570 results · 23ms · Sources: EU EUDAMED, US FDA

Elecsys TSH

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Elecsys Tg II

FDA 510(k)
FDA Class 2 ·Immunology

ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE

FDA 510(k)
FDA Class 2 ·Radiology

EBI OMEGA21 SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SOLITAIRE-C CERVICAL SPACER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EBI ESL SPINE SPACER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EBI ACUMEN SURGICAL NAVIGATION SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

MODIFICATION TO EBI SPINELINK SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EBI XFIX DFS SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO OMEGA 21 SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EBI XFIX DFS SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EBI P148 SPINAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EBI ARRAY SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic