NavaClick Injection System

FDA 510(k)

FDA Class 2 ·General Hospital

DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40

FDA 510(k)

FDA Class 2 ·Cardiovascular

Synchrony (20-3000)

FDA 510(k)

FDA Class 2 ·Neurology

HAMMERLOCK

FDA 510(k)

FDA Class 2 ·Orthopedic

RPM Reinforced PTFE Mesh

FDA 510(k)

FDA Class 2 ·Dental

JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC

FDA 510(k)

FDA Class 2 ·Orthopedic

Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle

FDA 510(k)

FDA Class 2 ·Cardiovascular

TANTALUM BEAD SET, MODEL P003175

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IRRIGATOR/ASPIRATOR PROBE

FDA 510(k)

FDA Class 1 ·Ophthalmic

THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Anexa Wound Flush, Sterile Water & Sterile Normal Saline

FDA 510(k)

FDA Unclassified ·Unknown

ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE

FDA 510(k)

FDA Class 1 ·General Hospital

MiroDry Wound Matrix

FDA 510(k)

FDA Unclassified ·Unknown

SUTTER CPM

FDA 510(k)

FDA Class 1 ·Physical Medicine

MEDLITE/ERBIUM LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BASELINE CALIBRATION VERIFICATION CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30

FDA 510(k)

FDA Class 2 ·Clinical Chemistry