15 results · 31ms · Sources: EU EUDAMED, US FDA

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WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE

FDA 510(k)
FDA Class 1 ·General Hospital

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·May 21, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

MESH, SURGICAL, POLYMERIC

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 14, 2011

SHORELINE ACS, WAVEFORM C

FDA Adverse Event
Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

SHORELINE ACS, WAVEFORM C

FDA Adverse Event
Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

SHORELINE ACS, WAVEFORM C

FDA Adverse Event
Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

BD INSYTE AUTOGUARD

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 20, 2025

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023

Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·October 18, 2023

TDx/TDxFLx Opiates Reagent, Product list number: 9673-60

FDA Recall
Terminated ·Abbott Health Products, Inc.·Product code DJG·May 28, 2004