Astute Drill Bit Q.C. Dia. 4.0mm, Length 225mm (for Astute Hip Fracture Nail Instrument Set)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Narang Medical Limited·1 device

Ellecom GmbH

Authorized representative

🇩🇪 Germany·11 Manufacturers·11 Devices

LORCAN & FYON B.V.

Authorized representative

🇳🇱 Netherlands·21 Manufacturers·37 Devices

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·RAPID FFN FOR THE TLI SYSTEM

Access SARS-CoV-2 IgG (1st IS) QC

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

Sarns™ Modular Perfusion System 8000

FDA UDI

Terumo Cardiovascular Systems Corporation·00886799000212·Cardioplegia Monitor

Sarns™ Modular Perfusion System 8000

FDA UDI

Terumo Cardiovascular Systems Corporation·00886799001721·Lamp Long 33"

Sarns™ Modular Perfusion System 8000

FDA UDI

Terumo Cardiovascular Systems Corporation·00886799000229·CDI 500 Comm module for TCVS Sarns 8000

Sarns™ Modular Perfusion System 8000

FDA UDI

Terumo Cardiovascular Systems Corporation·00886799000342·Flow meter

Sarns™ Modular Perfusion System 8000

FDA UDI

Terumo Cardiovascular Systems Corporation·00886799000236·Line Occluder

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATH TEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PHUR-CA)

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THXID BRAF KIT

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD FOCALPOINT GS IMAGING SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)