132 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AXLE INTERSPINOUS FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776172473·TC REUL TISSUE FCP
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925018488·FARRIOR CHISEL 30 DEGREE BLADE ANGLE 1.27 MM BL...
N/A
FDA UDI
Tyber Medical, LLC·M695M1304380·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450329627·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197046497·Delicat Forceps
angled...
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BARD AQUAGUIDE URETERAL CONDUIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VALIANT CAPTIVIA
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·May 24, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·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
INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·September 5, 2019
INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·July 4, 2019