10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
8 EMESIS BASIN
FDA 510(k)
FDA Class 1
·General Hospital
NA
FDA UDI
KEY SURGICAL, INC.·10849771050084·Steinmann Pins, Double diamond, threaded, 3/32-...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704294019·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771015345·Steinmann Pins, Double diamond, threaded, 3/32-...
TrueBeam, TrueBeam STx, Edge
FDA 510(k)
FDA Class 2
·Radiology
DL900 SERIES HOLTER RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·April 24, 2014
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·June 28, 2007
C-FLEX
FDA Adverse Event
Malfunction
·RAYNER INTRAOCULAR LENSES LIMITED·Product code HQL·October 1, 2012
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018