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Address: One Edwards Way, Irvine, California 92614, USA
www.edwards.com |
Send Inquiry |
Phone: +1-(949)-250-2500
FDA Registration: 2015691 Year Established: 1958
Annual Revenues: USD 1-5 Million
Employee Count: ~5600
Quality: ISO 9001, CE Certified
Products: Annuloplasty Devices, Aortic Root Bioprostheses, Bioprosthetic Aortic Valves, Bioprosthetic Mitral Valves, Dopplers, Thrombectomy Devices, ...
Edwards Lifesciences Corporation delivers acute hemodynamic monitoring & heart valves. Our new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics a
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Address: 233-E-Erie St., Ste. 412, Chicago, Illinois 60611, USA
www.endorepairs.com |
Send Inquiry |
Phone: +1-(773)-653-9014
Products: Biopsy Forceps, Cystoscopes, Colonoscopes, Electrosurgical Systems, Bronchoscopes, Angioscope (FDA Code:
LYK), ...
Endoscope Repair Corp, L.L.C. offers a full spectrum of flexible endoscope repair services and equipment. We provide the market place with technical service, as well as medical endoscopy equipment and
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Address: P.O. BOX 9058,2 Corporate Center Drive, Melville, New York 11747-9058, USA
www.olympusamerica.com/msg_section/msg_home.asp |
Phone: +1-(631)-844-5000
FDA Registration: 2429304 Year Established: 1919
Annual Revenues: > USD 1 Billion
Employee Count: ~700
Products: Light Sources, Endoscopy Recording Systems, Endoscopic Ultrasound, Fiberoptic Bronchoscopes, Gastroenterology, Endoscopic Ultrasound system, Immuno Chemistry Analyzers, ...
Olympus America, Inc. provides portable intubation fiberoscope, standard intubation fiberscope, bronchoscope, colonoscope, gastroscope, enteroscope, duodenoscope, sigmoidoscope, choledoscope, endoscop
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Address: 22872 Avenida Empresa, Rancho Santa Margarita, California 92688, USA
www.appliedmedical.com |
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Phone: +1-(949)-713-8000
FDA Registration: 2027111 Year Established: 1987
Annual Revenues: USD 100-500 Million
Employee Count: ~1000
Quality: ISO, CE Certified
Products: Thrombectomy Catheter, Embolectomy Catheters (FDA Code:
DXE), Arterial Embolectomy Catheter, Laparoscopic Clip Appliers, Insert Clamps, Disposable Laparoscopic Scissors, ...
Applied Medical is associated with clinical areas such as general surgery, urology, vascular, cardiac, colorectal and Ob/Gyn surgery. We have introduced GelPort® laparoscopic system, Kii® abdo
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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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Address: Frobeniusweg 10, Munich 81827, Germany
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Phone: +49-(89)-429313
Annual Revenues: USD 5-10 Million
Employee Count: ~20
Products: Angioscope (FDA Code:
LYK), Automatic External Defibrillator (FDA Code:
MKJ), Interpretive Electrocardiograph, General Purpose Electrosurgical Equipment, Electroconvulsive Therapy Device (FDA Code:
GXC), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code:
GZJ), ...
Mela-Med Medical System specializes in the development, production, distribution and export of electrical stimulation therapy, microwave therapy, cardiac resuscitation, electrocardiography & vision de
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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: LYK / 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).