29 results
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20ms
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Sources: EU EUDAMED, US FDA
ELECSYS PRECICONTROL VARIA 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380077357·1.1mm Non-Threaded Guide Wire 150mm
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089476541·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033399·Coupling Treatment Tube for 4F Flexibles (6)
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122223·KWire .045x6" (1.1x150mm)
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122216·KWire .045x6" (1.1x150mm) Threaded
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321115060·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311115060·
OMNILINK .035 BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 13, 2024
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
RADIAL JAW TM4
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code KGE·May 2, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
RADIESSE DERMAL FILLER
FDA Adverse Event
Other
·MERZ AESTHETICS, INC.·Product code LMH·May 20, 2011
G7 BONEMASTER LTD ACET SHL 50D
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·May 22, 2024
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 12, 2015
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 12, 2015
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 12, 2015
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021