27 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Venue
FDA 510(k)
FDA Class 2
·Radiology
SpheRx
FDA UDI
Nuvasive, Inc.·00887517099075·SpheRx II Base, Hook/Fixed Screw Tray
COE TRAY PLASTIC™
FDA UDI
Gc America Inc.·10386040006422·COE TRAY PLASTIC™ Professional Package, Fast Se...
COE TRAY PLASTIC™
FDA UDI
Gc America Inc.·D6582401111·COE TRAY PLASTIC™ Professional Package, Fast Se...
Edgewise Rotating Spring
FDA UDI
TP ORTHODONTICS INC·00192029027721·CCW Medium
Cflex Reduce Full Leg SM SM SM Tall Left Black
FDA UDI
SIGVARIS INC·00745129331603·Inelastic garment (or accessory) made of nylon ...
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT
FDA 510(k)
FDA Class 2
·Microbiology
Cflex Reduce Full Leg SM SM SM Tall Right Black
FDA UDI
SIGVARIS INC·00745129331689·Inelastic garment (or accessory) made of nylon ...
Cflex Reduce Full Leg SM SM SM Reg Left Black
FDA UDI
SIGVARIS INC·00745129331641·Inelastic garment (or accessory) made of nylon ...
Cflex Reduce Full Leg SM SM SM Reg Right Black
FDA UDI
SIGVARIS INC·00745129331726·Inelastic garment (or accessory) made of nylon ...
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 24, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2013
LIBERTY CYCLER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·May 2, 2013
SOLERA DRIVER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code OLO·August 7, 2024
PENUMBRA SMART COIL DETACHMENT HANDLE
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·October 26, 2021
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·October 26, 2021
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·October 26, 2021
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·October 26, 2021