1 Piece PMMA IOLs,25-gauge vitrectomy system Suppliers & Manufacturers

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1 Piece PMMA IOLs
Eyekon Medical, Ciba Vision, U.s. IOL, Inc., more...

25-gauge vitrectomy system
Syntec, Inc.

3 Piece PMMA IOLs
Eyekon Medical, Ciba Vision, U.s. IOL, Inc., more...

35mm Fundus Photography
Carl Zeiss Meditec, Inc., Nidek Inc., Kowa Optimed, Inc, more...

3D Arc Scanners
Ultralink LLC

45 Vertical Microscissor
Alcon Laboratories, Inc

80 Vertical Microscissors
Pro Orthopedic Devices, DENOVO Dental Inc., Masel, more...

A-Scan Devices
Innovative Imaging Inc., Quantel Medical, Inc., Sonomed, Inc., more...

A-scan/pachymeter
Ophthalmic Instruments, Inc., Optimetrics, Inc., Meda Co., Ltd.

Absorbable Hemostats Surgicel
Absorbable hemostats surgicel is used for intraoperative hemostasis. When saturated with blood, it rapidly swells into a gelatinous mass, aiding hemostasis. It is fully absorbed within 7 to 14 days and delivers superior draping properties and bactericidal protection. It does not stick or fall apart, and is endoscopically compatible.
Kmedic, Ethicon, Inc., A.Titan Instruments, more...

Absorbable Implant (FDA Code: HQJ / 886.33)

Identification. An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.

Classification. Class II.

Mira Inc., Waqas & Company, XL - Orthomed Private Limited, more...

Absorbing Supplies
Oasis Medical, Inc., Ultracell Medical Technologies, Inc., Medtronic Ophthalmics

AC- powered Corneal Topographers (FDA Code: MMQ / 886.135)

Identification. A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.

ProTech Ophthalmics, FCI Ophthalmics, Paradigm Medical Industries, Inc., more...

AC-Powered Automatic Perimeter (FDA Code: HPT / 886.1605)

Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

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 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Synemed, Carl Zeiss Meditec, Inc., Lumenis Inc., more...

AC-Powered Biomicroscope Slit Lamp (FDA Code: HJO / 886.185)

Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Classification. Class II.

Veatch Ophthalmic Instruments, Carl Zeiss Meditec, Inc., Ophthalmic Imaging Systems, more...

AC-Powered Cryophthalmic Unit (FDA Code: HRN / 886.417)

Identification. A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.

Classification. Class II.

Dutch Ophthalmic USA, Keeler Ltd., Erbe Elektromedizin Gmbh

AC-Powered Electronic Vision Aid (FDA Code: HPF / 886.59)

Identification. An electronic vision aid is an AC-powered or battery-powered device that consists of an electronic sensor/transducer intended for use by a patient who has impaired vision or blindness to translate visual images of objects into tactile or auditory signals.

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 886.9.

Mentor Corporation, Eschenbach Optik of America Inc., Optelec US, more...

AC-Powered Euthyscope (FDA Code: HMK / 886.125)

Identification. A euthyscope is a device that is a modified AC-powered or battery-powered ophthalmoscope (a perforated mirror device intended to inspect the interior of the eye) that projects a bright light encompassing an arc of about 30 degrees onto the fundus of the eye. The center of the light bundle is blocked by a black disk covering the fovea (the central depression of the macular retinae where only cones are present and blood vessels are lacking). The device is intended for use in the treatment of amblyopia (dimness of vision without apparent disease of the eye).

Classification. Class I for the battery powered device. The battery powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. Class II for the AC-powered device.

Popper & Sons Inc

AC-Powered Keratome (FDA Code: HNO / 886.437)

Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.

Classification. Class I.

Nidek Inc., Oasis Medical, Inc., FCI Ophthalmics, more...

AC-Powered Keratoscope (FDA Code: HLQ / 886.135)

Identification. A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.

Nidek Inc., Optimetrics, Inc., Canon U.S.A., Inc., more...

AC-Powered Lens Measurment Instrument (FDA Code: HLM / 886.1425)

Identification. A lens measuring instrument is an AC-powered device intended to measure the power of lenses, prisms, and their centers (e.g., lensometer).

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 886.9.

Veatch Ophthalmic Instruments, Optimetrics, Inc., FCI Ophthalmics, more...

AC-Powered Magnet (FDA Code: HPO / 886.444)

Identification. An AC-powered magnet is an AC-powered device that generates a magnetic field intended to find and remove metallic foreign bodies from eye tissue.

Classification. Class II.

Dutch Ophthalmic USA, Bausch & Lomb, Schumann Inc., A., more...

AC-Powered Operating Headlamp (FDA Code: HPQ / 886.4335)

Identification. An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

Classification. Class I for the battery-powered device. Class II for the AC-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Laserscope, Light-Tech, Inc., Heine USA Ltd., more...

AC-Powered Ophthalmic Camera (FDA Code: HKI / 886.112)

Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Classification. Class II.

Visual Pathways, Inc., Nidek Inc., Clarity Medical Systems, Inc., more...

AC-Powered Ophthalmic Chair (FDA Code: HME / 886.114)

Identification. An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit or recline during ophthalmological examination or treatment.

Classification. Class I. The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The manual device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Marco, Woodlyn, R H Burton Company, more...

AC-Powered Ophthalmic Electrolysis Unit (FDA Code: HRO / 886.425)

Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy ocular hair follicles by applying a galvanic electrical current.

