15 results
·
38ms
·
Sources: EU EUDAMED, US FDA
ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
FDA 510(k)
FDA Class 2
·Hematology
CELL-DYN 3700 SL ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·February 22, 2019
PICO Single Use Negative Pressure Wound Therapy System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DR VISION NEO, DR VISION DOU
FDA 510(k)
FDA Class 2
·Radiology
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 25, 2014
WAVELIGHT FS200 FEMTOSECOND LASER
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code GEX·February 21, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·February 7, 2011
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Injury
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 18, 2026
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 27, 2026
Upper Torso Tray, part number PSS1554(B
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Injury
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 18, 2026
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·March 20, 2024
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·October 26, 2023
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·November 20, 2023