Profile: Dutch Ophthalmic USA provides ophthalmic surgeons with instruments & equipment designed specifically for the demanding needs of phacoemulsification and vitreoretinal surgery. Our products include surgical system, ophthalmic surgical liquids, anterior disposable instruments, reusable instruments, surgical units, vitreoretinal instruments, and disposable vitreoretinal instruments. Our D.O.R.C. Associate® is an ophthalmic system that integrates a peristaltic and venturi pump, allowing surgeons to independently select either pump mode for phaco or vitrectomy procedures. Our D.O.R.C membrane instruments are designed to provide the vitreoretinal surgeon with an array of instruments for atraumatic dissection of vitreous membraces, and offer vitreoretinal procedures involving membrane removal. Our Eftiar® ophthalmic surgical liquids offers the vitreoretinal surgeon a temporary tamponade for efficient re-attachment of the retina, release of subretinal fluid, dissection of fibro vascular proliferation and controlling retinal bleeding.

The company is ISO 9001:2000, ISO 13485:2003, CE certified.

FDA Registration Number: 1222074

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• 80° Vertical Microscissors

• AC-Powered Cryophthalmic Unit (FDA Code: HRN / 886.4170) 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.

• AC-Powered Magnet (FDA Code: HPO / 886.4440) 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.

• AC-Powered Vitreous Aspiration and Cutting Instrument (FDA Code: HQE / 886.4150) 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.

• Battery-Powered Ophthalmoscope (FDA Code: HLJ / 886.1570) 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.

• Battery-Powered Vitreous Aspiration and Cutting Instrument (FDA Code: HKP / 886.4150)

• Biopsy Forceps

• Compact Phacoemulsification Systems

• Corneo-Scleral Punch (FDA Code: HNJ / 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.

• Cryosurgical Systems

• Curved Iris Scissors

• Curved Microscissors

• Custom-made Curved Microscissors

• Diagnostic Hruby Fundus Lens (FDA Code: HJI / 886.1395) A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.

• Diagnostic Polymethylmethacrylate Contact Lens (FDA Code: HJK / 886.1385) A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

• Diamond Knives

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 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.

• Disposable Microscissors

• Disposable Microscissors: Vertical

• Disposable Ophthalmic Cannulae

• Dyes

• End Gripping Retinal Forceps

• Endodiathermy Systems

• Endoilluminator (FDA Code: MPA / 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.

• Fibre Illumination System

• Foreign Body Retrieval Magnets

• Gases, Oils, Liquids

• Gonioscopic Prism (FDA Code: HKS / 886.1660) A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features.

• Hexon Illumination System

• Horizontal Curved Microscissors

• Horizontal Microscissors

• Iris Retractor Clip (FDA Code: HOC / 886.4350)

• Iris Scissors

• Laser Illumination Probes

• Laser Power Probe

• Laser Surgical Systems, Laser Illumination Probes

• Mechanical Vitrectomy Systems

• Micro Ophthalmic Scissors

• Microwave Diathermy (FDA Code: HPH / 890.5275) A microwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the microwave frequency bands of 915 megahertz to 2,450 megahertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

• Multiport Illumination System

• Ocular Pressure Applicator (FDA Code: LCC / 886.4610) An ocular pressure applicator is a manual device that consists of a sphygmomanometer-type squeeze bulb, a dial indicator, a band, and bellows, intended to apply pressure on the eye in preparation for ophthalmic surgery.

• Ocular Surgery Irrigation Device (FDA Code: KYG / 886.4360) An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.

• Ophthalmic Aspiration Cannula (FDA Code: HMX / 886.4350)

• Ophthalmic Cannula (FDA Code: HMX / 886.4350)

• Ophthalmic Forceps (FDA Code: HNR / 886.4350)

• Ophthalmic Knife (FDA Code: HNN / 886.4350)

• Ophthalmic Lasers (FDA Code: HQF / 886.4390) An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

• Ophthalmic Spatula (FDA Code: HND / 886.4350)

• Ophthalmic Surgery Instruments, Foreign Body Retrieval Magnets

• Ophthalmic Suture Scissors (FDA Code: HNF / 886.4350)