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

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Demi Ultra

FDA 510(k)
FDA Class 2 ·Dental

Ceramco® II Silver™

FDA UDI
Dentsply International Inc.·D0011630640·

AVAMAX VERTEBRAL BALLOON

FDA 510(k)
FDA Class 2 ·Orthopedic

MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

STARKEY

FDA UDI
Starkey Laboratories, Inc.·00842318177001·

RESTORE ULTRA

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·November 6, 2012

SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 11, 2016

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 4, 2014

POLYFORM SYNTHETIC MESH

FDA Adverse Event
Injury ·PROXY BIOMEDICAL LTD.·Product code FTL·May 28, 2013

ENDOTAK ENDURANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·July 15, 2011

CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code KRH·September 15, 2008

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 30, 2012

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 1, 2020

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 3, 2013

GLIDEWIRE ADVANTAGE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 9, 2025

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 23, 2022

INTELLIS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 27, 2024

RESTORE ULTRA

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 16, 2012

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 3, 2025

RADIFOCUS GUIDEWIRE ADVANTAGE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 12, 2024