10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
AIR UTERINE DISPLACER-AUD 120
FDA 510(k)
FDA Class 1
·Anesthesiology
Masel
FDA UDI
Ortho Organizers, Inc.·00190707034931·.016 X .022 Lower Elastinol™ Natural Orthocosme...
AGILE NAIL
FDA UDI
ORTHOFIX SRL·18056099649032·AGILE NAIL TI PEG SCREW L22MM D3.2MM STERILE
PROTEMP 3 GARANT
FDA 510(k)
FDA Class 2
·Dental
ZEDVIEW
FDA 510(k)
FDA Class 2
·Radiology
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 27, 2014
X7000 XENON LIGHTSOURCE
FDA Adverse Event
Injury
·STRYKER ENDOSCOPY SAN JOSE·Product code FSS·November 1, 2012
COOK CELECT FEMORAL VENA CAVA FILTER
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·July 19, 2010
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018