10,000 results
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53ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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