Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY TFC DEVICE WITH INSTRUMENTATION

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION

Thin Layer Chromatography, Phenobarbital

FDA classification

FDA Class 2 ·Thin Layer Chromatography, Phenobarbital

Bromcresol Green Dye-Binding, Albumin

FDA classification

FDA Class 2 ·Bromcresol Green Dye-Binding, Albumin

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA classification

FDA Class 2 ·Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Ventilator, Continuous, Minimal Ventilatory Support, Home Use

FDA classification

FDA Class 2 ·Ventilator, Continuous, Minimal Ventilatory Support, Home Use

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

FDA classification

FDA Class 2 ·Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Implant, Endosseous, Orthodontic

FDA classification

FDA Class 2 ·Implant, Endosseous, Orthodontic

Digital Pathology Image Viewing And Management Software

FDA classification

FDA Class 2 ·Digital Pathology Image Viewing And Management Software

Control Material, Blood Circulating Epithelial Cancer Cell

FDA classification

FDA Class 2 ·Control Material, Blood Circulating Epithelial Cancer Cell

Cervical Intraepithelial Neoplasia (Cin) Test System

FDA classification

FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System

Automated Digital Image Manual Interpretation Microscope

FDA classification

FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope

BIOPRO POLAR HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

ACUTE CARDIAC CARE SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMOKE EATER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMNISOUND THERAPY UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

ESCOTEK EST 220 INTERFERENCE THERAPY UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

TNS MK I STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

SYBRON/KERR MIRROR 3

FDA 510(k)

FDA Class 2 ·Dental

FRANCIS NASAL TUBE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery