11 results
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21ms
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Sources: EU EUDAMED, US FDA
PLASMA POOLER HEAT SEALER
FDA 510(k)
FDA Class 1
·Hematology
VistaTablet
FDA UDI
Vital Connect, Inc.·00850490007429·VistaTablet Relay Device
Lynx Cross Connector
FDA UDI
Life Spine, Inc.·00190837005924·
Lynx Cross Connector
FDA UDI
Life Spine, Inc.·00190837005931·
MODIFICATION TO VISTA STEREOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDIGUIDE TECHNOLOGY
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2014
FACETFUSE DRILL
FDA Adverse Event
Malfunction
·SPINEFRONTIER·Product code MRW·October 31, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 30, 2010
BONE PLATE, MP, 4 HOLE, MEDIUM BAR
FDA Adverse Event
Injury
·STRYKER LEIBINGER FREIBURG·Product code JEY·January 31, 2019
Ingenia 3.0T CX-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: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021