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
BELMONT INSTRUMENT CORPORATION
902-00001A-T
Not in Commercial Distribution

  • 00896128002466 ()


  • Extravascular-circulation hyperthermia system
No Description
BELMONT INSTRUMENT CORPORATION
902-00015
Not in Commercial Distribution

  • 00896128002190 ()


  • Extravascular-circulation hyperthermia system
No Description
BELMONT INSTRUMENT CORPORATION
902-00013
In Commercial Distribution

  • 00896128002183 ()


  • Extravascular-circulation hyperthermia system
No Description
BELMONT INSTRUMENT CORPORATION
902-00011
Not in Commercial Distribution

  • 00896128002176 ()


  • Extravascular-circulation hyperthermia system
Heated Massager
CONAIR CORPORATION
HM40QF
In Commercial Distribution

  • 00074108355911 ()


  • External electric-heating core temperature regulation system pad
Heated Massager
CONAIR CORPORATION
HM40F
In Commercial Distribution

  • 00074108342256 ()


  • External electric-heating core temperature regulation system pad
Sebacia Microparticles Box of 9 vials
Coronado Aesthetics, LLC
SEB-250-3P-US
In Commercial Distribution

  • G256SEB2503PUS1 ()
  • G256SEB2503PUS0 ()

  • Total Volume: 3 Milliliter
SEB2503PUS

  • Photothermal therapy gel
Tissue Embedding Center, Cold Module, 230V
RUSHABH INSTRUMENTS, LLC
650CS, 230V
In Commercial Distribution

  • B92114670 ()
14670

  • Tissue embedding unit IVD
Tissue Embedding Center, Cold Module, 115V
RUSHABH INSTRUMENTS, LLC
650CS, 115V
In Commercial Distribution

  • B92114668 ()
14668

  • Tissue embedding unit IVD
Tissue Embedding Center, Cold Module, 230V
RUSHABH INSTRUMENTS, LLC
150CS, 230V
In Commercial Distribution

  • B921119661 ()
119661

  • Tissue embedding unit IVD
No Description
ORTOTECSA SL
G.18951/1000 (120V)
In Commercial Distribution

  • 08436602170261 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/1000
In Commercial Distribution

  • 08436602170254 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/400 (120V)
In Commercial Distribution

  • 08436602170247 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/290 (120V)
In Commercial Distribution

  • 08436602170209 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18957-A
In Commercial Distribution

  • 08436602170162 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/E (120V)
In Commercial Distribution

  • 08436602170148 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/D
In Commercial Distribution

  • 08436602170117 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/C
In Commercial Distribution

  • 08436602170094 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/B-1
In Commercial Distribution

  • 08436602170070 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/B (120V)
In Commercial Distribution

  • 08436602170063 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/B
In Commercial Distribution

  • 08436602170056 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/A-1
In Commercial Distribution

  • 08436602170032 ()


  • Hydrotherapy bath/tank
No Description
ORTOTECSA SL
G.18951/A
In Commercial Distribution

  • 08436602170018 ()


  • Hydrotherapy bath/tank
Cold Plate
SAKURA FINETEK U.S.A., INC.
4650
In Commercial Distribution

  • 10615233078664 ()
  • 00615233078667 ()
4650

  • Tissue embedding unit IVD
No Description
BELMONT INSTRUMENT CORPORATION
902-00001A-D
Not in Commercial Distribution

  • 20896128002132 ()


  • Extravascular-circulation hyperthermia system
Sebacia Microparticles ia a medical device consisting of engineered gold microparticles suspension intended for single use topical application. Sebacia Microparticles are designed to work as an accessory to a commercially available medically approved 1064nm laser by preferentially absorbing the light and converting it to heat, creating a focal thermal effect to the follicle and sebaceous gland for the treatment of acne vulgaris.
SEBACIA, INC.
SEB-250-3P-US
In Commercial Distribution

  • 20850002391019 ()
  • 10850002391111 ()

  • Total Volume: 3 Milliliter
SEB-250-3P-US

  • Photothermal therapy gel
No Description
BELMONT INSTRUMENT CORPORATION
902-00001A-I
Not in Commercial Distribution

  • 50896128002133 ()


  • Extravascular-circulation hyperthermia system
SWING BATH RECLING BATH 110V
Tr Equipment AB
05100007
In Commercial Distribution

  • 07350016061971 ()


