16 results · 29ms · Sources: EU EUDAMED, US FDA

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ABIONIC SA

FDA registration
ABIONIC SA·3 products·🇨🇭 Switzerland

abioSCOPE Control

FDA UDI
Abionic SA·07649996894106·The "abioSCOPE Control" is a control material (...

IVD CAPSULE PSP

FDA UDI
Abionic SA·07649996894021·The IVD CAPSULE PSP is a single-use, rapid in v...

abioSCOPE

FDA UDI
Abionic SA·07649996894014·The abioSCOPE is a table top diagnostic device ...

IVD CAPSULE Control PSP

FDA UDI
Abionic SA·07649996894090·"IVD CAPSULE Control PSP" is a control material...

ADVANCED BIONICS A

FDA Adverse Event
Injury ·ADVANCED BIOONICS·Product code MCM·September 8, 2008

90K ADVANCED BIONICS

FDA Adverse Event
Malfunction ·ADVANCED BIONICS·Product code MCM·August 4, 2004

ILET BIONIC PANCREAS

FDA Adverse Event
Injury ·BETA BIONICS INC·Product code QFG·October 10, 2025

HIRES¿ ULTRA IMPLANT

FDA Adverse Event
Malfunction ·ADVANCED BIONICS, LLC·Product code MCM·May 6, 2022

ILET BIONIC PANCREAS

FDA Adverse Event
Injury ·BETA BIONIC, INC.·Product code QFG·March 14, 2025

CHORUS; BODY-WORN PROCESSOR (ADVANCED BIONICS C1 INTERNAL COCHLEAR IMPLANT)

FDA Adverse Event
Injury ·ADVANCED BIONICS LLC·Product code MCM·August 28, 2025

CHORUS; BODY-WORN PROCESSOR (ADVANCED BIONICS C1 INTERNAL COCHLEAR IMPLANT)

FDA Adverse Event
Injury ·ADVANCED BIONICS LLC·Product code MCM·August 28, 2025

ILET BIONIC PANCREAS

FDA Adverse Event
Injury ·BETA BIONICS·Product code QFG·September 4, 2024

ILET BIONIC PANCREAS

FDA Adverse Event
Injury ·BETA BIONICS·Product code QFG·April 24, 2024

ILET BIONIC PANCREAS

FDA Adverse Event
Injury ·BETA BIONICS·Product code QFG·March 15, 2024

ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).

FDA Recall
Open, Classified ·Intuitive Surgical, Inc.·Product code EOQ·June 10, 2020