9 results
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20ms
·
Sources: EU EUDAMED, US FDA
VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471129443·K-WIRE - DOUBLE TROCAR WITH GUIDE 1.1mm DIA x 1...
DVNET MDV-PACS
FDA 510(k)
FDA Class 2
·Radiology
SORIN CONNECT DATA MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
FREESTYLE FREEDOM LITE
FDA Adverse Event
Injury
·Product code NBW·November 16, 2010
XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·January 28, 2013
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT·Product code DQO·December 17, 2010
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·July 14, 2014
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020