Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Ballon

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL Nu-Knit Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, SUR

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL FIBRILLAR Absorbable Hemostat, SUR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P and Solara Bipolar/Qu

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI/Amplia MRI Quad/Brava/Brava Quad/Claria MRI/Claria MRI Quad/Compia MRI/Concerto II/Consulta/Maximo II/Viva Qu

Scissors, Wire Cutting, Ent, Non-Sterile

FDA classification

FDA Class 1 ·Scissors, Wire Cutting, Ent, Non-Sterile

Staple, Absorbable

FDA classification

FDA Class 2 ·Staple, Absorbable

APPLICATORS ADHESIVE PK 75

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Ormco Corporation·1 device

Polyp Trap

Basic UDI-DI

EU MDR · Eu Md Class 1 ·G-FLEX FLEXIBLE INSTRUMENTS EUROPE·4 devices

KTR Europe GmbH

Authorized representative

🇩🇪 Germany·135 Manufacturers·3461 Devices

Advena Limited

Authorized representative

🇲🇹 Malta·467 Manufacturers·13717 Devices