10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Captus Vascular Retrieval System
FDA 510(k)
FDA Class 2
·Cardiovascular
INVADER MTHFR 677
FDA 510(k)
FDA Class 2
·Hematology
SENTINEL LITHIUM ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 14, 2013
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 30, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008
CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code DYB·August 31, 2021
CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code DYB·June 8, 2021
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021