22 results · 48ms · Sources: EU EUDAMED, US FDA

Calibrator Glycosylated Hemoglobin

FDA registration
BIONOSTICS, INC.·1 product·🇺🇸 United States

S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023

FDA 510(k)
FDA Class 2 ·Hematology

ZIMMER PTE. LTD.

FDA registration
ZIMMER PTE. LTD.·1 product·🇸🇬 Singapore

MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM

FDA registration
BIOMET, INC.·1 product·🇺🇸 United States

Zimmer (Shanghai) Medical International Trading Co., Ltd.

FDA registration
Zimmer (Shanghai) Medical International Trading Co., Ltd.·1 product·🇨🇳 China

Zimmer Biomet Pty Ltd

FDA registration
Zimmer Biomet Pty Ltd·1 product·🇦🇺 Australia

Schneider ASR B.V.

FDA registration
Schneider ASR B.V.·1 product·🇳🇱 Netherlands

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450053324·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450306611·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450572108·

Assay, Glycosylated Hemoglobin

FDA classification
FDA Class 2 ·Assay, Glycosylated Hemoglobin

SANICURE BV

FDA registration
SANICURE BV·1 product·🇳🇱 Netherlands

ASCA-CHEK

FDA registration
TECHLAB, INC.·1 product·🇺🇸 United States

ASCA-CHEK

FDA registration
TECHLAB, INC.·1 product·🇺🇸 United States

WORLDWIDE SUPPLIES LIMITED

FDA registration
WORLDWIDE SUPPLIES LIMITED·1 product·🇭🇰 Hong Kong

GLOBALMED INTERNATIONAL LTD

FDA registration
GLOBALMED INTERNATIONAL LTD·1 product·🇭🇰 Hong Kong

D3 Ultra Duet DFA Respiratory Virus

FDA registration
Ortho-Clinical Diagnostics, Inc.·5 products·🇺🇸 United States

MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1

FDA 510(k)
FDA Class 2 ·Radiology

General Instrument

FDA UDI
ALPHATEC SPINE, INC.·00840180507513·Curette, Teardrop, Angled, Straight, Smooth, Si...