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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBL-56-12-A13-20
In Commercial Distribution

  • 05055715612371 ()


  • Abdominal aorta endovascular stent-graft
Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBL-106-16-A13-20
In Commercial Distribution

  • 05055715612333 ()


  • Abdominal aorta endovascular stent-graft
Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBL-106-14-A13-20
In Commercial Distribution

  • 05055715612326 ()


  • Abdominal aorta endovascular stent-graft
Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBL-106-12-A13-20
In Commercial Distribution

  • 05055715612319 ()


  • Abdominal aorta endovascular stent-graft
Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System
LOMBARD MEDICAL LIMITED
SG-HBL-106-10-A13-20
In Commercial Distribution

  • 05055715612302 ()


  • Abdominal aorta endovascular stent-graft
Lithium - Sulfur Dioxide battery for replacement in Lifepak 500(TM) AED.
AED BATTERY EXCHANGE, LLC
500-ABE
In Commercial Distribution

  • 00864312000222 ()


  • Primary battery
Blood pump PU valves; 60 mL in/out; Ø 12 mm
Berlin Heart GmbH
P60P-001
In Commercial Distribution

  • 04260090040027 ()

  • Total Volume: 60 Milliliter


  • External ventricular circulatory assist system
The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.
GAMBRO INDUSTRIES
114093
In Commercial Distribution

  • 07332414111038 ()
  • 37332414111039 ()
114093

  • Apheresis system filter, whole blood
Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL syringe is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
FIDIA FARMACEUTICI SPA
89122-0724-20
Not in Commercial Distribution

  • M71389122072420A1 ()
89122-0724-20

  • Synovial fluid supplementation medium
Hyalgan® Sodium Hylauronate (20mg/2mL) in the 2mL vial is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, e.g., acetaminophen. It is a viscous solution of purified natural Sodium Hylauronate (Hyalectin®) in buffered physiological sodium chloride. The sodium hylauronate is extracted from rooster combs. It is given by intra-articular injection in a treatment cycle consisting of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly cycles. This has been noted in studies reported in the literature in which patients treated with three injections were followed for 60 days.
FIDIA FARMACEUTICI SPA
89122-0724-12
In Commercial Distribution

  • M71389122072412A1 ()
89122-0724-12

  • Synovial fluid supplementation medium
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