OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

FPR GENTAMICIN CALIBRATOR KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

EP Tracer

FDA registration

CARDIOTEK BV·1 product·🇳🇱 Netherlands

EP-TRACER

FDA registration

CARDIOTEK BV·1 product·🇳🇱 Netherlands

EP-Tracer System

FDA registration

CARDIOTEK BV·1 product·🇳🇱 Netherlands

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse DR, Ellipse VR

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

FDA Pre-Market Approval

FDA Class 3 ·Avant, Entrant, Gallant, Neutrino NxT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Entrant, Gallant, Neutrino NxT

CREED™ Cannulated Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

FusionFrame Ring Lock System

FDA 510(k)

FDA Class 2 ·Orthopedic

Apollo Ankle Fracture Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

PATIENT EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

Titanium Gluing Ring Flat Connection

Device

EU MDD · Eu Md Class 2b ·MEDIGMA BIOMEDICAL GMBH·On the market·32 countries

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·SIR-Spheres Y-90 resin microspheres

Oxford Modular Shoulder

FDA registration

CORIN LTD.·1 product·🇬🇧 United Kingdom

Predator Zirconia Diamonds

FDA registration

PRIMA DENTAL GROUP·1 product·🇬🇧 United Kingdom

Rod to Rod Spinal Cross Brace

FDA registration

CORIN LTD.·3 products·🇬🇧 United Kingdom

Trinity-i Acetabular Shells

FDA registration

CORIN LTD.·2 products·🇬🇧 United Kingdom

Olympus GIF-1TQ160

FDA registration

Probo Medical Ltd·2 products·🇬🇧 United Kingdom

GE Discovery MI

FDA registration

Probo Medical Ltd·2 products·🇬🇧 United Kingdom