10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Handheld Pulse Oximeter, Model SP-20
FDA 510(k)
FDA Class 2
·Cardiovascular
ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
DISPOSABLE BLOOD PRESSURE CUF
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 7, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 18, 2024
JUVEDERM VOLUMA XC 27G 2X 1ML
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·October 10, 2014
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 22, 2011
SECURE ACUTE CARE BED 3/01
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 17, 2013
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·April 16, 2024
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018