PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL

FDA 510(k)

FDA Class 1 ·General Hospital

ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS

FDA 510(k)

FDA Class 2 ·General Hospital

ELECTROMEDICARIN 900

FDA 510(k)

FDA Class 2 ·Physical Medicine

ENDOXANE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FESAN SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

ADVIA Centaur EBV-EBNA IgG

FDA 510(k)

FDA Class 1 ·Microbiology

NEWDEAL K WIRE

FDA 510(k)

FDA Class 2 ·Orthopedic

DeepRhythm Platform

FDA 510(k)

FDA Class 2 ·Cardiovascular

COVAMESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROSA ONE Spine application

FDA 510(k)

FDA Class 2 ·Neurology

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

KALIX II IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

LAPIDUS PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

ROSA BRAIN (v3.0.0.5)

FDA 510(k)

FDA Class 2 ·Neurology

L-VARLOCK

FDA 510(k)

FDA Class 2 ·Orthopedic

POIRIER COMMODES

FDA 510(k)

ENDOBOY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

M3 MICROKERATOME

FDA 510(k)

FDA Class 1 ·Ophthalmic

ADVIA Centaur Herpes-2 IgG

FDA 510(k)

FDA Class 2 ·Microbiology