dermaPACE System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CYGNUS™ MoRe Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

OPTISTRAND, MODEL 1032S

FDA 510(k)

FDA Class 2 ·Radiology

STONE EXTRACTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ablatherm Fusion

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EZ SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Asept Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUTOJECT 2

FDA 510(k)

FDA Class 2 ·General Hospital

NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.

FDA 510(k)

FDA Class 2 ·Neurology

UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER

FDA 510(k)

FDA Class 2 ·Neurology

Physiotrace

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Endoform Reconstructive Template

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ZEPTO Precision Capsulotomy System

FDA 510(k)

FDA Class 2 ·Ophthalmic

RRIANGLE KNIFE

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)

FDA 510(k)

FDA Class 2 ·General Hospital

Europa Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Austin Miller Large External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

IO Expandable Lumbar Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic