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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CERAMAGE UP TG 5G
SHOFU DENTAL CORPORATION
2364
In Commercial Distribution

  • E23523640 ()
2364

  • Dental prosthesis veneer resin
Ceramage Trans Effects TG
SHOFU DENTAL CORPORATION
1934
In Commercial Distribution

  • E23519340 ()
1934

  • Dental prosthesis veneer resin
PK, TG HEART ACCESSORY
MEDLINE INDUSTRIES, INC.
DYNJ88616
In Commercial Distribution

  • 40198459185107 ()
  • 10198459185106 ()
DYNJ88616

  • General surgical procedure kit, non-medicated, single-use
CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external
WVSM Management Suite - iOS
ATHENA GTX, INC.
iOS Software
In Commercial Distribution

  • B3943950006000 ()
395-0006-00

  • Centralized patient monitor
Biim iOS App, P2.0
Biim Ultrasound AS
P001424
In Commercial Distribution

  • 07090045490327 ()
P001424

  • Hand-held ultrasound imaging system, body-surface
  • Extracorporeal ultrasound imaging transducer, hand-held
Biim iOS App, P1.3.2
Biim Ultrasound AS
P001417
In Commercial Distribution

  • 07090045490303 ()
P001417

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.3.1
Biim Ultrasound AS
P001402
In Commercial Distribution

  • 07090045490228 ()
P001402

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.3
Biim Ultrasound AS
P001227
In Commercial Distribution

  • 07090045490181 ()
P001227

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
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
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