21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIO-CONSOLE, MODEL 560
FDA 510(k)
FDA Class 2
·Cardiovascular
Ipsoclip
FDA UDI
Cendres+Métaux SA·07640173093565·Ipsoclip SE/RE, Screwdriver
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699432·Paltop Equator Retentive Cap for Lab, Black
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BRAHMS DIAGNOSTICA LUMITEST ANTI-TG
FDA 510(k)
FDA Class 2
·Immunology
SERVICE, CCU, HIGH DEF, 560P, 2NDGEN
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code GCJ·May 9, 2016
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 12, 2018
TRIAGE CARDIAC HS PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 22, 2019
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code MMI·May 18, 2018
TRIAGE CARDIAC PANEL KIT
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code JHX·April 18, 2018
TRIAGE CARDIAC HS PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 21, 2019
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code MMI·October 5, 2017
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code CBK·April 16, 2013
ZNN CMN NAIL 10MMX21.5CM 125R
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDS·April 15, 2011
GE OEC 2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code MMI·November 1, 2018
TRIAGE CARDIAC TRIPLE MARKER PANEL
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code MMI·May 17, 2017
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022