Profile: Natus Medical Inc renders integrated solutions for hearing screening and diagnostics. We provide health care products for screening, detection, monitoring, hearing impairment and newborn jaundice. Our product algo3 for newborn hearing, screens both ears simultaneously, as well as our ABaer screener system provides flexibility in hearing the screening. Our Audx system is utilized by hospitals for newborn hearing screening programs.

The company was founded in 1978, has revenues of USD 5-10 Million, has ~20 employees and is ISO 9001, CE certified. NASDAQ:BABY (SEC Filings)

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• 17-Hydroxyprogesterone Radioimmunoassay Test (FDA Code: JLX / 862.1395) A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.

• Adapters & Connectors, Ventilator Adapter

• Adhesive Bandages (FDA Code: KGX / 880.5240) A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.

• Ambulatory EEG Systems

• Amplitude-Integrated Electroencephalograph (FDA Code: OMA / 882.1400) An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

• Audiometers (FDA Code: EWO / 874.1050) An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

• Auditory Evoked Response Unit

• Automatic Event Detection Software For Full-Montage Electroencephalograph (FDA Code: OMB / 882.1400)

• Battery-Powered Transilluminator (FDA Code: HJN / 886.1945) A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.

• Bilirubin Light

• Blood Collection Lancet (FDA Code: FMK / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Brainstem Response Devices

• Breathing Tube Support (FDA Code: JAY / 868.5280) A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s).

• Circumaural Hearing Protector (FDA Code: EWE)

• Clinical Colorimeter (FDA Code: JJQ / 862.2300) A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.

• Cooling (Infants) Cap (FDA Code: MXM)

• Cutaneous Electrode (FDA Code: GXY / 882.1320) A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

• Diagnostic Electromyograph (FDA Code: IKN / 890.1375) A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

• Diphenylhydantoin U.V. Spectrometry (FDA Code: LDC / 862.3350) A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

• Echo-Screenr Hearing Screener

• Electrocardiograph Electrode (FDA Code: DRX / 870.2360) An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

• Electroencephalographs (FDA Code: GWQ / 882.1400)

• Enzyme Immunoassay Test

• Epilepsy Electrodes

• Evoked Response Auditory Stimulator (FDA Code: GWJ / 882.1900) An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

• Evoked Response Electrical Stimulator (FDA Code: GWF / 882.1870) An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

• Evoked Response Photic Stimulator (FDA Code: GWE / 882.1890) An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.

• Gaseous Phase Carbon-Monoxide Gas Analyzer (FDA Code: CCJ / 868.1430) A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.

• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800)

• Gonadal Shield (FDA Code: IWT / 892.6500) A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

• Hearing Aids

• Hearing Instruments

• Hearing Screener

• Hearing Screening System

• Hot Water Pasteurization Device (FDA Code: LDS / 880.6991) A medical washer is a device that is intended for general medical purposes to clean and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.

• Infant Oxygen Hood (FDA Code: FOG / 868.5700) A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.

• Infant Position Holder (FDA Code: FRP / 880.5680) A pediatric position holder is a device used to hold an infant or a child in a desired position for therapeutic or diagnostic purposes, e.g., in a crib under a radiant warmer, or to restrain a child while an intravascular injection is administered.

• Infant Radiant Warmer (FDA Code: FMT / 880.5130) The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.

• Medical Device, Disinfector (FDA Code: MEC / 880.6992) A medical washer-disinfector is a device that is intended for general medical purposes to clean, decontaminate, disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.

• Medical Devices

• Medical Screening

• Needle Electrode (FDA Code: GXZ / 882.1350) A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

• Neonatal Eye Pad (FDA Code: FOK / 880.5270) A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.

• Neonatal Phototherapy Unit (FDA Code: LBI / 880.5700) A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.

• Newborn Care Equipment

• Newborn Hearing Screener

• Non-Normalizing Quantitative Electroencephalograph Software (FDA Code: OLT / 882.1400)

• Non-Powered Flotation Therapy Mattress (FDA Code: IKY / 880.5150) A nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or other materials that have the functionally equivalent effect of supporting a patient and avoiding excess pressure on local body areas. The device is intended to treat or prevent decubitus ulcers (bed sores).

• Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF / 880.6025) An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

• Nystagmograph, Monitor (FDA Code: GWN / 882.1460) A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.