Smith Associates’ history over 23 years with CDRH and CBER Divisions of the FDA has been extremely productive for our clients. Below is an overview by Branch of the many projects we have either completed or are currently under review.

Cardiovascular Branch

Cardiac Imaging Systems

Arterial Hardness and Blood Pressure

Monitors (OTC)

Patient Monitoring Systems

Patient Simulator

Digital Blood Pressure Monitor (OTC)

Wrist Digital Blood Pressure Monitor (OTC)

Non-Invasive Blood Pressure Monitor with Printer (OTC)

Ultrasonic transducer

Cardiac Monitor

Multi-Parameter Patient Monitoring System

3 Parameter Patient Monitoring System

Noninvasive Blood Pressure Measurement System

Noninvasive Blood Pressure Monitor

General Hospital Branch

Forehead Thermometer (OTC)

Tympanic Thermometer (OTC)

Instant Fever Thermometer (OTC)

Clinical Thermometers (OTC)

Acupuncture Needles

Silver Acupuncture Needles

I.V. Pump Tester

Fluid Warmer

Warming Cabinets

Controlled Temperature Warming Cabinets

Huber Safety Needles

Sterilization Pouches

Blood Collection Tube Holder

Liberator Powered Wheelchair with Solar Companion

Mechanical Wheelchair

Ostomi-i Alert

Scalp Vein Set

Blood Glucose Dosing Calculator

Clinical Electronic Thermometer

Self-seal Sterilzation Pouch

Huber Infusion Set

Powder Free Nitrile Examination Glove

Drug Dosing Calculator

Latex Glove

I.V. Administration Sets

Reusable Pressure Infuser

Isolation Gowns

Sunglasses (OTC)

Protective Restraints

Wheelchair Restraints

PIV System

Examination gloves with Protein Claim (OTC)

Examination Gloves with Protein and Hypoallergenic Claims (OTC)

Nitrile Examination Gloves (OTC)

Polymer Coated Examination Gloves (OTC)

Non-Chlorinated Nitrile Examination Gloves (OTC)

Electronic Therometer

Isolation Gown

Acupuncture Needle

Bag Warmer

Protective Restraint

Safe Wing Cath Intravascular Catheter

I.V. Catheter

I.V. Administration Set with Flow Regulator and Filter

I.V. Fluid and Irrigation Bag Warming Cabinet

Powdered Latex surgeon’s glove

Home Use Products

Ostomy Bag Mobile App

Diagnostic Spirometer for all ages

Blood Glucose Meters for all ages

Blood Glucose Management Software

Atrial Fibrillation Monitor

Blood Pressure Monitors

Peak Flow Meters

Arterial Hardenss and Blood Pressure Monitor

Blood Pressure Monitors

Blood Glucose Test Strip

Automatic Thermal Massager

Vital Sign Recorder and Transmitter

Negative Pressure Wound Foam Dressing

Colon Rectal Screening Test

Clinical Thermometer

Anti Snoring Device


Breast Pumps



Menstrual Cup

Kegel Exerciser

External Penile Rigidity Device

Personal Lubricant

Latex Examination Gloves

Nitrile Examination Gloves

Contact Lens Product

Apnea Examination System

Neurology Branch

Gastroenterology Branch

Biopsy Gun

Vacuum Pumps for Erectile Dysfunction (OTC)

Adjustable Constriction Rings for Erectile Dysfunction (OTC)

Non-Adjustable Constriction Rings for Erectile Dysfunction (OTC)

Hemorrhoidal Ligator

Disposable Anoscope

Disposable Sigmoidoscope

Fistula Needle And Site Preparation Tool

Fistula and Apheresis Set

Irrigation set for bladder and endoscopic procedures


Fistula Needle


Sigmoidoscope and Proctoscope

Colon Hydrotherapy System

Arthroscope Irrigation Set

External Penile Rigidity device

Constriction Ring

Adjustable Constriction Rings

Adjustable and Stretchable Constriction Rings

In-Vitro Diagnostic Branch

Fecal Occult Test Sensitive (OTC)

Cell Separator

Alcohol Detector

Diabetes Software Program</>

Generic blood glucose strip

Rapid HIV-1 AntibodyScreening Test (CBER, PMA BP000023/0)

Blood Glucose Monitoring System OTC

Colon Rectal Screening Test

Gastroenterology Branch

Defibrillator Tester

Transient Evoked Otoacoustic Distortion

Product Emission System


Nasal Retainer

ILO288 Echoport plus OAE System Otocheck

ILO292 Echoport plus OAES


Laryngeal Electrode

ENT Electric surgical drill

Obstetrics/Gynecology Branch

Sonicaid System 8002 – Fetal Heart Rate Analysis Software

Mini-Manual Breast Pump (OTC)

Automatic Breast Pumps (OTC)

Micro Filter for Breast Pumps (OTC)

Vaginal Speculum

Vaginal Stent

Cervical Spatula

Umbilical Clamp

Condoms (OTC)

Kegel Exerciser (OTC)


Patient Lubricant

Organic Cotton Tampon (OTC)

Radiology Branch

Radionuclide Dosing Calculator

MRI Imaging System

MRI Electric Drill

MRI Conventional Biopsy Kit

Medical Grade CD-R Storage Media

Topographic Marker

Rectal/Vaginal Marker

Radiation Therapy Marker

MRI Enhancer

Imaging Marker

Transcranial Doppler Ultrasound

P-Electric Drilling Machine

Radiotherapy Positioning System

Super Tissue for High Energy Radiation Therapy

Solid State X-Ray Imaging System


Image-intensified Fluoroscopic X-Ray System

Radiation Treatment Planning System

Diagnostic Ultrasound System

Medical Image Management Device

Radionuclide Dose Calibrator

MR Enhancer

Super Tissue

Topographic Image Marker

Topographic Imaging Marker

CD-R PACS Accessory

Radiation Simulation System

Dental Branch

Caraloe Oral Rinse (OTC)

Dental Casting Alloys

Precious Metals Bonding Alloys

Anti-Snoring Device

Orthodontic Bracket

Ophthalmic Branch

Contact Lens Case (OTC)

Punctum Plug

Physical Medicine

Relfex Gun

Thermal Massager

Mechanical Wheelchair

CBER Division

Reveal™ Rapid HIV Test Kit (PMA cleared April 2003)

Disc Stem Cells BLA

IDE/PMA Projects

Saline Mammary Implants

Gel Mammary Implants

Polyurethane Mammary Implants

Testicular Implants

Rapid HIV Test Kits

Treatment IDE

Compassionate IDE

ADHD In Vitro Diagnostic Test

Hepatitis B Antigen Test

Hepatitis B Core Antibodies Test

We service all sized companies and classifications within your budget.