149 results · 33ms · Sources: EU EUDAMED, US FDA

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URISYS 2400 URINE TEST STRIP

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Zirlux

FDA UDI
HENRY SCHEIN, INC.·H65890123970·Zirlux Shading Liquid - incisal for painting te...

CERASMART®

FDA UDI
Gc America Inc.·D0470123971·CERASMART 270 12 A2 HT CEREC 5p

CERASMART®

FDA UDI
Gc America Inc.·14548161320047·CERASMART™ 270 12 Cerec A2 HT 5p Block

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033400302·

M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER

FDA 510(k)
FDA Class 2 ·Radiology

PERSYST REVEAL

FDA 510(k)
FDA Class 2 ·Neurology

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·February 25, 2020

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R E-CROSS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 19, 2022

LIBERTY CYCLER

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·March 13, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·March 9, 2011

PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·August 15, 2014

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·November 6, 2019

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·July 30, 2019

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·April 2, 2019

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·April 2, 2019

KYPHX HV-R BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·January 9, 2020

ACTIVOS¿ BONE CEMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·October 22, 2024

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·CARDIAC SURGERY MFG KERKRADE·Product code NDN·November 10, 2025

KYPHON XPEDE BONE CEMENT

FDA Adverse Event
Malfunction ·CARDIAC SURGERY MFG KERKRADE·Product code NDN·November 10, 2025