14 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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Zenition 30
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Medos International Sàrl·10886705011322·FULLY FLUTED REAMER, STERILE 40 - 130mm (Plus o...
DePuy Mitek
FDA UDI
Provision·B504OM2324200·
OsteoMed
FDA UDI
OSTEOMED LLC·00842528123263·20mm Circular Metatarsal Reamer
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102954·PISACANO NUCLEUS ROTATOR HORIZONTAL
TP Original Wire
FDA UDI
TP ORTHODONTICS INC·00192029028902·Premier Round
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COBE SPECTRA
FDA Adverse Event
Malfunction
·GAMBRO BCT·Product code GKT·February 27, 2003
MOSS MIAMI SI FINAL TIGHTENER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code HXX·November 6, 2014
CONTOUR
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·August 26, 2011
DEPUY DUOFIX MBT TRAY SZ 4
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code NJL·July 18, 2013
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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