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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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The proximal femur intramedullary nail is intended for use in the fixation of proximal fractures in the femur.
CARBOFIX ORTHOPEDICS LTD
Proximal Femur Nail
Not in Commercial Distribution

  • 07290109331614 ()

  • Angle: 135 degree
  • Length: 220 Millimeter
  • Insertion Diameter: 10 Millimeter
  • Expanded Diameter: 16 Millimeter
  • Proximal Diameter: 14 Millimeter
4360322

  • Femur intramedullary nail
The proximal femur intramedullary nail is intended for use in the fixation of proximal fractures in the femur.
CARBOFIX ORTHOPEDICS LTD
Proximal Femur Nail
Not in Commercial Distribution

  • 07290109331607 ()

  • Proximal Diameter: 14 Millimeter
  • Expanded Diameter: 16 Millimeter
  • Insertion Diameter: 10 Millimeter
  • Length: 220 Millimeter
  • Angle: 130 degree
4360222

  • Femur intramedullary nail
The proximal femur intramedullary nail is intended for use in the fixation of proximal fractures in the femur.
CARBOFIX ORTHOPEDICS LTD
Proximal Femur Nail
Not in Commercial Distribution

  • 07290109331584 ()

  • Angle: 125 degree
  • Length: 220 Millimeter
  • Insertion Diameter: 10 Millimeter
  • Expanded Diameter: 16 Millimeter
  • Proximal Diameter: 14 Millimeter
4360122

  • Femur intramedullary nail
The proximal femur intramedullary nail is intended for use in the fixation of proximal fractures in the femur.
CARBOFIX ORTHOPEDICS LTD
Proximal Femur Nail
Not in Commercial Distribution

  • 07290109331683 ()

  • Right/Left: R
  • Proximal Diameter: 14 Millimeter
  • Expanded Diameter: 16 Millimeter
  • Insertion Diameter: 10 Millimeter
  • Length: 340 Millimeter
  • Angle: 135 degree
436R334

  • Femur intramedullary nail
The OmniAmp is an amplifier system for use in polysomnogram (PSG) studies in a hospital or diagnostic center.
Mays & Asscoiates
OmniAmp PSG Module
In Commercial Distribution

  • B62536084000 ()

  • Height: 3.8 Centimeter
  • Width: 15.5 Centimeter
  • Length: 20.5 Centimeter
  • Weight: 675 Gram
360-8400

  • Polysomnograph
AFIAS-6/VB Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassats for measuring the concentration of designated analytes in venous whole blood samples..
Boditech Med Inc.
FPRR020-5
In Commercial Distribution

  • 08806133010082 ()
FPRR020-5

  • Thyroid stimulating hormone (TSH) IVD, reagent
AFIAS-6/SP Analyzer is a flurorescence-scanning for in vitro diagnostic use at clinical laboratories and Point-Of-Care(POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassats for measuring the concentration of designated analytes in serum or plasma samples.
Boditech Med Inc.
FPRR020-4
In Commercial Distribution

  • 08806133010075 ()
FPRR020-4

  • Thyroid stimulating hormone (TSH) IVD, reagent
Smoke Evacuation Tubing (Non-Sterile) 7/8 in (22 mm) x 6 ft (1.8 m) with 7/8 in (22 mm) to 1/4 in (6.4 mm) reducer to 1/4 in (6.4 mm) x 2 ft (.6 m) tubing
Conmed Corporation
PSFTS05
In Commercial Distribution

  • 30845854061514 ()
  • 20845854061517 ()
  • 00845854061513 ()
  • 00851136002334 ()
PSFTS05

  • Surgical plume evacuation system tube
MERIFLUOR VZV is an in vitro direct immunofluorescent detection procedure for the detection of varicella-zoster virus (VZV) in vesicle smears and biopsy specimens. in addition, the reagent can be used to confirm the presence of VZV in cell culture.
MERIDIAN BIOSCIENCE, INC.
500113
In Commercial Distribution

  • 00840733101212 ()
500113

  • Varicella-zoster virus (VZV) antigen IVD, kit, direct fluorescent test (DFT)
The “Tyto Insights for Wheeze Detection” is an over-the-counter artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics. It automatically analyses the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Wheeze” is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.
TYTO CARE LTD
Tyto Insights for Wheeze Detection _US
In Commercial Distribution

  • 07290016672886 ()


  • Electronic acoustic stethoscope
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