11 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
FDA 510(k)
FDA Class 2
·Microbiology
DYNACORD
FDA UDI
Medos International Sàrl·20886705030054·DYNACORD Suture 1 Blue and 1 White/Blue/Green S...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112588·BARRON CORNEAL PUNCH 6.75MM
HEARTLINE RECEIVING STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
ELI 280 ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THEE PIECE FOLDABLE INTRAOCULAR
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code HQL·November 6, 2008
INTERLOCKING DETACHABLE COIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRD·August 24, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 3, 2014
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