9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CEPHALOSTAT
FDA 510(k)
FDA Class 2
·Dental
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471159433·SAGITTAL BLADE - DE SOUTTER STANDARD 9 x 40 x 0...
HL888SF
FDA 510(k)
FDA Class 2
·Cardiovascular
Titan 3W
FDA 510(k)
FDA Class 2
·Physical Medicine
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWP·June 10, 2014
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 6, 2012
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·August 9, 2016
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014