30 results
·
35ms
·
Sources: EU EUDAMED, US FDA
IHEALTH
FDA Adverse Event
Malfunction
·ANDON MEDICAL CO.,LTD·Product code QKP·October 24, 2022
IHEALTH
FDA Adverse Event
Malfunction
·ANDON MEDICAL CO.,LTD·Product code QKP·October 24, 2022
IHEALTH COVID-19 ANTIGEN RAPID TEST
FDA Adverse Event
Malfunction
·IHEALTH LABS, INC.·Product code QKP·September 21, 2022
i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code MMI·February 1, 2012
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR
FDA Recall
Open, Classified
·Invacare Corporation·Product code ITJ·June 15, 2023
MedEnvoy Global BV
Authorized representative
🇳🇱 Netherlands·143 Manufacturers·2306 Devices
CEpartner4U
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🇳🇱 Netherlands·160 Manufacturers·5787 Devices
Emergo Europe B.V.
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🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Wellkang Ltd
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259 Manufacturers·3500 Devices
MedEnvoy Global BV
Importer
🇳🇱 Netherlands·234 Manufacturers