9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fixone All Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
HEALIX ADVANCE
FDA UDI
Medos International Sàrl·10886705030583·HEALIX ADVANCE SP PEEK ANCHOR 4.9mm
EXTERNAL FIXATION RING
FDA 510(k)
FDA Class 2
·Orthopedic
VASU-PICC
FDA 510(k)
FDA Class 2
·General Hospital
SERVO-S
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 10, 2019
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·November 5, 2008
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 13, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 12, 2013
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014