Acid Hematin

FDA classification

FDA Class 2 ·Acid Hematin

THD

FDA 510(k)

FDA Class 2 ·Radiology

FastStroke

FDA 510(k)

FDA Class 2 ·Radiology

URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43R HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·TRI POL 43 CONTACT LENS

CURIETRON 192 LOW DOSE RATE

FDA 510(k)

FDA Class 2 ·Radiology

EMMA 1.5T MRI System

FDA 510(k)

FDA Class 2 ·Radiology

HTS EXTREMITY COIL, HTS SURFACE COIL

FDA 510(k)

FDA Class 2 ·Radiology

MONICA IF24

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)

FDA 510(k)

FDA Class 2 ·Orthopedic

MONICA AN24

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)

FDA 510(k)

FDA Class 2 ·Orthopedic

TRIPORE, MODELS HA, BP90, BP15

FDA 510(k)

FDA Class 2 ·Orthopedic

si-Mochi

FDA 510(k)

FDA Class 2 ·Orthopedic

MONICA NOVII WIRELESS PATCH SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology