iTind System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

iTind System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

FDA classification

FDA Class 2 ·Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

T1040 AKA AURAWAVE

FDA 510(k)

FDA Class 2 ·Neurology

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG

MULTI-PRIME AKA/MONO-PRIME

FDA 510(k)

FDA Class 2 ·Dental

PARA CHECK (AKA EIGHT CHECK-C)

FDA 510(k)

FDA Class 2 ·Hematology

BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743)

FDA 510(k)

FDA Class 2 ·Radiology

CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

FDA 510(k)

FDA Class 2 ·Orthopedic

Inspire ICE aka Inspire ICE Clear Brackets

FDA 510(k)

FDA Class 2 ·Dental

BK-A; BK-B; BK-IS SEALING CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)

FDA 510(k)

FDA Class 2 ·Anesthesiology

COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

VORTECH'S FILM DIGITIZER, FD-1

FDA 510(k)

FDA Class 2 ·Radiology

SMPLE PLATE AND SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOMET FORERUNNER LOCKING PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MAC MALE ADAPTER

FDA 510(k)

FDA Class 2 ·Orthopedic