Profile: Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-level nasal CPAP for the spontaneously breathing neonate through delivery of sighs above a baseline NCPAP pressure. Our Viasprint™ 150P consists of a dual mode handlebar adjustment.

The company was founded in 2001, has revenues of USD 50-100 Million, has ~230 employees and is ISO 9001, CE certified. NYSE:CAH (SEC Filings)

FDA Registration Number: 2050001

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• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Electrosurgical Electrode (FDA Code: JOS / 878.4400)

• Emesis Basin (FDA Code: FNY / 880.6730) A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.

• EMG Polysomnography Kits

• Encephalogram Telemetry System (FDA Code: GYE / 882.1855) An electroencephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely monitoring or measuring EEG signals by means of radio or telephone transmission systems.

• Endometrial Suction Curette and Accessories (FDA Code: HHK / 884.1175) An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.

• Endoscope Accessories (FDA Code: KOG)

• Endoscopic Photographic Accessories (FDA Code: FEM / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Enema Kit (For Cleaning Purpose) (FDA Code: FCE / 876.5210) An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle either directly or via tubing. This device does not include the colonic irrigation system (876.5220).

• ENT Applicator (FDA Code: KCJ / 874.5220) An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

• ENT Elevator (FDA Code: KAD / 874.4420)

• ENT Forceps (FDA Code: KAE / 874.4420)

• ENT Irrigation Syringe (FDA Code: KCP / 874.5220)

• ENT Knife (FDA Code: KTG / 874.4420)

• ENT Manual Surgical Instrument (FDA Code: LRC / 874.4420)

• ENT Mirror (FDA Code: KAI / 874.4420)

• ENT Mobilizer (FDA Code: KAJ / 874.4420)

• ENT Nasal Gouge (FDA Code: KAQ / 874.4420)

• ENT Nerve Stimulator (FDA Code: ETN / 874.1820) A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

• ENT Probe (FDA Code: KAK / 874.4420)

• ENT Punch (FDA Code: KTF / 874.4420)

• ENT Retractor (FDA Code: KAL / 874.4420)

• ENT Syringe (FDA Code: KCP / 874.5220)

• ENT Tracheal Hook (FDA Code: KCH / 874.4420)

• EOG Polysomnography Kits

• Episiotomy Scissors (FDA Code: HDK / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• Erisophake (FDA Code: HNT / 886.4350) A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

• Esophageal Gastro-Urology Dilator (FDA Code: EZM / 876.5365) An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

• 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.

• Evoked Response Simulators

• Evoked Response Testing Systems

• Examination Gown (FDA Code: FME / 880.6265) An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.

• Extension Airway Connector (FDA Code: BZA / 868.5810) An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

• External Facial Fracture Appliance (FDA Code: FYI / 878.3250) An external facial fracture fixation appliance is a metal apparatus intended to be used during surgical reconstruction and repair to immobilize maxillofacial bone fragments in their proper facial relationship.

• External Pelvimeter (FDA Code: HER / 884.4520)

• Fetal and Vascular Dopplers

• Fetal Monitors

• Fiberoptic Light Source & Carrier (FDA Code: EQH / 874.4350) An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.

• Fiberoptic Metal Vaginal Speculum (FDA Code: HDG / 884.4520)

• Fiberoptic Retractor (FDA Code: FDG / 876.4530) A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.

• Fiberoptic Surgical Light (FDA Code: FST / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Fixation Cerclage (FDA Code: JDQ / 888.3010) A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

• Fixed Size Cervical Dilator (FDA Code: HDQ / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Flexible Depth Gauge (FDA Code: HTJ / 888.4300) A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

• Flexible Snare (FDA Code: FDI / 876.4300) An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

• Forceps (FDA Code: HTD / 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.

• Gallstone Scoop (FDA Code: FHL / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Gas Mask Head Strap (FDA Code: BTK / 868.5560) A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face.