14 results
·
33ms
·
Sources: EU EUDAMED, US FDA
HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PregSense
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LANCER L-INA ANTI-IGA
FDA 510(k)
FDA Class 2
·Immunology
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
FREESTYLE LITE
FDA Adverse Event
Malfunction
·Product code NBW·November 4, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 31, 2014
ACROBAT-I STABILIZER
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·December 26, 2012
BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JCF·June 5, 2018
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023
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