71 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC
FDA 510(k)
FDA Class 2
·Orthopedic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776413200·Angled Pick Round Knurled Handle, 30 Degree Ang...
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925018440·FARRIOR PICK 90 DEGREE TIP ANGLE, UP .60 MM TIP...
N/A
FDA UDI
Tyber Medical, LLC·M695M1304340·
3B FLEX-LITE
FDA 510(k)
FDA Class 2
·Anesthesiology
CLAVE NEUTRON
FDA 510(k)
FDA Class 2
·General Hospital
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 24, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 30, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·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
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018
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
SORIN GROUP ITALIA SRL·Product code DTZ·October 5, 2016
INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOT
FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTZ·November 4, 2016