22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS®-A
FDA UDI
SpineArt SA·07640375238139·TALOS®-A (HA) PEEK PLANAR, ASYMMETRIC IBFD D26 ...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946012151·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946005764·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167322414110·
X SERIES
FDA UDI
Zoll Medical Corporation·00847946006341·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946018917·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946062415·X SERIES, ALS, 12 LD, PACE, SPO2, SPCO, SPMET, ...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946019372·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167312414110·
Visage Breast Density
FDA 510(k)
FDA Class 2
·Radiology
MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP
FDA 510(k)
FDA Class 2
·Cardiovascular
X SERIES
FDA UDI
Zoll Medical Corporation·00847946018238·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946062422·X SERIES, ALS, 12 LD, PACE, SPO2, SPCO, SPMET, ...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946012168·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...
X SERIES
FDA UDI
Zoll Medical Corporation·00847946029937·X SERIES, ALS, 12 LD, PACE, SPO2, SPCO, SPMET, ...
PFC SIGMA MOD TIB TRAY CEM SZ2
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code JWH·November 10, 2014
INFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 18, 2011
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 2013
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014