Champion

FDA registration

AIRWAY SURGICAL APPLIANCES LTD.·1 product·🇨🇦 Canada

Gener-8

FDA registration

FOR YOU, INC.·1 product·🇺🇸 United States

Diagnostic Kit for Immunoglobulin E(IgE) (Fluorescent Immunnochromatographic Assay)

FDA registration

Hangzhou Sightnovo Medical Technology Co., Ltd.·1 product·🇨🇳 China

Datex-Ohmeda Inc.

Manufacturer

🇺🇸 United States·74 Basic UDI-DIs·114 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EXALIS, SOFTWARE VERSION 1.15

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOLECULAR ADSORBENT RECIRCULATING(MARS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COMPUTER DYNO/GONIO/MYO GRAPHY

FDA 510(k)

FDA Class 2 ·Physical Medicine

MEGATEX PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

PHOENIX HEMODIALYSIS DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX SYSTEM 7.10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUNDT-KEES REINFORCING ANEURYSM CLIP

FDA 510(k)

FDA Class 2 ·Neurology