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ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101

FDA Enforcement
Class II ·Completed·Materialise N.V.·August 9, 2023

EP-4 CLINICAL STIMULATOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - COOPER RUN EXECUTIVE PARK·Product code JOQ·February 26, 2009

*

FDA Adverse Event
Malfunction ·MICROPACE PTY. LTD.·Product code JOQ·May 14, 2014

EP-WORKMATE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC. (AF-ST. PAUL)·Product code JOQ·April 4, 2014

EP-4 STIMULATOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL·Product code JOQ·March 18, 2010

BLOOM DTU-215A STIMULATOR SYSTEM

FDA Adverse Event
Injury ·FISCHER IMAGING CORP.·Product code JOQ·September 11, 1996

WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC.·Product code JOQ·November 2, 2017

CARDIAC STIMULATOR

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JOQ·June 9, 2021

EP-WORKMATE¿ EP-4¿ CARDIAC STIMULATOR, 4 CHANNEL

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC.·Product code JOQ·December 6, 2017

CARDIAC STIMULATOR

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JOQ·May 26, 2022

EP-4 STINULATOR, 4 CAHNNEL

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, AF DIVISION·Product code JOQ·May 24, 2012

BLOOM

FDA Adverse Event
Malfunction ·FISCHER MEDICAL·Product code JOQ·June 1, 2012

EP-4 STIMULATOR, 2 CHANNEL

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, AF DIVISION·Product code JOQ·January 12, 2012

MICRO-PACE

FDA Adverse Event
Death ·PACE MEDICAL, INC.·Product code JOQ·March 28, 2012

WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC.·Product code JOQ·October 27, 2017

WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC.·Product code JOQ·December 14, 2017

TELECTRONIC

FDA Adverse Event
Injury ·TELECTRONICS PACING SYSTEMS·Product code JOQ·January 14, 1994

CARDIAC PULSE GENERATOR

FDA Adverse Event
Malfunction ·SIEMENS PACESETTER INC.·Product code JOQ·February 4, 1994

MINIX

FDA Adverse Event
MEDTRONIC·Product code JOQ·January 20, 1994

TELECTRONICS META 11

FDA Adverse Event
Injury ·TELECTRONICS PACING SYSTEMS·Product code JOQ·January 14, 1994