8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CERTAIN HB CO-OXIMETER CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTHERA SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·May 27, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 9, 2012
GIA UNIVERSAL
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·September 8, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023