OUR PROJECTS
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.
Anesthesiology Branch
- Hydrogen Gas Analyzer
- Hygroscopic Condenser Humidifier
- Anesthesia Masks
- Resusciators w/CO2 Detector
- Tri-Plex Adapter
- Disposable Resuscitators
- PEEP Valves
- Metered Dose Inhalers
- Double Bladed Laryngoscope
- Intelligent Dosing System
- Pressure Infusor
- Accessory to Ventilator
- Patient End Humidifier
- Heated Humidifier/Nebulizer
- Pulse Oximeter
- Peak Flow Meters for Home Use
- Pediatric Peak Flow Meter
- Resposable Resuscitators
- Infant Resposable Resuscitator
- Child Resposable Resuscitator
- Infant Resuscitator
- Child Resuscitator
- Resuscitator
- Diagnostic Spirometer
- Pulse Oximeter Simulator
- MDI Spacer
- Ultrasonic Nebulizer
- Endotracheal Tube Placement Verify System
- Oxygen mask
- Pulse Oximeter Sensors
- CO2 Detector
- Bacteria/Viral Filers
- Ventilatory Effort Recorder
- Carbon Monoxide Monitor
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
- Light Based OTC Hair Remover
- Surgical Suture
- Osseointegrated Fixtures
- Sterile Water, Normal Saline
- Hand-held Laparoscopic instruments
- Foam Dressing Kit
- NPWT Foam Dressing Kit
- A4-XLR8 Negative Pressure Foam Dressing
- NPWT AC Wound Management System
- Collagen Dressing
- Pre-Filled Mammary Implant
- Calf Implant
- Gluteal Implant
- Chin Implant
- Oval Carving Block
- Tissue Expanders
- Malar Implant
- Nasal “L” Shaped Implant
- Biopsy Gun
- Pectoral Implant
- Electrosurgical Grounding Plate
- Tissue Expander
- Trancutaneous Nerve Stimulator
- Surgical Aspiration System
- Electromyograph
- Cryotherapy Treatment Planning System
- Silicone Carving Block
- 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
- Saline-Filled Breast Implant
- Prefilled Saline-Filled Breast Implant
- MRI Conventional Biopsy Set
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
- 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
- NIBP Measurement System
- Physiological Patient Monitor
- Electrocardiograph Patient Simulator
- Pulsecor Noninvasive Blood Pressure Measurement System
- Central Nursing Station Monitoring System
- Electronic Stethoscope Heart Sounds Analyzer
- Vital Vision Arterial Stiffness and Blood Pressure Monitor
- 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
- Guiding Sheath or Catheter Introducer
- Tamarin Blue PTCA Dilation Catheter
- Catheter Introducer
- Guiding Catheter
- Microcatheter
- Safe Wing Cath Intravascular Catheter
- SensiCardiac Mobi Diagnostic Heart Murmur Application
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
- 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
- Non-chlorinated, Polymer Coated, Natural Latex Examination Glove
- Non-chlorinated, Polymer Coated, Powder Free Nitrile Examination Glove
- Powdered-Free Latex Examination GLove Black with Proteing Labeling Claim
- Powdered-Free Latex Examination Glove Violet blue green and Pink with Protein Labeling Claim
- Latex Examination Glove Violet blue Green and Pink with Protein Labeling Claim
- Non-sterile Blue Powdered Latex Examination Glove with Protein Labeling Claim
- Non-sterile Pink Colored Powdered Latex Examination Glove with or without Strawberry Scent with Protein Labeling Claim
- Non-sterile Powdered Latex Examination Glove with Protein Labeling Claim
- Powder-Free Pineapple Scented Latex Examination Glove with Protein Labeling Claim
- Non-sterile Powder-Free Green Latex Examination Glove with Protein Content Labeling Claim
- Powder-Free Blue Nitrile Examination Glove with Bubble Gum Scent
- Non-sterile Bubble Gum Powder Free Latex Examination Glove with Protein Labeling Claim
- Non-sterile Powder Free Polymer Coated Latex Examination Glove with Protein Labeling Claim
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
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
- EEG Amplifier
- iEEG
- Photic Stimulator
- Neuromonitor System
- Iontophoresis Device
- Trancutaneous Nerve Stimulator
- Transderm Iontophoresis System
- Electroencephalograph Record and Process
- Biosomnia Electroencephalograph
- Electroencephalograph Ambulatory Recorder
- Transderm Iontophoresis System
- Trocar
- MRI Biopsy Needle
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
- Endoscope
- Fistula Needle
- Anoscope
- 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
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
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)
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
- Sonoscanner
- 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
CBER Division
- Reveal™ Rapid HIV Test Kit (PMA cleared April 2003)
- Disc Stem Cells BLA
Physical Medicine
- Relfex Gun
- Thermal Massager
- Mechanical Wheelchair
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
English
Arabic
Chinese (Simplified)
Chinese (Traditional)
Dutch
French
German
Hindi
Italian
Korean
Portuguese
Russian
Spanish