11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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