2,650 results · 80ms · Sources: EU EUDAMED, US FDA

Analyzer

FDA registration
Diamond Diagnostics Inc.·9 products·🇭🇺 Hungary

H ISE REFERENCE ELECTRODE

FDA registration
ROCHE DIAGNOSTICS GMBH·9 products·🇩🇪 Germany

ISL QC 2000

FDA 510(k)
FDA Class 2 ·Ophthalmic

PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.

FDA 510(k)
FDA Class 2 ·Ophthalmic

MICRORUPTER V

FDA 510(k)
FDA Class 2 ·Ophthalmic

NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS

FDA 510(k)
FDA Class 2 ·Ophthalmic

NIDEK MODEL YC-1200

FDA 510(k)
FDA Class 2 ·Ophthalmic

MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP

FDA 510(k)
FDA Class 2 ·Ophthalmic

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MemoryGel Silicone Gel-Filled Breast Implants

ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

α-Amylase Kit (CNPG3 Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

α-Amylase Kit (IFCC Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

AED Endoscopes

FDA registration
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·1 product·🇺🇸 United States

ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Amylase Reagent (AMY7 2 x 200)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

α-Amylase Assay Kit (EPS Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Da Te Bioengineering Technology Co., LTD.·1 device

α-Amylase Assay Kit (EPS Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Da Te Bioengineering Technology Co., LTD.·1 device

α-Amylase Assay Kit (EPS Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Da Te Bioengineering Technology Co., LTD.·1 device

α-Amylase Assay Kit (EPS Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Da Te Bioengineering Technology Co., LTD.·1 device

α-Amylase Assay Kit (EPS Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Da Te Bioengineering Technology Co., LTD.·1 device