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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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No Description
TALLADIUM, INC.
19814-ATML-D3
In Commercial Distribution

  • D79119814ATMLD30 ()
19814-ATML-D3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19814-ATML-C2
In Commercial Distribution

  • D79119814ATMLC20 ()
19814-ATML-C2

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19814-ATML-B3
In Commercial Distribution

  • D79119814ATMLB30 ()
19814-ATML-B3

  • Dental appliance fabrication material, ceramic
No Description
TALLADIUM, INC.
19814-ATML-A1
In Commercial Distribution

  • D79119814ATMLA10 ()
19814-ATML-A1

  • Dental appliance fabrication material, ceramic
Inogen At Home Stationary Concentrator, CE (10-06316-XX-XX)
Inogen, Inc.
CE
In Commercial Distribution

  • 00817131020148 ()
GS-100

  • Stationary oxygen concentrator
Inogen At Home Stationary Concentrator, NCE (10-05345-XX-XX)
Inogen, Inc.
NCE
In Commercial Distribution

  • 00817131020131 ()
GS-100

  • Stationary oxygen concentrator
Aperio ePathology IVD System AT Turbo, includes; AT Turbo IVD, eSlide Manager and eIHC 510(k) Cleared Image Analysis Kit 2500
LEICA BIOSYSTEMS IMAGING, INC
23ATTIVD-2500
In Commercial Distribution

  • 00815477020068 ()

  • Device Size Text, specify:


  • Multi-modality clinical specimen analysis system IVD
For the quantitative determination of human alpha-1 anti-trypsin (Alpha-1 AT) in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-001
Not in Commercial Distribution

  • 00816426020009 ()
KAI-001

  • Trypsin-alpha-1-antitrypsin complex (elastase) IVD, reagent
The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
WND PNT.EN.GEN
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272877 ()


  • Wound management image-analysis software
No Description
Modern Dental Laboratory (DG) Co., Ltd.
188
In Commercial Distribution

  • 06972677871891 ()
  • 06972677871884 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
  • Orthodontic retainer
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