29 results
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20ms
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Sources: EU EUDAMED, US FDA
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
U04
FDA 510(k)
FDA Class 2
·Radiology
CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
FDA 510(k)
FDA Class 2
·General Hospital
9611993-2026-060942
FDA Adverse Event
Injury
·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·March 19, 2026
GII ARTICULAR INSERTER/EXTRACT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·October 24, 2023
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 26, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·March 25, 2011
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 4, 2014
DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
FDA Recall
Terminated
·Medrad Inc·Product code MWI·April 15, 2013
MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media.
FDA Recall
Terminated
·Medrad Inc·Product code DXT·May 17, 2010
Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets
FDA Recall
Terminated
·Bayer Medical Care, Inc.·Product code FPA·September 7, 2018
Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomagraphy.
FDA Recall
Terminated
·Medrad Inc·Product code DXT·October 24, 2011
Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
FDA Recall
Terminated
·Medrad Inc·Product code FPA·April 18, 2012
Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
FDA Recall
Terminated
·Medrad Inc·Product code FPA·April 18, 2012
Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
FDA Recall
Terminated
·Medrad Inc·Product code FPA·April 18, 2012
Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
FDA Recall
Terminated
·Medrad Inc·Product code FPA·April 18, 2012
Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
FDA Recall
Terminated
·Medrad Inc·Product code FPA·April 18, 2012
Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
FDA Recall
Terminated
·Medrad Inc·Product code FRN·April 18, 2012
Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
FDA Recall
Terminated
·Medrad Inc·Product code FPA·April 18, 2012