14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reform Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
ProLift
FDA UDI
Life Spine, Inc.·00190837086169·
Prime Medical LLC
FDA UDI
Prime Medical LLC·00850055249295·PrimePadPlus-K15-3422
THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
SROM*STM ST,36+8L NK,22X17X165
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code JDI·April 2, 2012
SPECIAL EVD 10-110 W/O Y SITE
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·January 6, 2016
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
EASYTRAK 3
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·July 6, 2011
PLMA DVC V11.51 1 N
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD·Product code FRN·May 30, 2013
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016