14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medline ENFit Connectors
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ProLift
FDA UDI
Life Spine, Inc.·00190837105938·Static Expandable Cage Trial, 12mm x 28mm x 12m...
INFINITY MONITORS WITH SCIO MODIFICATIONS
FDA 510(k)
FDA Class 2
·Cardiovascular
KOWA NONMYD WX
FDA 510(k)
FDA Class 2
·Ophthalmic
PENUMBRA SYSTEM MAX ASPIRATION TUBING
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·June 24, 2015
BD ANGIOCATH¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 19, 2017
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 8, 2014
ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEX·June 7, 2013
CORTEX SCREW S.T. 4.5X40MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS SELZACH·Product code HRS·June 29, 2011
BD ANGIOCATH IV CATHETER 20GA 1.88IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·June 24, 2020
BD INSYTE¿ PERIPHERAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·March 20, 2018
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
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