189 results · 32ms · Sources: EU EUDAMED, US FDA

Aptima Combo 2 Assay (Panther System)

FDA 510(k)
FDA Class 2 ·Microbiology

MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER

FDA 510(k)
FDA Class 2 ·Radiology

Eviva Stereotactic Guided Breast Biopsy System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FS IV MINI C-ARM SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Panther Fusion AdV/hMPV/RV Assay

FDA 510(k)
FDA Class 2 ·Microbiology

TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001

FDA 510(k)
FDA Class 2 ·Radiology

QUANTRA

FDA 510(k)
FDA Class 2 ·Radiology

INVADER FACTOR II

FDA 510(k)
FDA Class 2 ·Hematology

MULTIVIEW

FDA 510(k)
FDA Class 2 ·Radiology

SECRMARK BIOPSY SITE MARKING SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Aptima BV Assay; Aptima CV/TV Assay

FDA 510(k)
FDA Class 2 ·Microbiology

MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)

FDA 510(k)
FDA Class 2 ·Radiology

MODIFIED QDR-1000 X-RAY BONE DENSITOMETER

FDA 510(k)
FDA Class 2 ·Radiology

Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

FDA 510(k)
FDA Class 2 ·Microbiology

Genius AI Detection 2.0

FDA 510(k)
FDA Class 2 ·Radiology

ProFlu+ Assay

FDA 510(k)
FDA Class 2 ·Microbiology

Panther Fusion AdV/hMPV/RV Assay

FDA 510(k)
FDA Class 2 ·Microbiology

Aptima Trichomonas vaginalis Assay

FDA 510(k)
FDA Class 2 ·Immunology