12 results · 20ms · Sources: EU EUDAMED, US FDA

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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