Consultants Specializing in Regulatory Affairs for FDA Compliance

Projects

Smith Associates' history over the past 18 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.


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
  • Pulse Oximeter
  • Peak Flow Meters for Home Use
  • Resposable Resuscitators
  • CO2 Detector
  • Bacteria/Viral Filers
  • Ventilatory Effort Recorder
  • Carbon Monoxide Monitor
  • Diagnostic Spirometer
  • Pulse Oximeter Simulator
  • MDI Spacer
  • Ultrasonic Nebulizer
  • Endotracheal Tube Placement Verify System
  • Oxygen mask
  • Pulse Oximeter Sensors

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)
  • Printer (OTC)
  • Central Monitoring System
  • Cardiac Monitor with Cardiotachometer and Alarm
  • Tab Electrode
  • Vital Signs Recorder and Transmitter
  • Neonatal ECG Electrode
  • Arrhythmia Detector and Alarm including ST-Segment
  • Compressible Limb Sleeve
  • Angioplasty, Periphery Translumial Catheter
  • Defibrillator Tester
  • Diagnostic Intravascular Catheter
  • Electronic Stethoscope with heart sound analysis mobile app
  • SpO2 Analyzer-Atrial Fibrillation monitor for home use
  • Catheter introducer, multiple access valve
  • Diagnostic Heart murmur software
  • Non-invasive peripheral vascular diagnostic system

Dental Branch

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

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
  • Audiometer
  • Laryngeal Electrode
  • ENT Electric surgical drill

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

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)
  • Examination Gloves with Protein and Hypoallergenic Claims (OTC)
  • Nitrile Examination Gloves (OTC)
  • Polymer Coated Examination Gloves (OTC)
  • Non-Chlorinated Nitrile Examination Gloves (OTC)
  • Sharps Container
  • Skin Numbing Device
  • Arthroscope Irrigation Set
  • Safety Needle Guard
  • Endoscope Holder
  • IV Fluid and Irrigation Bag Warmer
  • Disposable Sharps Container
  • Scalp Vein Blood Collection Set
  • Safety Blood Collection Set
  • Colon Hydrotherapy System
  • Protective Restraints
  • Pressure Infusor
  • Safety Syringe

General and Plastic Surgery Branch

  • Drug Dosing Calculator
  • Synergy IOM System
  • Cryosurgical Planning System
  • Electrosurgical Analyzer
  • 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
  • Wound Dressings
  • Iontophoresis System
  • Negative Pressure Wound Therapy Dressing
  • 2,3, 5 10 channel Electromyograph
  • Total Hip Replacement System
  • Intense Pulse Light Systems
  • Electrosurgical coagulation

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)

Neurology Branch

  • Nervus Monitoring System
  • Ambulatory EEG for Diagnosis of Sleep Disorders
  • EEG 36 Channel Ambulatory Recorder
  • TENS Electrodes
  • NeuroGate Trocar
  • NeuroCut Biopsy Needle
  • Neuro Biopsy Needle
  • Neuro Puncture Needle
  • Muscle Stimulator
  • Electroencephalograph
  • Double shoot Biopsy Gun
  • Electro-Acupuncture Stimulator

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)
  • Perineometer
  • Patient Lubricant
  • Organic Cotton Tampon (OTC)

Ophthalmic Branch

  • Contact Lens Case (OTC)
  • Punctum Plug

Physical Medicine

  • Relfex Gun
  • Thermal Massager
  • Mechanical Wheelchair

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

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
  • TENS
  • Breast Pumps
  • Tampon
  • Condoms
  • Menstrual Cup
  • Kegel Exerciser
  • External Penile Rigidity Device
  • Personal Lubricant
  • Latex Examination Gloves
  • Nitrile Examination Gloves
  • Contact Lens Product
  • Apnea Examination System

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

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