Multi-Unit DAS System

FDA 510(k)

FDA Class 2 ·Dental

I-Motion

FDA 510(k)

FDA Class 2 ·Physical Medicine

Nuubo Smart

FDA 510(k)

FDA Class 2 ·Cardiovascular

COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls

FDA 510(k)

FDA Class 2 ·Microbiology

BTI Interna Prosthetic Components

FDA 510(k)

FDA Class 2 ·Dental

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

FDA 510(k)

FDA Class 2 ·General Hospital

RHEUMAGEN RF T-CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

PhoeniX

FDA 510(k)

FDA Class 2 ·Radiology

Cohitech Cottonlock Tampons with Reusable Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GEM HEART ONE/ONE+

FDA 510(k)

FDA Class 2 ·Cardiovascular

IPD Dental Implant Abutments

FDA 510(k)

FDA Class 2 ·Dental

GMI Frontier Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Reverso Pro System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

3D-SHAPER

FDA 510(k)

FDA Class 2 ·Radiology

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DEFCON TSA/TSH DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

RHEUMAJET RF

FDA 510(k)

FDA Class 2 ·Immunology

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology