Acumed Ankle Syndesmosis Repair System

FDA 510(k)

FDA Class 2 ·Orthopedic

FIRST RESPONSE(R) ONE-STEP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VENTREX OXYGEN SENSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SU-POR SURGICAL IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PICC Tip Positioning Aid

FDA 510(k)

FDA Class 2 ·General Hospital

GALILEO Spine Alignment Monitoring System

FDA 510(k)

FDA Class 2 ·Neurology

LANX VBR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ASTRA SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ArcTV Transvaginal Sling System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

ATHEROEDGE

FDA 510(k)

FDA Class 2 ·Radiology

MEDSTREAMING MEDICAL OFFICE SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

ECG CT Gating Device

FDA 510(k)

FDA Class 2 ·Radiology

G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NEURO VENTION LAMINPLASTY PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ZEUS MALE CONDOM APPLICATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ALTUM ANTERIOR CERVICAL PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery