DDM Ferring Drug Delivery System

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Insulet Corporation·1 device

Spinal Pedicle Screw, Fixation, Appliance System

FDA Pre-Market Approval

FDA Class 3 ·SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VISTA 4, 6, & T; DELTA T & TRS; VISTA DD; AND VIGOR DDD

NephroCam

Basic UDI-DI

EU MDD · Eu Md Class 2a ·DDD-Diagnostic A/S·1 device

QuantumCam

Basic UDI-DI

EU MDD · Eu Md Class 2a ·DDD-Diagnostic A/S·1 device

SoloMobile

Basic UDI-DI

EU MDD · Eu Md Class 2a ·DDD-Diagnostic A/S·1 device

CardioMD IV

Basic UDI-DI

EU MDD · Eu Md Class 2a ·DDD-Diagnostic A/S·1 device

CorCam

Basic UDI-DI

EU MDD · Eu Md Class 2a ·DDD-Diagnostic A/S·1 device

Solo

Basic UDI-DI

EU MDD · Eu Md Class 2a ·DDD-Diagnostic A/S·1 device

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BODYSTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

VENTURI MiNO TG600/14

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Spiral Flow Peripheral Vascular Graft

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

FDA 510(k)

FDA Class 2 ·Immunology

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

DISTAT ANTI-DSDNA KIT

FDA 510(k)

FDA Class 2 ·Immunology

REMOTE VIEW SOFTWARE

FDA 510(k)

FDA Class 2 ·Dental

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-CARDIOLIPIN KIT

FDA 510(k)

FDA Class 2 ·Immunology