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