|
Address: 10 High Point Drive, Wayne, New Jersey 07470, USA
www.fujinonendoscopy.com |
Send Inquiry |
Phone: +1-(800)-490-0661
FDA Registration: 2431293 Quality: ISO 9000 Certified
Products: Laryngoscopes, Fiberoptic Bronchoscopes, Articulating Tip Laryngoscopes, Fiber Optic Blade Laryngoscopes, Conventional Laryngoscopes, Fiberoptic Laryngoscopes, ...
Fujinon, Inc. supplies endoscopic equipment. We offer the latest in endoscopic solutions for outpatient facilities, hospitals and teaching institutions. Our most advanced G-5™ endoscopes are now
more...
|
Address: 8021 Knue Rd, Suite 100, Indianapolis, Indiana 46205, USA
www.prosolv.com |
Send Inquiry |
Phone: +1-(317)-594-7431
Products: Software Programs, Picture Archiving & Communications Systems, Picture Archiving System Installation Service, Radiological Image Processing System (FDA Code:
LLZ), Radiographic Intensifying Screen (FDA Code:
EAM), Mammographic X-Ray System Full Field Digital (FDA Code:
MUE), ...
Prosolv CardioVascular deals in multi-modality image review, analysis and user-defined customized reports in a non-proprietary, open architecture environment. We support all DICOM and HL7 integrations
more...
|
Address: Wendenstr. 14-16, Hamburg 20097, Germany
www.olympus-europa.com |
Phone: +49-(40)-23773-0
Year Established: 1963
Annual Revenues: USD 100-500 Million
Employee Count: ~140
Quality: ISO 9001, ISO 9002, CE Certified
Products: Gel Electrophoresis Equipment, AC-Powered Endoscope and Accessories (FDA Code:
GCP), Electronic Endoscope, Blood Grouping Analyzer, Endoscope Sterilizer/Washer (Flexible, Sanitizer, Processor, Rigid, Cleaner, Disinfector), Colposcope and Accessories (FDA Code:
HEX), ...
Olympus Medical Systems Europa GmbH offers flexible and fixed endoscopes for cancer prevention & minimally invasive therapies. We also provide endoscopes and system solutions for a wide range of medic
more...
|
Address: Mittelstr. 8, 78532 Tuttlingen, Postfach 230, Tuttlingen 78503, Germany
www.karlstorz.com |
Send Inquiry |
Phone: +49-(7461)-708-0
FDA Registration: 9614434 Employee Count: ~2000
Quality: ISO 9000, ISO 9001, ISO 9002, ISO 9003, CE Certified
Products: Flexible, Rigid, Cameras, Cystoscopes, Nephroscopes, Percutaneous Nephroscopes, ...
Karl Storz GmbH & Co. KG specializes in the production and sale of medical instruments & devices. We offer a range of endoscopic equipment for human & veterinary medicine and for industrial applicatio
more...
FDA Code / Regulation: GCK / 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).