10 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GONIOMETER AND BIOMEDICAL RECORDER SYSTEM
FDA 510(k)
FDA Class 1
·Orthopedic
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884003000·dentaform® Band, Tooth 46, Size 3
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884003180·dentaform® Band, Tooth 46, Size 3/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884003220·dentaform® Band, Tooth 46, Size 3/Roth 22
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
FDA 510(k)
FDA Class 2
·Cardiovascular
MOTILITY INDOLE ORNITHINE-MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITI·June 19, 2014
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·October 20, 2010
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 21, 2012
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014