2,003 results · 42ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·QUADRA ASSURA/UNIFY ASSURA FAMILY PF CRT-DS

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

FDA Pre-Market Approval
FDA Class 3 ·INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter

Fractional CO2 Laser Machine

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Medical Picosecond ND: YAG Laser System (PZ-6)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Diode laser hair removal device

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Muscle Stimulator Device (PZ-100)

FDA 510(k)
FDA Class 2 ·Physical Medicine

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

FDA Pre-Market Approval
FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER

Malaria P.f Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

CHAMP Malaria P.f Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·KH Medical Co., Ltd.·1 device

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters

NA

FDA UDI
DOMICO MED-DEVICE, LLC·00810050241120·CHILD IMMOBILIZER

NA

FDA UDI
DOMICO MED-DEVICE, LLC·00810050241618·PEDIATRIC IMMOBILIZER

Malaria P.f. Rapid Test Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

Malaria P.f/Pan Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Assure Tech. (Hangzhou) Co., Ltd.·1 device

Malaria P.f Antigen Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

Malaria P.f P.v Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sejoy Biomedical Co., Ltd.·1 device

Malaria P.f Pan Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sejoy Biomedical Co., Ltd.·1 device

Malaria P.f. Rapid Test Device

Basic UDI-DI
EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·1 device