Absorbable Gelatin Material Ossicular Prosthesis,Absorbable Synthetic Nose And Throat Ear Polymer Suppliers & Manufacturers

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Absorbable Gelatin Material Ossicular Prosthesis
Jedmed Instrument Company

Absorbable Synthetic Nose And Throat Ear Polymer (FDA Code: NHB / 874.3620)

Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

Classification. Class II.

Closure Medical, Polyganics Bv, Fidia Advanced Biopolymers Srl, more...

AC-Powered Speech Training Aid (FDA Code: LEZ)
Lsvt Global LLC, Intelligent Hearing Systems, Teltec AB, more...

Acoustic Damping Systems
Preferred Products, M & S Enterprises, OTO Products Inc, more...

Acoustic Test Chamber (FDA Code: EWC / 874.1060)

Identification. An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 874.9.

Starkey Laboratories, Inc., Aesculap Inc., Kelleher Medical, Inc., more...

Acoustical Room
Proudfoot Company, Inc., Gaes SA

Adenoid Curettes (FDA Code: KBJ / 874.4420)
Viasys Healthcare Inc, Clinimed, Inc., Medtronic Xomed Surgical Products, Inc, more...

Adenoid Forceps
ML International, Smega Technologies, AAKK Surgical Corporation, more...

Adenoid Guillotine
Medicon eG

Adenoid Punches (FDA Code: KBS / 874.4420)
Viasys Healthcare Inc, Sontec Instruments, Inc., Medtronic Xomed Surgical Products, Inc, more...

Adenotomes (FDA Code: KBH / 874.4420)
Viasys Healthcare Inc, Clinimed, Inc., Kroslak Enterprises, Inc., more...

Adjustable Mastoid Retractor
Elmed Inc., Millennium Surgical Corp., Medicon eG, more...

Adult Laryngoscope Lamp
Bulbworks Inc, Sklar Instruments, Carley Lamps, more...

Aerosol Generator
Medical Industries America Inc., Air Techniques International, TSI Incorporated, more...

Air Caloric Irrigator
Air caloric irrigator is used for dry thermal examination of the vestibular organ by means of air. It features an extremely precise temperature control and an exact dosage of the airflow; with unchanged stimulation period, a constant level of the transmitted thermal energy is assured. It is suitable for use in all-medical ranges where, for medical reasons, water cannot be used as stimulating medium or in rooms with no water connection.
Micromedical Technologies, Inc., Life-Tech, Inc., GN Otometrics A/S, more...

Air Conduction Hearing Aid (FDA Code: ESD / 874.3300)

Identification. A hearing aid is wearable sound-amplifying device that is intended to compensate for impaired hearing. This generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400).

Classification. (1) Class I (general controls) for the air-conduction hearing aid. The air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 874.9.

Precision Labs Inc., Starkey Laboratories, Inc., Siemens Medical Solutions USA Inc, more...

Air Conduction Hearing Aid Transcutaneous System (FDA Code: NIX / 874.3950)

Identification. A transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal. The device consists of an air conduction hearing aid attached to a surgically fitted tube system, which is placed through soft tissue between the post auricular region and the outer ear canal.

Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled "Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA." See 874.1 for the availability of this guidance document.

Olympus Imaging Corporation

Ammonia Inhalants
Ammonia inhalants are used for nasal inhalation in the prevention or treatment of fainting.
Acme United Corporation, Mallinckrodt, Wyeth, more...

Anechoic Chambers
An Anechoic Chamber is a shielded room designed to attenuate waves. Anechoic chambers are used to provide a shielded environment for radio frequency (RF) and microwaves. An RF anechoic chamber is designed to suppress the electromagnetic wave analogy of echoes, reflected electromagnetic waves, from the internal surfaces. Both types of chambers are constructed with echo suppression features and with effective isolation from the acoustic or RF noise present in the external environment. In a well-designed acoustic or RF anechoic chamber, the equipment under test receive acoustic, mechanical or RF signals from the signal source, not reflected from another part of the chamber. This ensures the integrity of the testing being conducted. Furthermore, the shielding of the chamber limits interference from equipment located outside of the chamber.
Audiometrics, D & W Brothers Inc, MSR Northwest Inc, more...

Angular Ear Curette
Clinimed, Inc., U.S.E Surgical Instruments, Kmedic, more...

Anti-Snoring Device (FDA Code: LRK / 872.5570)

Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.

Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA."

Aztec Orthodontic Laboratory, Inc., Pureline Oralcare, Inc., BDL Prosthetics, more...

Anti-Snoring Throat Sprays
Anti-snoring throat spray combines a blend of pure essential oils to effectively help stop snoring.
Falcon Pharmaceuticals, Ltd., Gebauer Co, Mylan Pharmaceuticals Inc., more...

Anti-Stammering Device (FDA Code: KTH / 874.5840)

Identification. An antistammering device is a device that electronically generates a noise when activated or when it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 874.9.

Griffin Laboratories, Magnatone Hearing Aid Corp, Janus Development Group, Inc.

