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