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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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XIENCE Xpedition Everolimus Eluting Coronary Stent System 3.25 mm x 12 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1074325-12
In Commercial Distribution

  • 08717648162428 ()
1074325-12

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Xpedition Everolimus Eluting Coronary Stent System 2.75 mm x 28 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1074275-28
In Commercial Distribution

  • 08717648162268 ()
1074275-28

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Xpedition Everolimus Eluting Coronary Stent System 2.75 mm x 23 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1074275-23
In Commercial Distribution

  • 08717648162251 ()
1074275-23

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Xpedition Everolimus Eluting Coronary Stent System 2.75 mm x 18 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1074275-18
In Commercial Distribution

  • 08717648162244 ()
1074275-18

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Xpedition Everolimus Eluting Coronary Stent System 2.75 mm x 15 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1074275-15
In Commercial Distribution

  • 08717648162237 ()
1074275-15

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Xpedition Everolimus Eluting Coronary Stent System 2.75 mm x 12 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1074275-12
In Commercial Distribution

  • 08717648162220 ()
1074275-12

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Xpedition SV Everolimus Eluting Coronary Stent System 2.25 mm x 8 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1074225-08
In Commercial Distribution

  • 08717648162015 ()
1074225-08

  • Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 6Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-612C
In Commercial Distribution

  • M729800612C2 ()
  • M729800612C0 ()
  • M729800612C1 ()
  • M729800612C3 ()

  • Catheter Gauge: 6 to 12 French


  • Femoral artery closure plug/patch, collagen
The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to a qualified laboratory for testing.
Home Access Health Corporation
20
In Commercial Distribution

  • M769HIVEXPRESS201 ()


  • Capillary blood collection set, home-use
MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI) tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the approved therapeutic product labeling. Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed as companion diagnostic indications are not prescriptive or conclusive for labeled use of any specific therapeutic product.
CARIS MPI, INC.
MCS000
In Commercial Distribution

  • 00860008613325 ()


  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
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