69 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MULTILINK HYBRID ABUTMENT CEMENT
FDA 510(k)
FDA Class 2
·Dental
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925018464·FARRIOR RASP .60 MM TIP DIAMETER STAINLESS STEE...
N/A
FDA UDI
Tyber Medical, LLC·M695M1304360·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450333006·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450335680·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450335703·
BIO UNIVERSAL
FDA 510(k)
FDA Class 2
·Dental
CLICKFINE PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 24, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·September 30, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·June 16, 2011
INSPIRE 6F
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025
RESERVOIR INSPIRE 8
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 8, 2026
INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·December 18, 2025
INSPIRE HARD VENOUS RESERVOIR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2022
INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·January 13, 2023
INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES
FDA Adverse Event
SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 19, 2016
INSPIRE HVR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·July 21, 2022