10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
PACHYCAM
FDA 510(k)
FDA Class 2
·Ophthalmic
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
35/CD CINECONVERTER
FDA 510(k)
FDA Class 2
·Radiology
SYRINGE 10ML SALINE FILL CHINA SP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code NGT·July 15, 2025
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·June 16, 2010
ENDOTAK ENDURANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 6, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013
INSIGNIA PLUS
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 10, 2025
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018