10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
AVANOS
FDA UDI
Avanos Medical, Inc.·00193493928835·AVANOS* Nerve Block Trays
Halyard
FDA UDI
Avanos Medical, Inc.·10680651928839·
Lateral Patient Positioning System
FDA UDI
ALPHATEC SPINE, INC.·00190376484051·Thoracic Base Pad
FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
FDA 510(k)
FDA Class 2
·Cardiovascular
WART FREEZE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 1, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 20, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·September 29, 2008
Ingenia 1.5T S-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 Model: 781347
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021