13 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CK-NAC 2-VIAL REAGENT W/SUBSTRATE START
FDA 510(k)
FDA Class 2
·Clinical Chemistry
C-CAT Anaesthesia Catheter kit
FDA 510(k)
FDA Class 2
·Anesthesiology
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 6, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 7, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 6, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·April 27, 2018
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·April 16, 2018
DEXTRUS 4136
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·June 24, 2014
OT PING METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·November 4, 2010
ON-Q SILVERSOAKER CATHETER
FDA Adverse Event
Malfunction
·I-FLOW, LLC·Product code BSO·December 6, 2012
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 5, 2018
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012