TDS (TECHWIN DENTAL SYSTEM)

FDA 510(k)

FDA Class 2 ·Dental

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL BIOPROSTHESIS, MODEL 7000 AND 7000TFX

Diode Laser Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intensity Pulsed Light Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETER, XTRA SURGICAL CRYOABLATION CATHETER, MAX SURGICAL CARDIAC CRYOABLATION CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CRYOABLATION DEVICE

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PULSAR, PULSAR MAX, DISCOVER, INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO FAMILIES OF PACEMAKER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICE, FREEZOR MAX SURGICAL CRYOABLATION DEVICE

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CRYOABLATION CATHETERS, FREEZOR XTRA SURGICAL CRYOABLATION DEVICES, FREEZOR MAX SURGICAL CRYOABLATION DEVICES,

Amplifon

FDA UDI

Ws Audiology Usa, Inc.·05714880166309·ampli-energy R 3 AX R-D SnowWhite RoseGold

Amplifon

FDA UDI

Ws Audiology Usa, Inc.·05714880166378·ampli-energy R 3 AX R-D Black Silver

Amplifon

FDA UDI

Ws Audiology Usa, Inc.·05714880166293·ampli-energ R 3 AX R-D SnowWhite SnowWhite Gloss

Amplifon

FDA UDI

Ws Audiology Usa, Inc.·05714880166354·ampli-energy R 3 AX R-D Black Black Gloss

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Epic™ Plus Tissue Heart Valves, Epic™ Max Tissue Heart Valves, Epic™ Tissue Heart Valves

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR CARDIAC CRYOABLATION CATHETER /XTRA SUGICAL/ MAX SURGICAL CARDIA CRYOABLATION DEVICES, STERILE ACCESSORIES COAX

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Freezor Cardiac Cryoablation Catheter; Freezor Xtra Surgical Cardiac Cryoablation Device; Freezor MAX Cardiac Cryoablati

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Freezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Cath