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