29 results · 71ms · Sources: EU EUDAMED, US FDA

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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