TOHP-CAP

FDA 510(k)

FDA Class 2 ·General Hospital

NewPrim System

FDA 510(k)

FDA Class 2 ·Orthopedic

BRM TOOL Screws, BIOPLAN Subtalar Implant

FDA 510(k)

FDA Class 2 ·Orthopedic

BRM Digitalis Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

BRM TOOL Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401

FDA 510(k)

FDA Class 2 ·Radiology

LOBSTER AUTO-INJECTOR

FDA 510(k)

FDA Class 2 ·General Hospital

IMAGYN 125 I SEED, MODEL IS 125

FDA 510(k)

FDA Class 2 ·Radiology

WHISPERJECT AUTOINJECTOR

FDA 510(k)

FDA Class 2 ·General Hospital

PYTON

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ValvuloPro Valvuloplasty Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ValvuloPro Valvuloplasty Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);

FDA 510(k)

FDA Class 2 ·Cardiovascular

HOFFMAN IVF-1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRANSPORTABLE MODEL STS-T LITHOTRIPTER

TrainFES Advance

FDA 510(k)

FDA Class 2 ·Physical Medicine