11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTEGRA CAMINO ICP MONITOR
FDA 510(k)
FDA Class 2
·Neurology
QUANTA SYSTEM S. P. A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 9, 2014
ACCUSCULPT II LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
FDA 510(k)
FDA Class 2
·Anesthesiology
BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 16, 2025
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·May 21, 2013
PALINDROME 19/36 KIT W/ SLOT
FDA Adverse Event
Malfunction
·COSTA RICA·Product code MSD·September 26, 2014
PFC KEEL TIB TRAY CEM SZ4
FDA Adverse Event
Injury
·DEPUY-CORK A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·June 2, 2011
WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·August 9, 2022
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022