8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOBBS MEDICAL POLYPECTOMY SNARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PERCUTANEOUS SHEATH INTRODUCER TRAY
FDA 510(k)
FDA Class 2
·Cardiovascular
KV BLOOD AGAR PLATE
FDA 510(k)
FDA Class 1
·Microbiology
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 23, 2025
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 2, 2014
SYNCHROMED EL
FDA Adverse Event
Death
·RICE CREEK MFG·Product code LKK·November 25, 2012
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 15, 2015
VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025