Bausch & Lomb Incorporated

FDA registration

Bausch & Lomb Incorporated·3 products·🇺🇸 United States

Eko Analysis Software

FDA registration

Eko Health, Inc.·3 products·🇺🇸 United States

Eko Analysis Software

FDA UDI

Eko Devices, Inc.·00850010298030·The Eko Analysis Software is intended to provid...

DETER. OF PHOSPHOHEXOSE ISOMERASE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

AD00xWD(L)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·ADRANOX SRL·6 devices

Surgical Gowns

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Sichuan Shuzhan New Materials Co., Ltd·1 device

RX daytona plus (with ISE)

FDA registration

RANDOX LABORATORIES LIMITED·5 products·🇬🇧 United Kingdom

LACT Gen.2, 225Tests, cobas c 701

FDA registration

ROCHE DIAGNOSTICS GMBH·5 products·🇩🇪 Germany

RX daytona plus (with ISE)

FDA registration

RANDOX LABORATORIES LIMITED·5 products·🇬🇧 United Kingdom

RX daytona plus (with ISE)

FDA registration

Randox Teoranta·5 products·🇮🇪 Ireland

Synermed IR500 Chemistry Analyzer IVD

FDA registration

Infrared Laboratory Systems dba SYNERMED·11 products·🇺🇸 United States

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ARCHITECT AFP ASSAY

LIQUID ALT(SGPT) REAGENT SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PYRIDOXAL-5-PHOSPHATE STRIPES

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ASPARTATE AMINOTRANSFERASE (AST) TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DATA-ZYME AST(GOT) PROCEDURE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALT S.C.E. (GPT)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LACTATE DEHYDROGENASE REAGENT SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry