12 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PREMIER DECANNULATION STOPPER
FDA 510(k)
FDA Class 2
·Anesthesiology
CENTAUR
FDA UDI
Stryker Corporation·07613327262124·PLATE HOLDER
Snowden-Pencer
FDA UDI
STERIS CORPORATION·10885403152603·Snowden-Pencer DIAMOND-TIP RUBIN TYPE OSTEOTOME...
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884015180·dentaform® Band, Tooth 46, Size 15/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884015000·dentaform® Band, Tooth 46, Size 15
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884015220·dentaform® Band, Tooth 46, Size 15/Roth 22
SELENITE BROTH
FDA 510(k)
FDA Class 1
·Microbiology
CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE
FDA 510(k)
FDA Class 1
·Neurology
PATIENT LIFT
FDA Adverse Event
Death
·MEDLINE INDUSTRIES, INC.·Product code FSA·June 13, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·October 14, 2010
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIQ·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