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

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VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696

FDA 510(k)
FDA Class 2 ·Immunology

Alteon

FDA UDI
Exactech, Inc.·10885862549372·

HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS

FDA 510(k)
FDA Class 2 ·Cardiovascular

AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A

FDA 510(k)
FDA Class 2 ·Cardiovascular

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·December 17, 2018

ZILVER BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·March 5, 2020

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·September 26, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 24, 2018

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 24, 2025

4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code JDP·March 26, 2013

NATRELLE SILICONE-FILLED FULL PROFILE STYLE 45 BREAST IMPLAN

FDA Adverse Event
Malfunction ·ALLERGEN·Product code FTR·March 7, 2011

POLYFLUX R CAPILLARY DIALYZER

FDA Adverse Event
Other ·GAMBRO DIAYLZSATOREN GMBH·Product code KDI·March 3, 2008

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·October 11, 2017

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·August 11, 2025

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·August 2, 2018

ZILVER 635 BILIARY SELF EXPANDING METAL STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2020