Antibacterial mouthwashes
Antibacterial mouthwashes are liquids designed to kill the bacteria that can cause tooth decay, gingivitis, periodontitis and bad breath. These mouthwashes are a mixture of detergents, colors and flavors, which may also contain some medicaments.
Falcon Pharmaceuticals, Ltd.

Antiseptic Mouthwashes
Antiseptic mouthwashes contain antiseptic to kill bacteria and help to freshen the breath. Some antiseptic mouthwashes contain chlorhexidine and are the most effective at preventing bacterial growth. These are recommended for some people with gum disease and for people with other mouth infections such as thrush. These are also used before and after surgery to avoid infections as these help to remove the bacteria in the mouth.
Falcon Pharmaceuticals, Ltd., Medical Supplies & Equipment Company LLC

Antrum Perforator (FDA Code: KAT / 874.4420)
Viasys Healthcare Inc, Medtronic Xomed Surgical Products, Inc, KLS Martin, L.P., more...

Antrum Punch (FDA Code: KAW / 874.4420)
Viasys Healthcare Inc, Medtronic Xomed Surgical Products, Inc, KLS Martin, L.P., more...

Antrum Trocars
Miltex, Inc., Derwaish Surgical Industries, Bashir, Jamil & Bros. Pvt. Ltd., more...

Artificial Battery-Powered Larynx (FDA Code: ESE / 874.3375)

Identification. A battery-powered artificial larynx is an externally applied device intended for use in the absence of the larynx to produce sound. When held against the skin in the area of the voicebox, the device generates mechanical vibrations which resonate in the oral and nasal cavities and can be modulated by the tongue and lips in a normal manner, thereby allowing the production of speech.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 874.9.

Griffin Laboratories, Cyberbiomed, LLC, Mountain Precision Mfg., Ltd., more...

Assistive Listening Device (FDA Code: LZI)
Doc's Proplugs, Sennheiser Electronic Corporation, Williams Sound Corp, more...

Assistive Listening Systems
Advanced Bionics Corporation, Micro-Tech Hearing Instruments, Clarity USA, more...

Atomizers
Sophysa USA, Inc., Aztec Medical Products, Inc., Shenzhen Kanger Technology Co., Ltd., more...

Attic Punch (FDA Code: JYX / 874.4420)
Medtronic Xomed Surgical Products, Inc, KLS Martin, L.P., Syneo, more...

Audio Spectrum Analyzer
Kaypentax

Audiometer Calibration Set (FDA Code: EWA / 874.1080)

Identification. An audiometer calibration set is an electronic reference device that is intended to calibrate an audiometer. It measures the sound frequency and intensity characteristics that emanate from an audiometer earphone. The device consists of an acoustic cavity of known volume, a sound level meter, a microphone with calibration traceable to the National Bureau of Standards, oscillators, frequency counters, microphone amplifiers, and a recorder. The device can measure selected audiometer test frequencies at a given intensity level, and selectable audiometer attenuation settings at a given test frequency.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 874.9.

Ambco Electronics, Tremetrics, Oticon Inc, more...

Audiometer Repair Services
Starkey Laboratories, Inc., MISC Inc., Welch Allyn, Inc., more...

Audiometers (FDA Code: EWO / 874.1050)

Identification. 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.

Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, "Specification for Audiometers," and subject to the limitations in 874.9.

Viasys Healthcare Inc, Preferred Products, MedRx, Inc., more...

Audiometers & Accessories
Viasys Healthcare Inc, Preferred Products, MedRx, Inc., more...

Audiometric Bone Vibrator
Radioear Corporation, Division of Sensory Device, B & K Medical A/S

Audiometric Cabinets
Vastell USA Corp., Industrial Acoustics Company GmbH

Audiometric Test Kits
Starkey Laboratories, Inc., Micro-Tech Hearing Instruments, Digital Hearing Systems Corp., more...

Audiometric Test Room Service
Starkey Laboratories, Inc., Micro-Tech Hearing Instruments, MISC Inc., more...

Audiometry Compute
Intelligent Hearing Systems, Park Surgical Co., Inc., Micro Audiometrics Corp., more...

Auditory Brainstem Implants
Auditory brainstem implants provide stimulation of the cochlear nucleus and are used in patients with an auditory nerve dysfunction, a deformed cochlea which does not allow cochlear implantation, or traumatic auditory nerve injury.
Biopro International Inc

Auditory Evoked Potential Measuring Unit
Fecom Corporation, Racia-Alvar, GN Otometrics A/S

Auditory Evoked Response Unit
Bio-Logic Systems Corp., Natus Medical Inc, Intelligent Hearing Systems, more...

Auditory Impedance Tester (FDA Code: ETY / 874.1090)

Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.

Classification. Class II.

Viasys Healthcare Inc, Medtronic Xomed Surgical Products, Inc, Starkey Laboratories, Inc., more...

Auditory Trainers
Viasys Healthcare Inc, Starkey Laboratories, Inc., M & S Enterprises, more...

Aural Magnifier
Nagashima Medical Instrument Co., Ltd., Gebrüder Martin GmbH & Co. KG,

Baby Ear Syringe
Jedmed Instrument Company, Bausch & Lomb, Aesculap Inc., more...

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