11 results · 21ms · Sources: EU EUDAMED, US FDA

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Viz HDS, Viz Volume Plus, Viz ICH+

FDA 510(k)
FDA Class 2 ·Radiology

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776202996·LIEBERMAN DOUBLE ENDED MICROFINGERL

Ophthalmic Spatula

FDA UDI
KATENA PRODUCTS, INC.·00841668102633·LIEBERMAN DOUBLE ENDED MICROFINGER, LEFT

ZOLL M SERIES NIBP OPTION

FDA 510(k)
FDA Class 2 ·Cardiovascular

DOLPHIX EXTERNAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PORTEX® DISPOSABLE ANESTHESIA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code CAI·December 6, 2016

MEDI-TRACE 535 FOAM ELECTRODES

FDA Adverse Event
Malfunction ·COVIDIEN KENDALL·Product code DRX·November 2, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

FDA Enforcement
Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025