27 results · 21ms · Sources: EU EUDAMED, US FDA

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R&D RET-LINE KIT

FDA 510(k)
FDA Class 2 ·Hematology

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033540466·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033540442·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033540435·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033540428·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033540473·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033540459·

EBI VUECATH SPINAL ENDOSCOPIC SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145

FDA 510(k)
FDA Unclassified ·Unknown

ULTRACISION SURG, DEV, BLADES 5MM OPEN

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code LFL·June 16, 2006

ST. JOSEPH HSP BALTIMORE MD1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010

DAILY ACTIVITY ASSIST DEVICES

FDA Adverse Event
POPULAR PLASTICS·Product code IKX·March 20, 2013

TENDRIL ST

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

PULSE GEN MODEL 102

FDA Adverse Event
Death ·CYBERONICS, INC.·Product code LYJ·March 14, 2008

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020

CHILDRENS MERCY KS CITY MO1

FDA Adverse Event
Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

SMART, PERFUSION PACKS, CONNECTORS, TUBING

FDA Adverse Event
Malfunction ·LIVANOVA USA·Product code DWE·August 1, 2023

UNK_ULTRACISION HARMONIC FOCUS

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 1, 2025

CSC14 CARDIOLOGIA HEAT EXCHANGER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·April 20, 2023

CSC14 BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTR·March 10, 2016