15 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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SYNTHES 7.0/7.3 MM CANNULATED SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·May 18, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 27, 2015
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295240570·P.F.C. SIGMA TIBIAL INSERT FIXED BEARING CURVED...
MedDream
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO FLOWSCREEN
FDA 510(k)
FDA Class 2
·Anesthesiology
LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
FDA 510(k)
FDA Class 2
·Dental
UNKNOWN
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 9, 2024
UNKNOWN
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 9, 2024
UNKNOWN
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 9, 2024
T:FLEX INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·July 31, 2015
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·January 23, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 28, 2014
PFC SIGMARP CV TB/IN S2 10.0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code NJL·October 10, 2017
1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of the internal structures of the head or body. The images produced by the signa Horizon Cx System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010