9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II
FDA 510(k)
FDA Class 1
·Clinical Chemistry
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123854·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 100mm
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
DERMAGRIP-N/MULTIPLE/WRP ASIA PACIFIC SDN BHD POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
FDA 510(k)
FDA Class 1
·General Hospital
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 27, 2012
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·December 13, 2010
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 9, 2014
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021