  • Hydrotherapy bath/tank
SWING BATH RECLING+HEIGHT ADJ,BATH, US VERSION
Tr Equipment AB
05100008
In Commercial Distribution

  • 07350016061940 ()


  • Hydrotherapy bath/tank
Hilo-Bath TR 1700 TMV2, 40 MM DRAINAGE
Tr Equipment AB
05191743
In Commercial Distribution

  • 07350016061926 ()


  • Hydrotherapy bath/tank
Hilo-Bath TR 1700 TMV3, 40 MM DRAINAGE
Tr Equipment AB
05191742
In Commercial Distribution

  • 07350016061919 ()


  • Hydrotherapy bath/tank
No Description
Tr Equipment AB
05191714
In Commercial Distribution

  • 07350016061902 ()


  • Hydrotherapy bath/tank
TR1700 HI LO 110V incl. Mixer and shower
Tr Equipment AB
05191706
In Commercial Distribution

  • 07350016061858 ()


  • Hydrotherapy bath/tank
TR SWING BATH RECLING+HEIGHT ADJUSTIBLE BATH (ABCV01)
Tr Equipment AB
05100002
In Commercial Distribution

  • 07350016061841 ()


  • Hydrotherapy bath/tank
TR SWING BATH RECLING BATH TMV2
Tr Equipment AB
05100003
In Commercial Distribution

  • 07350016061834 ()


  • Hydrotherapy bath/tank
TR SWING BATH RECLING BATH (ABCF01)
Tr Equipment AB
05100000
In Commercial Distribution

  • 07350016061827 ()


  • Hydrotherapy bath/tank
TR1700 HI LO 230V, NO mixer
Tr Equipment AB
05191700
In Commercial Distribution

  • 07350016061810 ()


  • Hydrotherapy bath/tank
Hilo Bath TR 900CA US, With Stainless Bathtub
Tr Equipment AB
05192167-SS
In Commercial Distribution

  • 07350016061780 ()


  • Hydrotherapy bath/tank
Hilo Bath TR 900 CA, With Stainless Bathtub
Tr Equipment AB
05192165-SS
In Commercial Distribution

  • 07350016061773 ()


  • Hydrotherapy bath/tank
Ecoline with mixer, 50 MM DRAIN, H=85 CM
Tr Equipment AB
05194033
In Commercial Distribution

  • 07350016061766 ()


  • Hydrotherapy bath/tank
Ecoline with mixer, 50 MM DRAIN, H=75 CM
Tr Equipment AB
05194031
In Commercial Distribution

  • 07350016061759 ()


  • Hydrotherapy bath/tank
TR SWING BATH RECLING BATH TMV2
Tr Equipment AB
05100001
In Commercial Distribution

  • 07350016061742 ()


  • Hydrotherapy bath/tank
Ecoline with mixer, 50mm drainage
Tr Equipment AB
05194030
In Commercial Distribution

  • 07350016061735 ()


  • Hydrotherapy bath/tank
TR SWING BATH RECLING + HEIGHT ADJUSTIBLE BATH TMV3
Tr Equipment AB
05100005
In Commercial Distribution

  • 07350016061728 ()


  • Hydrotherapy bath/tank
TR SWING BATH RECLING BATH + HEIGHT ADJUSTABLE TMV3
Tr Equipment AB
05100004
In Commercial Distribution

  • 07350016061711 ()


  • Hydrotherapy bath/tank
Comfortline HI LO 230V, 50mm drain-LONG, Reverse installation
Tr Equipment AB
05194009
In Commercial Distribution

  • 07350016061704 ()


  • Hydrotherapy bath/tank
Comfortline HI LO 230V, 50mm drain, Reverse installation
Tr Equipment AB
05194008
In Commercial Distribution

  • 07350016061698 ()


  • Hydrotherapy bath/tank
Comfortline HI LO 230V incl. FMM mixer and shower AUS
Tr Equipment AB
05194007
In Commercial Distribution

  • 07350016061681 ()


  • Hydrotherapy bath/tank
Comfortline HI LO 230V, 50mm drain and pipe interrupter
Tr Equipment AB
05194006
In Commercial Distribution

  • 07350016061674 ()


  • Hydrotherapy bath/tank
Comfortline HI LO 230V, 50mm drain, NO Mixer
Tr Equipment AB
05194005
In Commercial Distribution

  • 07350016061667 ()


  • Hydrotherapy bath/tank
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