IMMUNOGLOBULIN A TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MID-LEVEL IGG KIT CAT. NO. 9315

FDA 510(k)

FDA Class 1 ·Immunology

OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

ANTITHROMBIN III RIA

FDA 510(k)

FDA Class 2 ·Hematology

MONOCLONAL RADIAL IMMUNODIFFUSION KIT

FDA 510(k)

FDA Class 2 ·Immunology

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·QUARTET IS4 LEAD MODELS 1458Q

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Tachy DF4 header core

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DURATA DF-4 LEAD MODELS 7120Q, 7121Q, 7170Q, 7171Q, 7172Q

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Tachy DF4 header core

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DURATA LEADS

Plexa ProMRI

FDA UDI

BIOTRONIK SE & Co. KG·04035479151027·

Plexa ProMRI

FDA UDI

BIOTRONIK SE & Co. KG·04035479151034·

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Protego EP PASSION

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Protego EP PASSION

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PROTEGO FAMILY OF ICD LEADS

Partial Flex

FDA registration

CLEMDE S.A. DE C.V.·1 product·🇲🇽 Mexico

PF Keep / Cad Cam Peek Block

FDA registration

CLEMDE S.A. DE C.V.·3 products·🇲🇽 Mexico

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·ICD INOGEN CRT-D DF4/IS1, ICD INOGEN CRT-D DF/IS1/IS1, ICD INOGEN CRT-D DF1/IS1/IS4, ICD INOGEN CRT-D DF4/IS1/IS4, ICD D

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IPERIA 7 VR-T/INVENTRA 7 VR-T (DF-1); IPERIA 7 VR-T/INVENTRA 7 VR-T (DF4)