149 results · 24ms · Sources: EU EUDAMED, US FDA

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SONIXTABLET ULTRASOUND SCANNER

FDA 510(k)
FDA Class 2 ·Radiology

COLLATEK FOAM

FDA 510(k)
FDA Unclassified ·Unknown

FIESTA IMAGING OPTION

FDA 510(k)
FDA Class 2 ·Radiology

KYPHX HV-R BONE CEMENT

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

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·December 18, 2018

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·December 18, 2018

ALERE DETERMINE HIV 1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·December 18, 2018

ALERE DETERMINE HIV-1/2 AG/AB COMBO

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MZF·August 13, 2019

PROLIFT PELVIC FLOOR REPAIR

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTP·May 9, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·September 19, 2014

COULTER® LH 750

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·May 25, 2011

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

KYPHON® ACTIVOS¿ BONE CEMENT WITH HYDROXYAPATITE

FDA Adverse Event
Malfunction ·CARDIAC SURGERY MFG KERKRADE·Product code NDN·November 29, 2024