26 results · 34ms · Sources: EU EUDAMED, US FDA

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HERO

FDA 510(k)
FDA Class 2 ·Cardiovascular

CD HORIZON® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074364438·4.5/6.35 CLS LAT CON, 30MM,SS

TMM-EDC-L

FDA UDI
Altitude Technologies Inc.·00850062467002·TMM Everyday Carry Lite first aid module is a v...

Vatech Clismile

FDA UDI
Rayence Co., Ltd.·08800018601402·This product is an orthodontic bracket and is u...

ULTRAPOWER

FDA UDI
Conmed Corporation·10845854006955·ULTRAPOWER BUR, ROUND (MUSTARD) 6.5 MM

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0112300·Tap, 8.5mm Cortical, SNI1

DIASOL-BICARB

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PHEM-ALERT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 24, 2025

ENDOWRIST ONE VESSEL SEALER

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC.·Product code NAY·March 21, 2013

SPRINT FIDELIS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·March 28, 2008

SORIN BIOMEDICA SMARXT BCD VANGUARD

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·November 20, 2019

SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·November 16, 2016

MUSC CHARLESTON SC 1

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DWF·March 28, 2012

SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTR·October 28, 2016

SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·April 27, 2023

SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·December 15, 2023

SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·November 2, 2016

SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM

FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTR·October 28, 2016