19 results · 20ms · Sources: EU EUDAMED, US FDA

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DIAZYME SODIUM ENZYMATIC ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

ANGELTOUCH VENTED IV ADMINISTRATION SET

FDA 510(k)
FDA Class 2 ·General Hospital

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·January 12, 2012

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWQ·October 30, 2009

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 3, 2019

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code KWP·July 29, 2011

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2018

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 17, 2020

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 13, 2019

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·October 11, 2019

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 10, 2019

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORP.·Product code DSQ·April 4, 2013

VITALITY 2

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

INSIGNIA ULTRA

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014

EVOLUT FX DCS

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 1, 2025

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 30, 2021

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 7, 2020