Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI XT DR/VR SURESCAN,EVERA MRI S DR/VR SURESCAN ICDS AND PROGRAMMER SOFTWARE

FDA Pre-Market Approval

MEDTRONIC GEMIII DR MODEL 7275 (ICD), MODEL 9970 PROGRAMMER APPLICATION SOFTWARE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera/Visia AF MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III AT 7276

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ARTIC FRONT CARDIC CRYOABLATION CATHETERS, ARTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS, FREEZOR MAX CARIAC CRYOAB

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S(DR/VR) ICD, EVERA XT (DR/VR) ICD, MAXIMO II ICD, PROTECTA (XT)ICD,SECURA ICD, VIRTUOUSO II(DR/VR) ICD

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Transvene CS/SVC Lead

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance Cardiac CryoAblation Catheters

BUREAU VERITAS ITALIA S.P.A.

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🇮🇹 Italy·51 Manufacturers·434 Basic UDI-DIs

Intertek Medical Notified Body AB

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🇸🇪 Sweden·12 Manufacturers·2 Basic UDI-DIs

Eurofins Electric & Electronics Finland Oy

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🇫🇮 Finland·78 Manufacturers·851 Basic UDI-DIs

INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

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🇨🇿 Czechia·16 Manufacturers·135 Basic UDI-DIs

ISTITUTO SUPERIORE DI SANITA'

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🇮🇹 Italy·155 Manufacturers·506 Basic UDI-DIs

ICIM S.P.A.

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🇮🇹 Italy·32 Manufacturers·86 Basic UDI-DIs

DQS Medizinprodukte GmbH

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🇩🇪 Germany·144 Manufacturers·6387 Basic UDI-DIs

QMD Services GmbH

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🇦🇹 Austria·6 Manufacturers·1 Basic UDI-DI

POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

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🇵🇱 Poland·272 Manufacturers·5185 Basic UDI-DIs