FDA Consultants, Specializing in Medical Device Industry

510(k)'s/IDE/PMA

Smith Associates' history over the past 10 years with CDRH and CBER Divisions of the FDA has been expremely productive for our clients. Below is an overview by Branch of the many projects we have either completed or are currently under review.

Anesthesiology Branch

Hydrogen Gas Analyzer
Hygroscopic Condenser Humidifier
Anesthesia Masks
Resusciators w/CO2 Detector
Tri-Plex Adapter
Disposable Resuscitators
PEEP Valves
Metered Dose Inhalers
Heated Humidifier/Nebulizer
Oximeter
Peak Flow Meters
Resposable Resuscitators
CO2 Detector
Bacteria/Viral Filers

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)

Dental Branch

Caraloe Oral Rinse (OTC)
Dental Casting Alloys
Precious Metals Bonding Alloys
Anti-Snoring Device

Ear, Nose & Throat Branch

Defibrillator Tester
Transient Evoked Otoacoustic Distortion
Product Emission System
Echoport
Nasal Retainer
ILO288 Echoport plus OAE System Otocheck
ILO292 Echoport plus OAES

Gastroenterology Branch

Biopsy Gun
Vacuum Pumps for Erectile Dysfunction (OTC)
Adjustable Constriction Rnigs for Erectile Dysfunction (OTC)
Non-Adjustable Constriction Rings for Erectile Dysfunction (OTC)

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
I.V. Administration Sets
Reusable Pressure Infuser
Isolation Gowns
Sunglasses (OTC)
Protective Restraints
Wheelchair Restraints
PIV System
Examination gloves with Protein Claim (OTC)
Examiation Gloves with Protein and Hypoallergenic Claims (OTC)
Nitrile Examination Gloves (OTC)
Polymer Coated Examination Gloves (OTC)
Non-Chlorinated Nitrile Examination Gloves (OTC)

General and Plastic Surgery Branch

Drug Dosing Calculator
Synergy IOM System
Cryosurgical Planning System
Electrosurgical Analyzer
Self Contained Non-Invasive Skin Analysis System
Liposuction System
Liposuction Suction Pump
Electrosurgical Grounding Pads
Saline-Filled Mammary Implant
Pre-Filled Mammary Implant
Calf Implant
Gluteal Implant
Chin Implant
Oval Carving Block
Tissue Expanders
Malar Implant
Nasal "L" Shaped Implant
Biopsy Gun
Aspiration Biopsy Needle
Skin Analysis System

In-Vitro Diagnostic Branch

Fecal Occult Test Sensitive (OTC)
Cell Separator

Neurology Branch

Nervus Monitoring System
BioSomnia Monitoring System
EEG Recorder
TENS Electrodes
NeuroGate Trocar
NeuroCut Biopsy Needle
Neuro Biopsy Needle
Neuro Puncture Needle
Muscle Stimulator
Polysmith Sleep System

Obstetrics / Gynecology Branch

Sonicaid System 8002
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)
KegalMaster Exerciser (OTC)

Ophthalmic Branch

Contact Lens Case (OTC)

Physical Medicine

Relfex Gun

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

CBER Division

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

IDE/PMA Projects

Saline Mammary Implants
Gel Mammary Implants
Polyurethane Mammary Implants
Testicular Implants
Rapid HIV Test Kits
Treatment IDE
Compassionate IDE

Smith Associates

~FDA Consultants~ Specializing in Regulatory Affairs

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