Sim&Size

FDA 510(k)

FDA Class 2 ·Radiology

Ankyras

FDA 510(k)

FDA Class 2 ·Radiology

SpringTMS

FDA 510(k)

FDA Class 2 ·Neurology

Nerivio; NerivioInfinity

FDA 510(k)

FDA Class 2 ·Neurology

Eroxon

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BAYER PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ACTIVE PSA ELISA (DSL-10-9700)

FDA 510(k)

FDA Class 2 ·Immunology

SculpSure

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diosculpt

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

SculpSure

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

MEDLINE ANTI-EMBOLISM STOCKING

FDA 510(k)

FDA Class 2 ·General Hospital

OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS

FDA 510(k)

FDA Class 2 ·General Hospital

OrthoGold

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery