29 results
·
71ms
·
Sources: EU EUDAMED, US FDA
Bio-CORE Cannula (Needle) Set
FDA Recall
Terminated
·Biologic Therapies, Inc·Product code FGY·January 23, 2015
Bio-MAC Cannula (Needle) Set
FDA Recall
Terminated
·Biologic Therapies, Inc·Product code FGY·January 23, 2015
Bio-PLASTY Cannula (Needle)
FDA Recall
Terminated
·Biologic Therapies, Inc·Product code FGY·January 23, 2015
Bio-CORE Cannula (Needle) Set
FDA Enforcement
Class II
·Terminated·Biologic Therapies, Inc·April 8, 2015
Bio-PLASTY Cannula (Needle)
FDA Enforcement
Class II
·Terminated·Biologic Therapies, Inc·April 8, 2015
Bio-MAC Cannula (Needle) Set
FDA Enforcement
Class II
·Terminated·Biologic Therapies, Inc·April 8, 2015
GENADYNE A4 NEGATIVE PRESSURE WOUND THERAPY UNIT
FDA Adverse Event
Malfunction
·GENADYNE BIOTECH, INC·Product code OMP·October 8, 2013
ORTHADAPT BIOIMPLANT
FDA Adverse Event
Injury
·PEGASUS BIOLOGICS, INC.·Product code FTM·November 2, 2009
OPTIGUIDE FIBER OPTIC DIFFUSER
FDA Adverse Event
Malfunction
·PINNACLE BIOLOGICS, INC.·Product code MVG·July 29, 2021
OPTIGUIDE FIBER OPTIC DIFFUSER, DCYL SERIES
FDA Adverse Event
Malfunction
·PINNACLE BIOLOGICS, INC.·Product code MVG·August 6, 2019
ADVIA 2120I WITH AUTOSAMPLER
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·December 14, 2012
EXPANDER
FDA Adverse Event
Injury
·Product code LCJ·October 16, 2012
ORTHADAPT BIOIMPLANT
FDA Adverse Event
Injury
·PEGASUS BIOLOGICS, INC.·Product code FTM·December 11, 2009
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·February 15, 2019
FOOTPRINT MEDICAL PICC 1.4FR
FDA Adverse Event
Injury
·FOOTPRINT MEDICAL, INC.·Product code LJS·July 8, 2016
INTROCAN® SAFETY
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code DQR·March 10, 2016
TANDEMLUNG OXYGENATOR
FDA Adverse Event
Injury
·CARDIACASSIST INC.·Product code DTZ·January 12, 2022
LIFESPARC SYSTEM
FDA Adverse Event
Injury
·LIVANOVA DEUTSCHLAND·Product code KFM·June 16, 2021
GYNECARE TVT-ABBREVO MINI LCM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·April 25, 2023
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·November 26, 2025