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

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA classification
FDA Class 2 ·Full Field Digital, System, X-Ray, Mammographic

MIE SCINTRON GAMMA CAMERA SYSTEMS

FDA 510(k)
FDA Class 2 ·Radiology

ECAT SCINTRON PET

FDA 510(k)
FDA Class 2 ·Radiology

MODIFICATION TO SCINTRON IV

FDA 510(k)
FDA Class 2 ·Radiology

GMI Frontier Dental Implant System

FDA 510(k)
FDA Class 2 ·Dental

SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20

FDA 510(k)
FDA Class 2 ·General Hospital

Cue COVID-19 Molecular Test

FDA 510(k)
FDA Class 2 ·Microbiology

Cue COVID-19 Molecular Test

FDA 510(k)
FDA Class 2 ·Microbiology

MIE - GAMMA CAMERA SYSTEMS

FDA 510(k)
FDA Class 2 ·Radiology

CUE AMBULATORY VOLUMETRIC INFUSION PUMP

FDA 510(k)
FDA Class 2 ·General Hospital

WELCON HUE-VU URINARY DRAINAGE BAG

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

TITANIUM M.E. MULLER TYPE TOTAL HIP

FDA 510(k)
FDA Class 2 ·Orthopedic

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)

FDA 510(k)
FDA Class 2 ·Ophthalmic

AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES

FDA 510(k)
FDA Class 2 ·Anesthesiology

REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES

FDA 510(k)
FDA Class 2 ·General Hospital

AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904

FDA 510(k)
FDA Class 2 ·Anesthesiology

AUTOWAND(TM) 7XXX SERIES

FDA 510(k)
FDA Class 2 ·Anesthesiology

NM-01/CPT neurometer (NM-01/CPT)

FDA 510(k)
FDA Class 2 ·Neurology