100 results · 41ms · Sources: EU EUDAMED, US FDA

MODIFIED DR-2C/PMC 100

FDA 510(k)
FDA Class 2 ·Cardiovascular

GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300

FDA 510(k)
FDA Class 2 ·Cardiovascular

EIM-107 PREP-CHECK

FDA 510(k)
FDA Class 2 ·Neurology

GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)

FDA 510(k)
FDA Class 2 ·Cardiovascular

GEMSCOM SERIES 3000

FDA 510(k)
FDA Class 2 ·Cardiovascular

EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)

FDA 510(k)
FDA Class 2 ·Cardiovascular

ROSETTA-LT/ROSETTA-RX

FDA 510(k)
FDA Class 2 ·Cardiovascular

PREP-CHECK

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRU-VIEW MULTI-CHANNEL DISPLAY

FDA 510(k)
FDA Class 2 ·Cardiovascular

GEMSCOM SERIES 5000,

FDA 510(k)
FDA Class 2 ·Cardiovascular

DR-2C

FDA 510(k)
FDA Class 2 ·Cardiovascular

ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE

FDA 510(k)
FDA Class 2 ·Physical Medicine

IMAGING JET SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

ACS:CENTAUR AFP

FDA 510(k)
FDA Class 2 ·Immunology

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval
FDA Class 2 ·PRONOVA ABSORABLE SUTURE, USP

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

Device, General Purpose, Hematology

FDA classification
FDA Class 2 ·Device, General Purpose, Hematology

Powered Light Based Non-Laser Surgical Instrument

FDA classification
FDA Class 2 ·Powered Light Based Non-Laser Surgical Instrument

Powered Laser Surgical Instrument

FDA classification
FDA Class 2 ·Powered Laser Surgical Instrument

Powered Laser Surgical Instrument With MicrobeamFractional Output

FDA classification
FDA Class 2 ·Powered Laser Surgical Instrument With MicrobeamFractional Output