10 results · 36ms · Sources: EU EUDAMED, US FDA

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NEUTROLUMENPN SYSTEM, MODEL 1000

FDA 510(k)
FDA Class 2 ·Physical Medicine

EPIC SPO2 FINGER SENSOR, MODEL E412-20

FDA 510(k)
FDA Class 2 ·Cardiovascular

CG-2211 SELFCHECK ECG TRANSMITTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 25, 2025

NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX

FDA Adverse Event
Death ·ATRICURE, INC.·Product code OCL·November 13, 2018

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·April 29, 2013

2.7 MM THREADED DRILL GUIDE

FDA Adverse Event
DEPUY·Product code LXH·April 29, 2011

UNKNOWN

FDA Adverse Event
Death ·MEDTRONIC NEUROMODULATION·Product code LNQ·July 25, 2008

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