9 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
FDA 510(k)
FDA Class 2
·General Hospital
ClearFit
FDA UDI
LONGEVITI NEURO SOLUTIONS LLC·00855113008494·ClearFit OTS 2.4cm Cover
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045841·PrimaLIF LLIF PEEK Implant, 17mm X 26mm X 35mm,...
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
FDA 510(k)
FDA Class 2
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 16, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 14, 2014
Ingenia 3.0T-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: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021