13 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
FDA 510(k)
FDA Class 2
·Radiology
ComfortGel Blue
FDA UDI
Respironics, Inc.·00606959043909·ComfortGel Blue Full Mask, Extra Large, Japan
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GENZYME DIRECT-AMYLASE TEST REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2025
UNKNOWN COPELAND SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·April 14, 2017
COPELAND SH HUM SZ4 STND PLUS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·June 8, 2016
UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·October 21, 2016
UNKNOWN COPELAND RESURFACING SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·May 16, 2017
UNKNOWN COPELAND SHOULDER GLENOID COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·July 5, 2017
DRILL/TAP AND SCREW GUIDE WITH HANDLE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZX·April 29, 2013
TRUETRACK
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·April 5, 2011
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code KRH·July 17, 2008