12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
FDA 510(k)
FDA Class 2
·Neurology
PROFORMA
FDA UDI
Conmed Corporation·20653405051296·PROFORMA Cannula, Short Tapered Tip, Straight
AngioSystems Tray
FDA UDI
ANGIOSYSTEMS, INCORPORATED·00816611026397·
EndoAVF® Balloon Inflation Kit
FDA UDI
Merit Medical Systems, Inc.·00884450413838·
WAKO AUTOKIT C4
FDA 510(k)
FDA Class 2
·Immunology
L.A.M. IPM WOUND GEL
FDA 510(k)
FDA Unclassified
·Unknown
audifon
FDA UDI
audifon GmbH & Co. KG·EADF021338805032517201·BTE-TRT
UNKNOWN MAGNUM HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 10, 2013
YOYAGER RX CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·May 22, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 12, 2011
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018