9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Power Wheelchair (YH-E7007)
FDA 510(k)
FDA Class 2
·Physical Medicine
7240638
FDA Adverse Event
Malfunction
·February 5, 2018
PROPELLER SYSTEM - MODEL 2
FDA 510(k)
FDA Class 2
·Anesthesiology
VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPRINT QUATTRO SECURE S
FDA Adverse Event
Death
·MPRI·Product code LWS·November 10, 2014
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 16, 2013
SCULPTRA (POLY-L-LACTIC ACID)
FDA Adverse Event
Malfunction
·SANOFIAVENTIS U.S. LLC·Product code LMH·September 21, 2010
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025