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Address: 2580 S.E. Willoughby Blvd., Stuart, Florida 34994, USA
www.insightinstruments.com |
Phone: +1-(772)-219-9393, 800-255-8354
FDA Registration: 1052234 Annual Revenues: USD 1-5 Million
Products: Disposable Ophthalmic Cannulae, Diagnostic/Surgical Loupe (FDA Code:
FSP), Battery-Powered Vitreous Aspiration and Cutting Instrument (FDA Code:
HKP), Corneo-Scleral Punch (FDA Code:
HNJ), Diagnostic Condensing Lens (FDA Code:
HJL), Diagnostic Polymethylmethacrylate Contact Lens (FDA Code:
HJK), ...
Insight Instruments, Inc. specializes in production, development and sale of instruments to vitreo retinal surgeons. Our BIOM 3 incorporates the principle of indirect opthalmoscopy in the operating mi
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Address: 39 Sycamore Avenue, Little Silver, New Jersey 7739, USA
www.endo-optiks.com |
Send Inquiry |
Phone: +1-(732)-530-6762, 800-756-3636
FDA Registration: 2247224 Year Established: 1991
Annual Revenues: < USD 1 Million
Quality: CE Certified
Products: Ophthalmic Lasers (FDA Code:
HQF), Endoscopes Optical Adapter, Safety Goggles, General Surgery Tray (FDA Code:
LRO), Photocoagulator and Accessories (FDA Code:
HQB), Ophthalmic Endoscope (FDA Code:
KYH), ...
Endo Optiks, Inc. manufactures endoscopy systems. Our E2 Microprobe™ Laser and Endoscopy System is a compact laser and endoscopy unit that houses a light source, diode laser and video camera. Al
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Address: Concilio de Trento, 37-39, Barcelona 08018, Spain
wwww.blossgroup.com |
Send Inquiry |
Phone: +34-(93)-303 65 65
Annual Revenues: USD 5-10 Million
Employee Count: ~30
Products: Surgical Microscopes, Surgical microscope for ENT Surgeons, Ophthalmic Surgeons, Surgical microscope for Gynecologist Surgeons, Surgical Microscope Repair Service, Ophthalmic Lasers (FDA Code:
HQF), Surgical Microscopes (FDA Code:
EPT), ...
W.M. Bloss S.A. offers ophthalmologists access to the latest technological advances. We specialize in ophthalmic and pleoptic instruments. We offer auto refractometer for use in ophthalmology and opto
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Address: 37 Kodiak Crescent, Unit 16, Toronto, Ontario M3J 3E5, Canada
www.oti-canada.com |
Send Inquiry |
Phone: +1-(416)-631-9123
Products: Optical Coherence Tomography (FDA Code:
OBO), B-Scan Devices, A-Scan Devices, Optical Coherence Tomography (OCT) (FDA Code:
OBO), Three-dimensional optical coherence tomography, Functional Optical Coherence Tomography (FDA Code:
OBO), ...
Ophthalmic Technologies Inc. provides technologically advanced, easy-to-use equipment for ophthalmology. We offer products like spectral OCT/SLO, cornea lens, microperimetry, ultrasound & A-Scan, B-Sc
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FDA Code / Regulation: KYH / 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.
Classification. (1) Class II (performance standards).