12 results
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20ms
·
Sources: EU EUDAMED, US FDA
Vivo 45 LS
FDA 510(k)
FDA Class 2
·Anesthesiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517630650·CoRoent Ant TLIF Ti, 13x12x36mm 15°
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113394·MICS TRAP KNIFE 1.8/2.2 (BX/5)
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102657·FUKASAKU LIEBERMAN SPATULA, LEFT
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
FDA 510(k)
FDA Class 2
·Orthopedic
BENZODIAZEPINE ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 10, 2024
ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEX·September 2, 2011
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 15, 2014
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·AVENT SA DE R.L. DE C.V.·Product code HEB·December 11, 2012
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