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Address: 3950 Shackleford Rd. Ste 500, Duluth, Georgia 30096-1852, USA
www.givenimaging.com |
Send Inquiry |
Phone: +1-(770)-662-0870
FDA Registration: 3003141635
Products: Capsule Endoscope, Gastroenterology, Capsule Endoscope, Esophagus Capsule Endoscope, Video Capsules, RAPID Software, Cardiac Implants, ...
Given Imaging Inc. develops and manufactures swallowable imaging capsules for endoscopy. Our PillCam™ capsule endoscopy is utilized to diagnose diseases of the small intestine including crohn's
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Address: 847 Main Street, Buffalo, New York 14203-1109, USA
www.smartpillcorp.com |
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Phone: +1-(716)-8820701, 800-6444162
Year Established: 2005
Products: Intravenous Infusion Controller(CODE: QMJ), Wireless Gastrointestinal Imaging System, Capsule (FDA Code:
NEZ), Capsule Gastrointestinal Motility System (FDA Code:
NYV), ...
The Smartpill Corporation is a developer and manufacturer of ingestible, capsule-based medical devices that aid in the diagnosis, definition and therapeutic intervention of gastrointestinal disorders
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Address: 5976 Heisley Road, Mentor, Ohio 44060, USA
www.usendoscopy.com |
Send Inquiry |
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: 3000 Technology Drive, Angleton, Texas 77515, USA
www.bench.com |
Phone: +1-(409)-849-6550
FDA Registration: 2133786 Annual Revenues: USD 100-500 Million
Employee Count: ~6000
Quality: ISO 9003 Certified
Products: Glucose Glucose Dehydrogenase (FDA Code:
LFR), Over-The-Counter Blood Glucose Test System (FDA Code:
NBW), Contract Manufacturing, Engineering/Design Service, Wireless Gastrointestinal Imaging System, Capsule (FDA Code:
NEZ), Wireless Esophageal Imaging System, Capsule (FDA Code:
NSI), ...
Benchmark Electronics, Inc. offers electronics manufacturing services. We are engaged in the business of manufacturing electronics and providing services to original equipment manufacturers of telecom
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Address: 3-1 Nishi-Shinjuku 2-chome, Shinjuku-ku, Tokyo 163-0914, Japan
www.olympus.co.jp |
Phone: +81-(3)-3340-2111
FDA Registration: 8010047
Products: Flexible Endoscope Accessory Hanger, Flexible Endoscopes (FDA Code:
GCQ), Flexible Endoscope Repair Parts - Biopsy Channels, Flexible Endoscope Repair Parts - Insertion Tubes, Flexible/Rigid Bronchoscope (FDA Code:
EOQ), Non Rigid Laryngoscope (FDA Code:
CAL), ...
Olympus Imaging Corporation specializes in medical endoscopes and surgical products,artificial bone replacement material and dental products. We also deal with microscopes and the medical information
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FDA Code / Regulation: NEZ / 876.1300 An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.
Classification. Class II (special controls). The special control is FDA's guidance, "Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA."