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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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SINUREP - 08055002909587

Breast localization needle 20G x 120 mm
MEDAX SRL UNIPERSONALE
SR20120-03
In Commercial Distribution

  • 18055002909584 ()
  • 08055002909587 ()


  • Imaging lesion localization marker, external, single-use

SINUREP - 08055002909556

Breast localization needle 20G x 80 mm
MEDAX SRL UNIPERSONALE
SR20080-03
In Commercial Distribution

  • 18055002909553 ()
  • 08055002909556 ()


  • Imaging lesion localization marker, external, single-use

N/A - 03596010378736

AUTOSENSOR MASS BLADE
Smith & Nephew, Inc.
3576
Not in Commercial Distribution

  • 03596010378736 ()
3576

  • Arthroscopic shaver system, electrically-powered

Celbrea TMD - B737WC0010

Breast Thermal Activity Indicator
WELWAZE MEDICAL INC
WC0010
In Commercial Distribution

  • B737WC0010 ()
WC0010

  • Liquid-crystal thermography system

Koresway - 00008600088282

The FDA-listed KoreSway™ Kompact incorporates the patented Korebalance™ software suites into a compact and affordable package. Utilizing proven force transducers and rapid sampling rates, the KoreSway™ captures the minute patient center of gravity movements. Includes a portable safety rail system with integrated wheels that fits through standard-size doorways.
Diversified Healthcare Development, LLC
KB05
In Commercial Distribution

  • 00008600088282 ()


  • Balance/cognitive function analysis system

DIEGO ELITE - 00821925040632

LARYNGEAL BLADE, 4 mm debulking 22 cm length, DIEGO ELITE
Gyrus ACMI, LLC
LB4022SD
In Commercial Distribution

  • 00821925028074 ()
  • 00821925040632 ()


  • ENT shaver system

DIEGO ELITE - 00821925040625

SHAVER BLADE, 4 MM, 40 DEGREES bipolar distal suction, SERRATED DIEGO ELITE
Gyrus ACMI, LLC
LB2922SS
In Commercial Distribution

  • 00821925028050 ()
  • 00821925040625 ()


  • ENT shaver system

DIEGO ELITE - 00821925038424

LARYNGEAL BLADE, 2.9 mm superficial 27 cm length, DIEGO ELITE
Gyrus ACMI, LLC
LB2927SS
In Commercial Distribution

  • 00821925028067 ()
  • 00821925038424 ()


  • ENT shaver system

MEDWIRE - 08052286428278

Repositionable system for localization of non palpable breast lesions 20G x 100mm J Type
MEDAX SRL UNIPERSONALE
XW20100-0J
In Commercial Distribution

  • 18052286428275 ()
  • 08052286428278 ()


  • Imaging lesion localization marker, external, single-use

MEDWIRE - 08052286425901

Repositionable system for localization of non palpable breast lesions 20G x 70mm J Type
MEDAX SRL UNIPERSONALE
XW20070-0J
In Commercial Distribution

  • 18052286425908 ()
  • 08052286425901 ()


  • Imaging lesion localization marker, external, single-use
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