10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRICYCLIC ANTIDEPRESSANT II TX CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100286·KIT, EXPEDITIONARY CASUALTY RESPONSE
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209134663·
SENOJ IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
KODAK 9000C EXTRAORAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
FREESTYLE
FDA Adverse Event
Malfunction
·Product code LFR·May 8, 2014
TUNNELLING TOOL
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 18, 2012
DEPUY
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC.·Product code JDI·August 9, 2010
Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.
FDA Enforcement
Class II
·Ongoing·Genesee BioMedical, Inc.·June 6, 2018
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021