15 results · 22ms · Sources: EU EUDAMED, US FDA

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LDR SPINE ROI-C IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014607146·SKYTRON 3500 3" STANDARD

SYRINGE 20ML LL S/C 48

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·April 28, 2025

HARMONE-SCHWARZER EEG SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

VISION HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Malfunction ·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011

X SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 9, 2013

STARCLOSE SE VASCULAR CLOSURE SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·May 6, 2011

ACRYSOF

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·July 23, 2008

NEEDLE 18X1-1/2 BLUNT FILL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code GAA·April 24, 2025

E-POLY TIBIAL BEARINGS

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JWH·July 12, 2017

NEEDLE 18X1-1/2 BLUNT FILL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code GAA·April 24, 2025

NEEDLE 18X1-1/2 BLUNT FILL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code GAA·April 24, 2025

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018