13 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SLM-1ER, SLM-2ER, SLM-3ER
FDA 510(k)
FDA Class 2
·Ophthalmic
LANX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OCCLUSION BALLOON CATHETER MODEL OBC
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
DIMENSION(R) CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code JIT·June 17, 2013
8 HOLE FOOTPIECE SET IN 5 IN WHEEL
FDA Adverse Event
Malfunction
·A & E INDUSTRIES·Product code ITJ·March 10, 2007
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·Product code DQX·May 21, 2021
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·December 28, 2021
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 17, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·October 3, 2023
APPROACH CTO MICROWIRE WIRE GUIDE
FDA Adverse Event
Injury
·COOK INC·Product code DQX·October 31, 2023
LILLIPUT 2
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·November 3, 2023
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