17 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
STRYKER CORPORATION·07613327056488·Insert, Dorsey Grasper
TRAATEK COTTONOID PATTIES
FDA 510(k)
FDA Class 2
·Neurology
LA JOIE
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
VERTE-STACK K030736, K041197
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019
NANOKNIFE SYSTEM
FDA Adverse Event
Injury
·ANGIODYNAMICS·Product code OAB·June 9, 2015
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·May 5, 2025
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 9, 2013
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·May 6, 2011
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 23, 2008
BD SEDITAINER¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 25, 2018
PROWLER SELECT
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRA·May 5, 2025
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·October 27, 2025
BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16"
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 1, 2023
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·August 12, 2025
PROWLER SELECT
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code QJP·August 12, 2025
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014