2,923 results
·
41ms
·
Sources: EU EUDAMED, US FDA
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Evera/MRI/DF, ICD, S DR, XT DR, S VR, XT VR, Maximo II ICD, Secura DR ICD/ DR, Visia AF MRI DFI ICD/VR ICD
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Evera MRI DF ICD /MRI ICD / S DR / S VR / XT DR /XT VR ICD's; Visia AF MRI DFI ICD / AF MRI VR ICD / AF VR ICD.
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Evera MRI DF-I ICD,EVERA MRI ICD, Evera S DR/S VR/XT DR/ XT VR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maxmo II ICD,
Disposable analog thermometer covers
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·EQUA OÜ·1 device
FBI Medizintechnik GmbH
Importer
🇩🇪 Germany·1 Manufacturer
HX 2028254-1
Certificate
IVDR QMS·DFI Co.,Ltd.·TÜV Rheinland LGA Products GmbH
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Evera MRI DF-I ICD/Evera MRI ICD/ Evera S DR ICD/Evera S VR ICD/ Evera XT DR ICD/ Evera XT VR ICD/ Visia AF MRI DF1 ICD/
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Evera MRI DF-I ICD / Evera MRI ICD/ S DR ICD / S VR ICD / XT DR ICD /XT VR ICD ; Mirro MRI DR ICD / MRI VR ICD; Primo MR
Cliniview
FDA 510(k)
FDA Class 2
·Radiology
ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)
FDA 510(k)
FDA Class 2
·Orthopedic
ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
FDA 510(k)
FDA Class 2
·Orthopedic
E-EEGX, N-EEGX
FDA 510(k)
FDA Class 2
·Neurology
ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM
FDA 510(k)
FDA Class 2
·Orthopedic
CARESCAPE B450
FDA 510(k)
FDA Class 2
·Cardiovascular
ACTIVASCREW
FDA 510(k)
FDA Class 2
·Orthopedic
CARESCAPE B450, E-musb
FDA 510(k)
FDA Class 2
·Cardiovascular
Steriking® LT-Blueline Pouches with Tyvek®
FDA 510(k)
FDA Class 2
·General Hospital
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
FDA 510(k)
FDA Class 2
·Anesthesiology
Icare ic100
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
FDA 510(k)
FDA Class 2
·Anesthesiology