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Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com |
Send Inquiry |
Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001
Annual Revenues: USD 50-100 Million
Employee Count: ~230
Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l
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Address: 65 Railroad Avenue, Ridgefield, New Jersey 07657, USA
www.casemed.com |
Send Inquiry |
Phone: +1-(888)-227-CASE
FDA Registration: 2248608 Year Established: 1992
Annual Revenues: USD 5-10 Million
Employee Count: ~40
Quality: ISO 9001, CE Certified
Products: Instrument Trays, Trays, Medical Procedure Trays, Operating Procedure Trays, Surgical Procedure Trays, Hospital Trays, ...
Case Medical, Inc. is a vertically integrated, product development and manufacturing facility offering custom designed & modular do-it-yourself sterilization systems for the medical industry. We are a
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Address: 735 Pennsylvania Drive, Exton, Pennsylvania 19341, USA
www.kenseynash.com |
Send Inquiry |
Phone: +1-(484)-713-2100
FDA Registration: 2530154 Year Established: 1984
Annual Revenues: USD 50-100 Million
Employee Count: ~360
Quality: ISO 9001, CE Certified
Products: Product Design & Development, Distal Embolic Protection Devices, Embolic Protection System, Guide Catheter, Embolic Protection, Vascular Closure Device, Extraction Catheter, ...
Kensey Nash Corporation is a medical device company that deals with the development of a wide variety of products for the cardiovascular, endovascular, sports medicine, spine and trauma marketplaces.
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Address: One Medline Place, Mundelein, Illinois 60060, USA
www.medline.com |
Send Inquiry |
Phone: +1-(800)-633-5463
FDA Registration: 1417592 Year Established: 1966
Annual Revenues: < USD 1 Million
Employee Count: ~6800
Quality: ISO 13485 and ISO 11135 Certified
Products: Autoclaves, Scissors, Instrument Stands, Thermometers, Endotracheal Tubes, Aspirators, ...
Medline Industries, Inc. is a manufacturer and distributor of health care supplies & services. We provide products and services to the entire continuum of care, including hospitals, extended care faci
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Address: 2909 North Neergard Avenue, Springfield, Missouri 65803, USA
Phone: +1-(314)-6283849
FDA Registration: 3004513970
Products: Cardiac Catheterization Equipment, Angiography/Angioplasty Kit (FDA Code:
OEQ), Cesarean Section Kit (FDA Code:
OHM), Custom Anesthesia Kit (FDA Code:
OGD), Ear, Nose, And Throat Surgical Tray (FDA Code:
OGR), Burn Kit Without Drug (FDA Code:
OJJ), ...
Roi, Consolidated Service Center (CSC) deals with medical kits and trays. Our product line comprises of angiography/angioplasty, burn kit without drug, cardiac catheterization, cardiovascular procedur
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Address: Zona Franca Las Americas, Autlas Americas Km 22 1-2 Sur, Santo Domingo, Dominican Republic
Phone: 847-473-1500
FDA Registration: 9680904
Products: Biopsy Instruments (FDA Code:
KNW), Biopsy Instruments (FDA Code:
KNW), Catheter Needle (FDA Code:
GCB), Surgical Needle Guide (FDA Code:
GDF), Amniotic Fluid Sampler (FDA Code:
HIO), Biopsy Needle Kit (FDA Code:
FCG), ...
Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays.
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FDA Code / Regulation: OJH / 878.4800 A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.