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Address: 710 Medtronic Parkway, Minneapolis, Minnesota 55432-5604, USA
www.medtronic.com |
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Phone: +1-(763)-514-4000, 800-633-8766
FDA Registration: 2182208 Year Established: 1976
Annual Revenues: USD 1-5 Million
Employee Count: ~50
Quality: CE Certified
Products: EMG Electrodes, Bioprosthesis, Pulmonary Valved Conduit, Transcatheter Pulmonary Valve, Transcatheter Delivery System, Single Fiber EMG Software, Non-invasive Magnetic Stimulation System, ...
Medtronic, Inc. specializes in medical technology, thus providing lifelong solutions for people with chronic pain. We focus on cardiac rhythm disease management (CRDM), spinal & biologics, cardiovascu
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Address: 34 Dutch Mill Road, Ithaca, New York 14850, USA
www.transonic.com |
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Phone: +1-(607)-257-5300
FDA Registration: 1319030 Year Established: 1983
Annual Revenues: USD 10-25 Million
Employee Count: ~110
Quality: ISO 9000, ISO 9001, CE Certified
Products: Perfusion Monitors, Fiberoptic Laser Doppler Perfusion Monitors, Laser Doppler Perfusion Monitors, Perivascular Flowmeter, Neurosurgery Flowprobes, Endovascular Flowmeter, ...
Transonic Systems, Inc. delivers tools for flow verification. Our Transonic® ReoCath™ flow catheter system is a reproducible and accurate device for measuring intragraft blood flows during P
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Address: 8500 Evergreen Blvd. NW, Minneapolis, Minnesota 55433, USA
www.biovest.com |
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Phone: +1-(763)-786-0302, 866-3BIOVEST
Year Established: 1981
Annual Revenues: USD 10-25 Million
Employee Count: ~10
Quality: CE Certified
Products: Cell Culture Suspension System (FDA Code:
KJF), Perfusion Apparatus (FDA Code:
KJH), Therapeutic Cancer Vaccines, ...
Biovest International, Inc. is a vertically-integrated specialty biopharmaceutical company with services to commercialize targeted therapeutics. We also develop, manufacture and market patented cell c
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Address: 2021 Airport Road, Conroe, Texas 77301, USA
www.novosci.us |
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Phone: +1-(281)-363-4949, 800-854-0567
FDA Registration: 1625519 Year Established: 2003
Annual Revenues: USD 50-100 Million
Employee Count: ~20
Quality: ISO 13485:2003, ISO 11135 Certified
Products: Oxygen Filters, General Tubing, Medical Devices, Blood Vessel Clamps, Fluid Administration Sets, Contract Manufacturing, ...
NovoSci develops, manufactures and distributes innovative medical devices that enable the cardiologists, surgeons & perfusionists to treat cardiovascular disease. Our product categories are disposable
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FDA Code / Regulation: KJH / 864.2240 Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.
Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. If the devices are not labeled or otherwise represented as sterile, they are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.