13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)
FDA 510(k)
FDA Class 2
·Cardiovascular
DIMENSION GARANT L, DIMENSION GARANT L QUICK
FDA 510(k)
FDA Class 2
·Dental
ELECSYSCA 15-3 II ASSAY
FDA 510(k)
FDA Class 2
·Immunology
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ICU MEDICAL MANUFACTURING S.A. DE C.V.·Product code FPA·October 28, 2025
CADD CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·ICU MEDICAL MANUFACTURING S.A. DE C.V.·Product code FPA·October 28, 2025
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC·Product code FPA·September 10, 2025
CADD MEDICATION CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·July 28, 2025
CADD MEDICATION CASSETTE RESERVOIR
FDA Adverse Event
Malfunction
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·July 28, 2025
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 28, 2025
ZIMMER DOUGH-TYPE BONE CEMENT 40GM/20ML
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code LOD·April 17, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 27, 2011
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·July 2, 2008
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015