22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QIZHOU ACUPUNCTURE NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
Natus
FDA UDI
XLTEK·00382830016315·Natus Quantum Base Unit
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033542729·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033542668·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033542705·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033542712·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033542675·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033542682·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033542699·
R-SI-LINE METAL-BITE
FDA 510(k)
FDA Class 2
·Dental
ELEC-MATE E
FDA 510(k)
FDA Class 1
·Dental
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·November 10, 2025
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·November 10, 2025
FLOTATION CUSHION
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code KIC·March 20, 2013
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·March 10, 2011
LASIK
FDA Adverse Event
Injury
·Product code LZS·March 13, 2008
AXIOM ARISTOS VX PLUS
FDA Adverse Event
Injury
·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·May 2, 2013
Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·January 13, 2016
Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.
FDA Recall
Terminated
·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·Product code GWQ·November 11, 2015