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