12 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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SDL LISTERIA MONOCYTOGENES CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78405031·Micro Sprint Bracket Roth .018" max. 4+5 right
VertebraLINK
FDA UDI
LINKSPINE, INC.·00817329023531·AO T-Handle with Strike Plate
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78405030051·Micro Sprint Bracket Roth .018" max. 4+5 right
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78405030101·Micro Sprint Bracket Roth .018" max. 4+5 right
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78405031001·Micro Sprint Bracket Roth .018" max. 4+5 right
FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 30, 2014
EXPRESS® LD ILIAC / BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIO·November 20, 2012
ELLIPSE DR ICD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code LWS·June 12, 2015
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018