182 results · 21ms · Sources: EU EUDAMED, US FDA

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K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C

FDA 510(k)
FDA Class 2 ·Hematology

THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST

FDA 510(k)
FDA Class 2 ·Microbiology

VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

RELION PRIME BLOOD GLUCOSE SYSTEM

FDA Adverse Event
Malfunction ·ARKRAY, INC.·Product code NBW·April 2, 2013

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·March 22, 2011

CELL-DYN WBC REAGENT A

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·April 15, 2008

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

FDA Enforcement
Class II ·Terminated·Medical Components, Inc dba MedComp·June 15, 2016

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

FDA Recall
Terminated ·Medical Components, Inc dba MedComp·Product code DYB·May 5, 2016

BD PHOENIX¿ PMIC/ID-107

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 4, 2025

BD PHOENIX¿ PMIC/ID-107

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·July 23, 2025

BD PHOENIX¿ PMIC/ID-107

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·September 4, 2025