26 results · 23ms · Sources: EU EUDAMED, US FDA

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Q13 SPIROLYSER®

FDA 510(k)
FDA Class 2 ·Anesthesiology

CLEARARCH

FDA 510(k)
FDA Class 2 ·Dental

RIGIDOMETER, MODEL DIR-4U

FDA 510(k)
FDA Unclassified ·Unknown

SAPPHIRE M.T INFUSION PUMP - FRENCH

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·December 23, 2024

UNKNOWN SAPPHIRE PUMP

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·August 6, 2025

SAPPHIRE M.T INFUSION PUMP - FRENCH

FDA Adverse Event
Injury ·EITAN MEDICAL LTD.·Product code FRN·March 17, 2026

SAPPHIRE M.T INFUSION PUMP - FRENCH

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·May 26, 2026

UNKNOWN SAPPHIRE PUMP

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·February 2, 2026

SAPPHIRE M.T INFUSION PUMP - GERMAN

FDA Adverse Event
Death ·EITAN MEDICAL LTD.·Product code FRN·April 28, 2025

SAPPHIRE M.T INFUSION PUMP - FRENCH

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 24, 2025

KRD DEVICE, EMBOLIZATION, VASCULAR

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·September 19, 2019

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013

REALIZE ADJ GASTRIC BAND STR

FDA Adverse Event
Injury ·OBTECH MEDICAL SARL·Product code LTI·September 16, 2008

ARTOURA BREAST TISSUE EXPANDER

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·March 31, 2020

RETRACTA DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·June 20, 2019

ARTOURA BREAST TISSUE EXPANDER

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·May 26, 2022

ARTOURA BREAST TISSUE EXPANDER

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·October 10, 2020

RETRACTA DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·September 17, 2018

RETRACTA DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·September 17, 2018