16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDOPLUS hand-held laparoscopic instruments
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ProLift
FDA UDI
Life Spine, Inc.·00190837117603·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111175381·MAYO DISS SCISS STR 6.75"
ZB ProLift Narrow
FDA UDI
Life Spine, Inc.·00190837079345·
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·October 2, 2018
SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
APTUS TITANIUM OSTEOSYNTHESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 15, 2018
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 7, 2013
GORE VIABAHN ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCAITES·Product code NIP·June 29, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
GMK PRIMARY CEMENTED NARROW FEMUR SIZE 4 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 27, 2015
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