19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Prestige
FDA 510(k)
FDA Class 2
·Dental
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837088446·
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·July 8, 2013
BD DIRECTIGEN EZ RSV
FDA 510(k)
FDA Class 1
·Microbiology
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO HEALTHCARE EQUIPMENT·Product code IOR·October 14, 2014
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code NAY·January 11, 2019
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code NAY·January 11, 2019
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code OLO·March 13, 2019
10.5CM ANGLE ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 8, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 7, 2013
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)2-M-TE4BE1AB
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, IRVINE·Product code OAD·June 21, 2011
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code OLO·April 10, 2019
ROSA ONE
FDA Adverse Event
Injury
·MEDTECH SA·Product code OLO·February 22, 2019
ROSA ONE
FDA Adverse Event
Injury
·MEDTECH SA·Product code OLO·March 11, 2019
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code NAY·April 3, 2019
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