9 results
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26ms
·
Sources: EU EUDAMED, US FDA
PRO-JECT(TM) SAFETY NEEDLE HOLDER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994435484·SCREW 7892665 HA COATED NONCAN 6.5 X 65
Accelerate Pheno System, Accelerate PhenoTest BC Kit
FDA 510(k)
FDA Class 2
·Microbiology
PIXIE
FDA 510(k)
FDA Class 2
·Radiology
WEBSTER QUADROPOLAR - FIXED
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·June 26, 2012
ELLIPSE DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 24, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 2, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 28, 2010
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