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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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NAOS First MPJ Hemi, Porous Coated, CC - L, 23mm
HNM TOTAL RECON LLC
HTR-01-040614
In Commercial Distribution

  • 00841742101101 ()
HTR-01-040614

  • Orthopaedic bone pin, non-bioabsorbable
NAOS First MPJ Hemi, Porous Coated, CC - MS, 18.5mm
HNM TOTAL RECON LLC
HTR-01-700334
In Commercial Distribution

  • 00841742101071 ()
HTR-01-700334

  • Orthopaedic bone pin, non-bioabsorbable
NAOS First MPJ Hemi, Porous Coated, CC - S, 17mm
HNM TOTAL RECON LLC
HTR-01-040212
In Commercial Distribution

  • 00841742101064 ()
HTR-01-040212

  • Orthopaedic bone pin, non-bioabsorbable
No Description
EBM TECHNOLOGIES INCORPORATED
MobiPACS" App 1.2.1, Rad@
In Commercial Distribution

  • 04719878879989 ()


  • Radiological PACS software
No Description
EMPATICA SRL
Care App Android Version
In Commercial Distribution

  • 00853858006256 ()


  • Multiple vital physiological parameter monitoring system, home-use
Mobile Application for Hearing Screening
Gobiquity, Inc.
Hearing Mobile App V1.0.0
In Commercial Distribution

  • B43056000011000 ()


  • Tone audiometer
TPH®3 flow Liquid Micro Hybrid Compula® Tip Introductory Kit
DENTSPLY INTERNATIONAL INC.
642715
Not in Commercial Distribution

  • D0026427151 ()

  • Total Volume: 0.125 Milliliter
  • 20 Compula® Tips-5 each shade A1, A2, A3, A3.5 (0.25g each), 20 Adhesive Unit Doses, 1 Syringe Tooth Cond Gel, 1 Compules® Tips Gun, 1 Unit Dose Holder, 25 App Needles, 50 App Tips
  • Weight: 0.25 Gram
642715

  • Dental composite resin
ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStation
Kestra Medical Technologies, Inc.
80315-005
In Commercial Distribution

  • 00840241600214 ()
80315-005

  • Medical equipment clinical data interfacing software
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=305583#
BEST MEDICAL INTERNATIONAL, INC.
530-12
In Commercial Distribution

  • 00841365114328 ()


  • General-purpose brachytherapy system applicator, manual
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
W-22141
Not in Commercial Distribution

  • 00814356021516 ()


  • Dental appliance fabrication material, ceramic
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