11 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ST. MARK'S RECTAL BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788224010·Cervical Trial + DS 6x12x12 Flat
Halyard
FDA UDI
O&M HALYARD, INC.·20680651682240·HALYARD,H400,STRWRP,-,24X24,250
TANGO M2 BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PTS PANELS MULTI-CHEMISTRY CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 20, 2014
ASR UNI FEMORAL IMPL SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 7, 2012
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code LFL·August 17, 2007
Ingenia Ambition 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 Models: 781359
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025