70 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
RADIAL HEAD IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00126441·
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
FDA 510(k)
FDA Class 2
·Ophthalmic
SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·January 9, 2025
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 14, 2013
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·February 9, 2011
ACCU-CHEK MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·February 8, 2008
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·August 7, 2019
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
FDA Enforcement
Class II
·Terminated·Physician Engineered Products, Inc.·September 9, 2015
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 7, 2022
GLIDESHEATH
FDA Adverse Event
Death
·TERUMO MEDICAL CORPORATION·Product code DYB·September 6, 2023
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 1, 2020
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·May 19, 2022
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·January 21, 2022
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·September 28, 2023
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 25, 2020
RADIFOCUS INTRODUCER
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·June 29, 2020
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·November 25, 2014