70 results · 28ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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