20 results · 26ms · Sources: EU EUDAMED, US FDA

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AUTOPULSE RESUSCITATION SYSTEM MODEL 1000

FDA 510(k)
FDA Class 2 ·Cardiovascular

AUTOPULSE RESUSCITATION SYSTEM MODEL 100

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013

AUTOPULSE LI-ION BATTERY

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013

CONGRUENT BONE PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

AMPHETAMINE/METHAMPHETAMINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CRE¿ WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·February 20, 2013

CRE¿ WIREGUIDED

FDA Adverse Event
Death ·BOSTON SCIENTIFIC - CORK·Product code KNQ·September 7, 2012

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 14, 2024

CRE? WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 18, 2013

CRE¿ WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·January 7, 2013

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·May 15, 2013

EON MINI

FDA Adverse Event
Injury ·ST JUDE MED - NEUROMODULATION·Product code GZB·September 17, 2014

ASR UNI FEMORAL IMPL SIZE 41

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011

CRE¿ WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·March 13, 2013

CRE¿ WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·August 10, 2012

CRE? WIREGUIDED

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 6, 2013

CRE¿ WIREGUIDED

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - CORK·Product code KNQ·December 5, 2012

CRE¿ WIREGUIDED

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - CORK·Product code KNQ·July 2, 2012

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

FDA Enforcement
Class II ·Ongoing·Abbott Medical·January 1, 2025