TENS CARE, MODEL XL-Y3

FDA 510(k)

FDA Class 2 ·Neurology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Artus CMV RGQ and QS-RGQ MDx Kit

MEMO 4D

FDA 510(k)

FDA Class 2 ·Cardiovascular

Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEMO 3D ReChord

FDA 510(k)

FDA Class 2 ·Cardiovascular

EZ-IO INTRAOSSEOUS INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307

FDA 510(k)

FDA Class 2 ·Immunology

ADVIA Centaur Herpes-1 IgG

FDA 510(k)

FDA Class 2 ·Microbiology

PACS CORE/ENCORE

FDA 510(k)

FDA Class 2 ·Radiology

LP(A) CALIBRATORS, AND LP(A) CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur Herpes-2 IgG

FDA 510(k)

FDA Class 2 ·Microbiology

ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARCHITECT IVANCOMYCIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·artus CMV RGQ MDx Kit and artus CMV QS-RGQ MDx Kit

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit

COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology