DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

X-FLO Fluid Management System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HYSTEROMED 100

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FluidSmart

FDA registration

COMMAND MEDICAL NICARAGUA SA·3 products·🇳🇮 Nicaragua

Thermaclear

FDA registration

Sterigenics Costa Rica S.R.L.·3 products·🇨🇷 Costa Rica

LL0004 - Tubing Set – Single Lumen Inflow with Dual Outflow

FDA registration

THERMEDX, LLC·3 products·🇺🇸 United States

0502-500-001 ThermaClear Main Module

FDA registration

STRYKER ENDOSCOPY·3 products·🇺🇸 United States

Thermedx7581 (PL) - Luer Lock Set, Single Lumen

FDA registration

Isomedix Operations Inc.·3 products·🇺🇸 United States

0502-500-001 ThermaClear Main Module

FDA registration

STRYKER Communications, Inc.·3 products·🇺🇸 United States

P2000 FluidSmart Fluid Management system (at the time of clearance, this was called “Thermedx Fluid Management System”

FDA registration

THERMEDX, LLC·3 products·🇺🇸 United States

FluidSmart

FDA registration

Excel Medical Products, Inc.·3 products·🇺🇸 United States

FluidSmart

FDA registration

Sterigenics Costa Rica S.R.L.·3 products·🇨🇷 Costa Rica

Fluid Management System

FDA UDI

THERMEDX, LLC·00860936000327·

Luer Lock Set, Single Lumen

FDA UDI

THERMEDX, LLC·00860936000334·

Aveta Auto 5 Fr Disposable Resecting Device

FDA UDI

MEDITRINA, INC.·00850006759668·Aveta Auto 5 Fr Disposable Resecting Device for...

High Pressure Luer Lock Set, Single Lumen 300mmHg

FDA UDI

THERMEDX, LLC·00860936000341·

Urology Set

FDA UDI

THERMEDX, LLC·00860936000365·Urology Set