PEDIATRIC INGESTASCAN

FDA 510(k)

FDA Class 2 ·Ophthalmic

MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPINEMED

FDA 510(k)

FDA Class 2 ·Physical Medicine

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R)SOLITAIRE(TM) BALL.DIL.CATH.W/PRO/PEL(TM)

ACTOnco, ACTOnco IVD

FDA 510(k)

FDA Class 2 ·Pathology

NightOwl

FDA 510(k)

FDA Class 2 ·Anesthesiology

NightOwl

FDA 510(k)

FDA Class 2 ·Anesthesiology

TD-7301 Spirometer (TD-7301)

FDA 510(k)

FDA Class 2 ·Anesthesiology

TD-7301 Peak Flow meter

FDA 510(k)

FDA Class 2 ·Anesthesiology

TD-5010 Lancing Device and TD-5084 Sterile Lancets

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NightOwl

FDA 510(k)

FDA Class 2 ·Anesthesiology

INNOVASA STAT*SEAL TOPICAL HEMOSTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAR Apollo™ Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYNAMESH -CICAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL

SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit

FDA 510(k)

FDA Class 2 ·Neurology

Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit

FDA 510(k)

FDA Class 2 ·Neurology

First Relief

FDA 510(k)

FDA Class 2 ·Neurology

Primary Relief

FDA 510(k)

FDA Class 2 ·Neurology