7 results
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26ms
·
Sources: EU EUDAMED, US FDA
CPI MODEL 2215
FDA 510(k)
FDA Class 2
·Cardiovascular
DR. SCHOLL'S COMPRESSION SOCKS
FDA 510(k)
FDA Class 2
·General Hospital
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
FDA 510(k)
FDA Class 2
·Radiology
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·December 13, 2010
NEURON DELIVERY CATHETER 070
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·January 22, 2013
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015