10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO: BPCARD, MODEL Z-7000-0700
FDA 510(k)
FDA Class 2
·Cardiovascular
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence
FDA 510(k)
FDA Class 2
·Radiology
MULTI SPECT 2 [510(K) K913630]
FDA Adverse Event
Other
·SIEMENS MEDICAL SYSTEMS·Product code IYX·April 13, 2001
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 19, 2013
R/T LOCK NAIL-FEM SE
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LXH·January 31, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 1, 2014
COULTER ACT PAK REAGENT KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·September 24, 2014
COULTER ACT PAK REAGENT KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 26, 2015
COULTER ACT PAK REAGENT KIT
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 5, 2015