8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CLINICOMP R.C.I.
FDA 510(k)
FDA Class 2
·Radiology
PHILIPS IU22 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
FDA 510(k)
FDA Class 2
·Radiology
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 22, 2014
ALAIR BRONCHIAL THERMOPLASTY CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SAN JOSE·Product code OOY·November 21, 2012
FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1,TRANS.
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·September 1, 2010
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018