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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Biim iOS App, P1.2
Biim Ultrasound AS
P001157
In Commercial Distribution

  • 07090045490143 ()
P001157

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.1
Biim Ultrasound AS
P001117
In Commercial Distribution

  • 07090045490013 ()
P001117

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
On1 IOS Replica WP
Nobel Biocare AB
38742
Not in Commercial Distribution

  • 07332747176278 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
Not in Commercial Distribution

  • 07332747176261 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
Not in Commercial Distribution

  • 07332747176254 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
Chisel, Kirkland 13K/TG
Storz am Mark GmbH
12843.00
In Commercial Distribution

  • ESAM12843000 ()
  • ESAM12843001 ()
12843.00

  • Periodontal knife
#13K/TG DE Curette/Chisel
HU-FRIEDY MFG. CO., LLC
S13K/TG
In Commercial Distribution

  • 10889950022549 ()
S13K/TG

  • Periodontal file/rasp, manual
No Description
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Labat TG
In Commercial Distribution

  • 06971355420642 ()


  • General-purpose ultrasound imaging system
Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software
Mod. S13K/TG, Boston Univ
HU-FRIEDY MFG. CO., LLC
PP7065
In Commercial Distribution

  • 10889950139940 ()


  • Periodontal file/rasp, manual
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