17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Radiance V5
FDA 510(k)
FDA Class 2
·Radiology
BD NEXIVA CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 2, 2020
BD NEXIVA DUAL PORT 20GA 1.00IN (1.1 MM X 25 MM)
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 18, 2019
TANDEMHEART FEMORAL VENOUS CANNULA SET
FDA 510(k)
FDA Class 2
·Cardiovascular
PRIZM KERATOME BLADE, MODEL MK8512M2
FDA 510(k)
FDA Class 1
·Ophthalmic
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 20, 2019
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 16, 2020
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 17, 2021
UNKNOWN LIGASURE INSTRUMENT
FDA Adverse Event
Malfunction
·COVIDIEN MFG DC BOULDER·Product code GEI·February 25, 2021
BD NEXIVA CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 2, 2021
FLOSEAL
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code LMF·March 20, 2024
ALARIS 8015
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FRN·August 22, 2011
SYNERGY
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·November 6, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
UNKNOWN GII ANCHOR
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code JDR·October 22, 2019
Allura Xper FD20 Biplane; Model Number: 722013;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024