Classification. Class I for the battery-powered device. Class II for the AC-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9.

Biomet, Inc, Beijing Dakang Instrument Co., Ltd.

AC-Powered Ophthalmoscope (FDA Code: HLI / 886.157)

Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Classification. Class II.

Carl Zeiss Meditec, Inc., Ophthalmic Imaging Systems, Heidelberg Engineering, Inc., more...

AC-Powered Optical Vision Aid (FDA Code: HPI / 886.5915)

Identification. An optical vision aid is a device that consists of a magnifying lens with an accompanying AC-powered or battery-powered light source intended for use by a patient who has impaired vision to increase the apparent size of object detail.

Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Eschenbach Optik of America Inc., The Mcgee Group, Inc., CTP Coil Inc., more...

AC-Powered Perimeter (FDA Code: HOO / 886.1605)

Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

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 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

FCI Ophthalmics, Paradigm Medical Industries, Inc., Oculus, Inc., more...

AC-Powered Photostimulator (FDA Code: HLX / 886.163)

Identification. An AC-powered photostimulator is an AC-powered device intended to provide light stimulus which allows measurement of retinal or visual function by perceptual or electrical methods (e.g., stroboscope).

Classification. Class II.

Vyaire Medical, Inc., LKC Technologies, Inc., Cadwell Laboratories, Inc., more...

Ac-Powered Projection Tangent Screen (FDA Code: HOK / 886.181)

Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.

Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Reliance Medical Products

AC-Powered Pupillometer (FDA Code: HLG / 886.17)

Identification. A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.

Classification. Class I (general controls). The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The manual device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Veatch Ophthalmic Instruments, Neuroptics, Inc., U.S. Ophthalmic Llc, more...

AC-Powered Radiofrequency Cautery Apparatus (FDA Code: HQR / 886.41)

Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.

Classification. Class II.

Refractec, Inc., Mentor Corporation, Medtronic Xomed Surgical Products, Inc, more...

AC-Powered Retinoscope (FDA Code: HKL / 886.178)

Identification. A retinoscope is an AC-powered or battery-powered device intended to measure the refraction of the eye by illuminating the retina and noting the direction of movement of the light on the retinal surface and of the refraction by the eye of the emergent rays.

Classification. (1) Class II (special controls) for the AC-powered device.

Heine USA Ltd., Welch Allyn, Inc., Keeler Instruments Inc., more...

AC-Powered Stereoscope (FDA Code: HJQ / 886.187)

Identification. A stereoscope is an AC-powered or battery-powered device that combines the images of two similar objects to produce a three-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle deviation), evaluate binocular vision (usage of both eyes to see), and guide a patient's corrective exercises of eye muscles.

Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Stereo Optical Co., Inc., Wesco (Western Scientific Co Inc), Reliance Medical Products, more...

Ac-Powered Tangent Screen (Campimeter) (FDA Code: HOM / 886.181)

Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.

Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Reliance Medical Products, Takagi Seiko Co., Ltd.

AC-Powered Thermal Cautery Unit (FDA Code: HQO / 886.4115)

Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.

Classification. Class II.

Hospira, Inc., Luxtec, Kirwan Surgical Products, more...

AC-Powered Thermal Soft Lens Sterilizer (FDA Code: HRD / 886.5928)

Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

Classification. Class II (Special Controls) Guidance Document: "Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products."

Bausch & Lomb, Alcon Manufacturing, Ltd.

AC-Powered Tonometer (FDA Code: HKX / 886.193)

Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

Classification. Class II.

Mentor Corporation, Optimetrics, Inc., Canon U.S.A., Inc., more...

AC-Powered Transilluminator (FDA Code: HJM / 886.1945)

Identification. 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.

Classification. Class I for the battery-powered device. The battery-powered device is also exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 886.9. Class II for the AC-powered device.

UVP, Inc., Mira Inc., Heine USA Ltd., more...

Ac-Powered Trephine Engine Accessories (FDA Code: HRG / 886.407)

Identification. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.

Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.

Geuder AG

AC-Powered Vitreous Aspiration and Cutting Instrument (FDA Code: HQE / 886.415)

Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.

Classification. Class II.

Allergan, Inc, Abbott Medical Optics, Inc., Mentor Corporation, more...

Accommodating Intraocular Lens
Intraocular lens are the artificial lenses that replace the eye's natural lens that is removed during cataract surgery. Accommodating intraocular lens offer the possibility of seeing well at more than one distance, without glasses or contacts.
Howard Instruments, Inc., Medennium, Inc., Allergan, Inc, more...

Accommodating IOLs
Visiogen, Inc., Carl Zeiss Co., Ltd.

Accommodative Intraocular Lens (FDA Code: NAA / 886.36)

Identification. An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.

Classification. Class III.

Visiogen, Inc., Bausch & Lomb Inc., Shravan Medisales Pvt Ltd

Acrylic Sphere Implants
Opsm

Acuity Cards
Acuity Cards are the standard diagnostic tool for evaluating visual acuity in infants and non-verbal children & adults. The cards allow estimation of acuity in two to six minutes per eye and show high levels of accuracy & reliability.
Stereo Optical Co., Inc.

Adson 1 x 2 Teeth Tissue Forceps
Rusch Inc., Cambrian Medical Inc., Sontec Instruments, Inc., more...

Adson Tissue Forceps
Marina Medical Instruments Inc., Rhein Medical Inc., Elmed Inc., more...

Adson-Graefe Tissue Forceps
Rusch Inc., Cambrian Medical Inc., Sontec Instruments, Inc., more...

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