSE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014
IPC® HANDPIECE - STYLUS TOUCH®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code HBE·December 11, 2019
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013