Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SECURA & MAXIMO II ICDS

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·WRAPSODY® Cell-Impermeable Endoprosthesis

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

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CONSULTA & MAXIMO ICDS

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIOMET EBI BONE HEALING SYSTEM

SURGICAL ADHESIVE TAPE

FDA 510(k)

FDA Class 1 ·General Hospital

Atlas™ Humeral Nail System

FDA 510(k)

FDA Class 2 ·Orthopedic

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G4 PLATINUM RECEIVER, G4 PLATINUM PEDIATRIC RECEIVER, DEXCOM G5 MOBILE RECEIVER, DEXCOM G4 PLATINUM RECEIVER WIT

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·QCELLUS LASER

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 Dual ISH DNA Probe Cocktail assays

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ITREL SPINAL CORD STIMULATION SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER IOL'S

Merz Aesthetics GmbH

Authorized representative

🇩🇪 Germany·3 Manufacturers

Merz Pharmaceuticals GmbH

Authorized representative

🇩🇪 Germany·3 Manufacturers

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·THERMA CHOICE UTERINE BALLOON THERAPY SYSTEM

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Merz Pharmaceuticals GmbH

Importer

🇩🇪 Germany·3 Manufacturers

Villa Manus Oy

Importer

🇫🇮 Finland·2 Manufacturers

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems