78 results
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30ms
·
Sources: EU EUDAMED, US FDA
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VaPro Plus Pocket
FDA UDI
HOLLISTER INCORPORATED·00610075054008·No Touch Urethral Intermittent Catheter with In...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540139597·SINUS ELEVATOR, DOUBLE-ENDED, 45 DEGR.
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741124300·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674112430060·
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET
FDA 510(k)
FDA Class 2
·Cardiovascular
Experience
FDA UDI
Gc Orthodontics America Inc.·D78811243000301·EXC XT 022/LR3 -3T 7A 2M
Experience
FDA UDI
Gc Orthodontics America Inc.·E53511243000301·EXC XT 022/LR3 -3T 7A 2M
Experience
FDA UDI
Gc Orthodontics America Inc.·D78811243000101·EXC ROTH 022/LR3 -11T 7A 2M
Experience
FDA UDI
Gc Orthodontics America Inc.·E53511243000101·EXC ROTH 022/LR3 -11T 7A 2M
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·January 3, 2017
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·February 2, 2016
PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWI·January 25, 2017
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 27, 2016
FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 29, 2020
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 14, 2013
OT PING METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Death
·PHILIPS HEALTHCARE·Product code MKJ·May 23, 2011