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

FDA Pre-Market Approval

FDA Class 3 ·Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non

HAV IgM Rapid Test Cassette (Serum/Plasma)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhejiang Orient Gene Biotech Co., Ltd·1 device

Rapid HAV IgG/IgM Combo Test Card

Basic UDI-DI

EU IVDD · Eu Ivd General ·Xiamen Boson Biotech Co., Ltd.·1 device

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

FDA Pre-Market Approval

FDA Class 3 ·Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT

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

FDA Pre-Market Approval

FDA Class 3 ·Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT

CINA-VCF

FDA 510(k)

FDA Class 2 ·Radiology

CINA-ASPECTS

FDA 510(k)

FDA Class 2 ·Radiology

CINA-iPE

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer Navigational 4mm; C3 EZ Steer Thermocool Nav; Ez Steer Thermocool Non-Navigational 4mm (TC); EZ Steer Thermocoo

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

FDA Pre-Market Approval

FDA Class 3 ·Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, and Biosens

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

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER

Diagnostic kit for anti-HAV IgM( Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Nantong EgensBiotechnology Co.,Ltd.·1 device

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx

NAV Medical s.r.o.

Importer

🇨🇿 Czechia

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

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D-1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·BIOSENSE WEBSTER CABLES, CELSIUS DS CATHETER, CELSIUS FLTR, EZ STEER NAV DS CATH, NAVISTAR DS CATH, NAVISTAR RMT DS CATH

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

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER

LIA-ANA-Profile

Basic UDI-DI

EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·1 device