POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX M150 SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AGE Automatic Wrist Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANTI-WRINKLE (AGING) LIGHT, MODEL AAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NAVIAID BGE DEVICE, MODEL 21-001

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AGE Automatic Wrist Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Gutta Percha Points

FDA registration

SHANGHAI XING YU MEDICAL EQUIPMENT CO., LTD.·1 product·🇨🇳 China

Absorbent Paper Points

FDA registration

SHANGHAI XING YU MEDICAL EQUIPMENT CO., LTD.·1 product·🇨🇳 China

Dental Files

FDA registration

SHANGHAI XING YU MEDICAL EQUIPMENT CO., LTD.·1 product·🇨🇳 China

immunoLINE IgE Inhalation KW3

Device

EU IVDD · Eu Ivd General ·Gold Standard Diagnostics Kassel GmbH·On the market

immunoLINE IgE Nutritional KW2

Device

EU IVDD · Eu Ivd General ·Gold Standard Diagnostics Kassel GmbH·On the market

immunoLINE IgE Nutritional KW1

Device

EU IVDD · Eu Ivd General ·Gold Standard Diagnostics Kassel GmbH·On the market

IgE Rapid Test Device

Device

EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·On the market

IgE Rapid Quantitative Test

Device

EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·On the market

Total Immunoglobulin E (IgE)

Device

EU IVDR · Eu Ivd Class B ·Beckman Coulter Inc.·On the market·32 countries

Quantia Ferritin/Myoglobin/IgE Control (LN 6K56-21, 6K56-22)

FDA registration

ABBOTT LABORATORIES·3 products·🇺🇸 United States

NOVEOS™ Specific IgE (sIgE) Assay Capture Reagent – M006, Alternaria alternata

FDA registration

HYCOR BIOMEDICAL·1 product·🇺🇸 United States