12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine
FDA 510(k)
FDA Class 2
·Clinical Toxicology
STRATOFUSE Strip
FDA UDI
BERKELEY ADVANCED BIOMATERIALS, LLC·00816125023462·STRATOFUSE is a sterile bone graft composed of ...
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837088835·
GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
FDA 510(k)
FDA Class 2
·Orthopedic
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 8, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013
AMS 700 INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAE·June 28, 2011
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
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