MODIFICATION TO PLEXOLONG SETS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Diamondback 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9

FDA 510(k)

FDA Class 2 ·Radiology

NovaBone IRM

FDA 510(k)

FDA Class 2 ·Orthopedic

CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23

FDA 510(k)

FDA Class 2 ·Radiology

CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)

FDA 510(k)

FDA Class 2 ·Orthopedic

ControlRad Select Model Z

FDA 510(k)

FDA Class 2 ·Radiology

Sensus TPS Workstation

FDA 510(k)

FDA Class 2 ·Radiology

POLARUS CONNECT

FDA 510(k)

FDA Class 2 ·Orthopedic

Sensus IORT System

FDA 510(k)

FDA Class 2 ·Radiology

iTEAR Neurostimulator

FDA 510(k)

FDA Class 2 ·Ophthalmic

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMNISCREEN HOME DETECTION LINER KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CLEAR (TM) SPECIAL NIT COMB

FDA 510(k)

FDA Class 1 ·General Hospital

Acumed Small Fragment Base Set

FDA 510(k)

FDA Class 2 ·Orthopedic

ACUMED CONGRUENT BONE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ViperCath XC Peripheral Exchange Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MONOSTAR SYSTEM: IM LATEX TEST

FDA 510(k)

FDA Class 2 ·Immunology