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Address: 16333 Bay Vista Drive, Clearwater, Florida 33760, USA
www.sensidyne.com |
Send Inquiry |
Phone: +1-(727)-530-3602, 800-451-9444
Year Established: 1983
Annual Revenues: USD 10-25 Million
Employee Count: ~100
Quality: ISO 9000, ISO 9001, CE Certified
Products: Oxygen Sensors, Neonatal Adult Oxygen Sensor, Respiratory Therapy Unit Calibrator, Medical Gas Leakage Detector, Personal Environmental Contamination Monitor, Endoscopic Non-Manual Air Pump (FDA Code:
FEQ), ...
Sensidyne, LP manufactures air monitoring systems. We offer air sampling pumps, detector tubes and micro air pumps. Our gas detector tubes monitor a variety of target gases and vapors.
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Address: 5976 Heisley Road, Mentor, Ohio 44060, USA
www.usendoscopy.com |
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Phone: +1-(440)-639-4494, 800-769-8226
FDA Registration: 1528319 Year Established: 1991
Annual Revenues: USD 10-25 Million
Employee Count: ~200
Quality: ISO 13485 Certified
Products: Biopsy Forceps, Bite Block (FDA Code:
JXL), Catheter Cannula (FDA Code:
DQR), Endoscope Cleaning Brushes & Accessories (FDA Code:
MNL), Endoscope Accessories (FDA Code:
KOG), Endoscopic Cytology Brush (FDA Code:
FDX), ...
US Endoscopy Group specializes in the design and manufacture of accessories for GI endoscopy. The BioShield® biopsy valves & irrigation accessories are used for single-use & offer protection for p
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Address: KeyMed House,Stock Road, Southend-on-Sea, Essex SS2 5QH, United Kingdom
www.keymed.co.uk |
Send Inquiry |
Phone: +44-(1702)-616333
Annual Revenues: USD 100-500 Million
Employee Count: ~700
Quality: ISO 9001, CE Certified
Products: Articulating Tip Laryngoscopes, Alligator Jaw-step Biopsy Forceps, Biliary & Pancreatic Procedures, Linearguide V, Biliary & Pancreatic Procedures, Billiary Stenting Kits, Biliary & Pancreatic Procedures, Biopsy Forceps, Biliary & Pancreatic Procedures, Guide Wires, ...
Olympus KeyMed Ltd. manufactures and supplies specialized medical & industrial equipments. We manufacture high-quality electro-optical products, such as cameras & microscopes and endoscopic instrument
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Address: 8, Rheinstrasse, Teltow 14513, Germany
www.celon.com |
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Phone: +49-(33)-2835190
FDA Registration: 3003724334 Quality: ISO 9001, ISO 13485. Certified
Products: Electrosurgical Cutting and Coagulation Device (FDA Code:
GEI), Endoscopic Non-Manual Air Pump (FDA Code:
FEQ), ...
Celon AG Medical Instruments specializes in providing bipolar radio frequency technology used in minimally invasive medicine. Our Celonprosleep plus utilizes RFITT-applicator, which is ideal for combi
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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
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FDA Code / Regulation: FEQ / 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).