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

FDA Pre-Market Approval

FDA Class 3 ·ETI-EBK-PLUS

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-CORE-IGMK PLUS ASSAY

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

APPLICATOR BRUSHES PK OF 76

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Ormco Corporation·1 device

MI+BW-Mantel "M"

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Rosa Toifl & Co GmbH·2 devices

Vanillin Pyruvate, Alt/Sgpt

FDA classification

FDA Class 1 ·Vanillin Pyruvate, Alt/Sgpt

Alcohol Control Materials

FDA classification

FDA Class 1 ·Alcohol Control Materials

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA

Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical

FDA classification

FDA Class 1 ·Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Genesis Neurostimulation System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur HBsAgII (HBsII) and ADVIA Centaur HBsAgII Confirmatory (HBsII Conf) Assay

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B e Antigen (HBeAg)

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

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

OFTALMEDICA SRL

Importer

🇮🇹 Italy·13 Manufacturers

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