836 results
·
17ms
·
Sources: EU EUDAMED, US FDA
Etymotic Research, Inc.
FDA UDI
ETYMOTIC RESEARCH, INC.·00846430004023·Home Hearing Test
8" EXT SET WITH 0.2 MICRON FILTER, CLAMP, ROTATING LUER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·December 14, 2025
HHT-LLD SCM retrofit kit
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·On the market
c8100 HHT/Sysmex TrayLane Arm cover
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·On the market
AMPLATZER AMULET
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NGV·February 2, 2026
AMPLATZER AMULET
FDA Adverse Event
Death
·ABBOTT MEDICAL·Product code NGV·February 2, 2026
LEVEL 1
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code LGZ·April 30, 2021
c8100 HHT +1 tray IPB/OBS mod kit
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·On the market
c8100 HHT 2 tray IPB/OBS mod kit
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·On the market
c8100 HHT 1 tray IPB/OBS mod kit
Device
EU IVDR
·
Eu Ivd Class A
·Hitachi High-Tech Corporation·On the market
DREAMSTATION BIPAP AUTOSV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·August 29, 2025
IMPELLA CP
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·November 21, 2024
ONYX
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·February 7, 2023
BYTE DAY ALIGNERS
FDA Adverse Event
Malfunction
·STRAIGHT SMILE, LLC·Product code NXC·November 5, 2024
DREAMSTATION BIPAP AUTOSV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 2, 2023
DREAMSTATION BIPAP ST30
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·December 28, 2023
DREAMSTATION ST30 H/HT
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·July 21, 2022
DREAMSTATION BIPAP ST
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·December 6, 2023
DREAMSTATION BIPAP AUTOSV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·December 6, 2023
14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·May 21, 2025