21 results · 24ms · Sources: EU EUDAMED, 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