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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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Tuning Device
OTTO BOCK HEALTHCARE
560X11=V2
In Commercial Distribution

  • B155EM40 ()
  • 04032767832866 ()


  • Portable computer
Platelet Aggregometer Profiler Model PAP-8E
Bio/Data Corporation
PAP-8E
In Commercial Distribution

  • G0561060771 ()
106077

  • Platelet aggregation analyser IVD
Platelet Aggregometer Profiler Model PAP-8E
Bio/Data Corporation
PAP8E
In Commercial Distribution

  • G0561060751 ()
106075

  • Platelet aggregation analyser IVD
No Description
HELENA LABORATORIES CORPORATION
8JF52001
In Commercial Distribution

  • M5258JF520010 ()


  • Platelet aggregation analyser IVD
No Description
HELENA LABORATORIES CORPORATION
1487000
In Commercial Distribution

  • M52514870000 ()


  • Platelet aggregation analyser IVD
No Description
HELENA LABORATORIES CORPORATION
1484002
In Commercial Distribution

  • M52514840020 ()


  • Platelet aggregation analyser IVD
No Description
HELENA LABORATORIES CORPORATION
1484001
In Commercial Distribution

  • M52514840010 ()


  • Platelet aggregation analyser IVD
No Description
HELENA LABORATORIES CORPORATION
1484000
In Commercial Distribution

  • M52514840000 ()


  • Platelet aggregation analyser IVD
iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400052
In Commercial Distribution

  • J00714000520521 ()
1400052

  • Surgical power tool system control unit, line-powered
  • Dental treatment application software
The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR. The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg).
CLEAR GUIDE MEDICAL, INC.
CGSCENERGYTP
In Commercial Distribution

  • B201CGSCENERGYTP0 ()
  • B201CGSCENERGYTP1 ()
CG-SCENERGY-TP

  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software
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