OUR PROJECTS
Anesthesiology Branch
Hygroscopic Condenser Humidifier
Tri-Plex Adapter
Disposable Resuscitators
Metered Dose Inhalers
Pulse Oximeter
Resposable Resuscitators
Infant Resposable Resuscitator
Child Resposable Resuscitator
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
Hand-held Laparoscopic instruments
Pre-Filled Mammary Implant
Calf Implant
Gluteal Implant
Oval Carving Block
Tissue Expanders
Biopsy Gun
Electrosurgical Grounding Plate
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
Cardiovascular Branch
Cardiac Imaging Systems
Arterial Hardness and Blood Pressure
Monitors (OTC)
Patient Simulator
Digital Blood Pressure Monitor (OTC)
Wrist Digital Blood Pressure Monitor (OTC)
Non-Invasive Blood Pressure Monitor with Printer (OTC)
Cardiac Monitor
Multi-Parameter Patient Monitoring System
3 Parameter Patient Monitoring System
Noninvasive Blood Pressure Measurement System
Printer (OTC)
Central Monitoring System
Cardiac Monitor with Cardiotachometer and Alarm
Vital Signs Recorder and Transmitter
Arrhythmia Detector and Alarm including ST-Segment
Electrocardiograph Patient Simulator
Pulsecor Noninvasive Blood Pressure Measurement System
Central Nursing Station Monitoring System
Electronic Stethoscope Heart Sounds Analyzer
Angioplasty, Periphery Translumial Catheter
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
General Hospital Branch
Forehead Thermometer (OTC)
Tympanic Thermometer (OTC)
Instant Fever Thermometer (OTC)
Clinical Thermometers (OTC)
Acupuncture Needles
Fluid Warmer
Warming Cabinets
Controlled Temperature Warming Cabinets
Huber Safety Needles
Sterilization Pouches
Liberator Powered Wheelchair with Solar Companion
Blood Glucose Dosing Calculator
Clinical Electronic Thermometer
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)
Safe Wing Cath Intravascular Catheter
I.V. Catheter
I.V. Administration Set with Flow Regulator and Filter
Sharps Container
Skin Numbing Device
Arthroscope Irrigation Set
IV Fluid and Irrigation Bag Warmer
Scalp Vein Blood Collection Set
Colon Hydrotherapy System
Protective Restraints
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 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
Muscle Stimulator
Electroencephalograph
Electro-Acupuncture Stimulator
EEG Amplifier
Trancutaneous Nerve Stimulator
Transderm Iontophoresis System
Electroencephalograph Record and Process
Biosomnia Electroencephalograph
Electroencephalograph Ambulatory Recorder
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)
Disposable Anoscope
Disposable Sigmoidoscope
Fistula Needle And Site Preparation Tool
Irrigation set for bladder and endoscopic procedures
External Penile Rigidity device
Constriction Ring
In-Vitro Diagnostic Branch
Fecal Occult Test Sensitive (OTC)
Rapid HIV-1 AntibodyScreening Test (CBER, PMA BP000023/0)
Blood Glucose Monitoring System OTC
Gastroenterology 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
Image-intensified Fluoroscopic X-Ray System
Radiation Treatment Planning 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