10 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
LEONE SPA
FDA UDI
LEONE SPA·08033707065708·INTRAORAL ELASTICS 4,5 oz 1/4" red
COPPERHEAD CERVICAL INTERBODY CAGE
FDA Adverse Event
Injury
·EMINENT SPINE·Product code ODP·January 8, 2016
INTRASTENT DOUBLESTRUT XS STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANALYST PANELS + ANALYTICAL TEST ROTOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2024
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013
OPTICROSS?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·September 15, 2014
4.5MM LCP PROXIMAL FEMUR PLATE 8 HOLES/247 MM-LEFT
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·May 11, 2011
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017