22 results · 23ms · Sources: EU EUDAMED, 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