22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOSAIQ® OIS (Oncology Information System)
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code GEX·January 2, 2024
REMOTE PRESENCE SYSTEM, MODEL RP-VITA
FDA 510(k)
FDA Class 2
·Cardiovascular
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
FDA 510(k)
FDA Class 2
·Radiology
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 11, 2008
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 11, 2008
UNK
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 11, 2008
TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·November 6, 2018
TENSION FREE VAGINAL TAPE - SECUR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·November 6, 2018
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 11, 2008
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 11, 2008
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 11, 2008
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 16, 2011
COULTER® LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 12, 2013
BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company, BD Biosciences·November 9, 2022
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code MFK·August 22, 2019
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code MFK·August 22, 2019
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code MFK·August 22, 2019
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·December 6, 2017