Wuhan J.H. Bio-Tech Co., Ltd.

Manufacturer

🇨🇳 China·7 Basic UDI-DIs·7 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

YASEE BioMedical Inc.

Manufacturer

🇨🇳 China·2 Basic UDI-DIs·2 Devices·1 Importer·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

BOMEI Co.,Ltd

Manufacturer

🇹🇼 Taiwan·291 Basic UDI-DIs·352 Devices·SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, SGS Belgium NV, and SGS Belgium NV

SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER

FDA 510(k)

FDA Class 2 ·General Hospital

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NaviStar Catheter, NaviStar RMT Catheter, EZ Steer Nav Catheter, Interface Cables

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS THERMOCOOL, THERMOCOOL SF, NAVISTAR THERMOCOOL, THERMOCOOL SF NAV, THERMOCOOL SMARTTOUCH

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS/NAVISTAR RMT DS/EZ STEER NAV DS/QWIKSTAR DS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR ,NAVISTAR RMT ,EZ STEER NAV CATHETERS AND,BIOSENSE WEBSTER CABLES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL AND EZ STEER THERMOCOOL NAV DIAGNOSTIC/ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL//NAVISTAR RMT//EZ STEER/EZ STEER THERMOCOOL NAV CATHETERS

OmnisEMG

FDA registration

ACCELERATED CARE PLUS CORP.·1 product·🇺🇸 United States

ANSELL HEALTHCARE PRODUCTS LLC

FDA registration

ANSELL HEALTHCARE PRODUCTS LLC·1 product·🇺🇸 United States

ANSELL HEALTHCARE PRODUCTS LLC

FDA registration

ANSELL HEALTHCARE PRODUCTS LLC·1 product·🇺🇸 United States

ANSELL HEALTHCARE PRODUCTS LLC

FDA registration

ANSELL HEALTHCARE PRODUCTS LLC·1 product·🇺🇸 United States

INNOVATIVE INNOVATIONS INC.

FDA registration

INNOVATIVE INNOVATIONS INC.·1 product·🇺🇸 United States

Melzi Sharps Finder

FDA registration

MELZI CORPORATION·1 product·🇺🇸 United States

thePulsystem

FDA registration

PUL & Co.·1 product·🇺🇸 United States

SOURCEWAVE LLC

FDA registration

SOURCEWAVE LLC·1 product·🇺🇸 United States

Vario Loupes

FDA registration

LUMADENT INC·1 product·🇺🇸 United States