15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
LEva Pelvic Digital Health System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 26, 2018
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORP·Product code LZG·February 20, 2009
INSYTE AUTOG BC PNK 20GA X 1.0IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·November 30, 2023
INSYTE AUTOG BC PNK 20GA X 1.0IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·November 30, 2023
BD INSYTE AUTOG BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 20, 2023
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 29, 2023
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 29, 2023
MERGE CARDIO
FDA Adverse Event
Malfunction
·MERGE HEALTHCARE SOLUTIONS INC.·Product code LLZ·October 20, 2023
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC CRMD·Product code NIK·January 11, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code KWA·June 27, 2013
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018