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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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Hilo Bath TR 900 CW US,With Stainless Bathtub
Tr Equipment AB
05192172-SS
In Commercial Distribution

  • 07350016061308 ()


  • Hydrotherapy bath/tank
Hilo Bath TR 900 CWA US, Stainless Bathtub
Tr Equipment AB
05192177-SS
In Commercial Distribution

  • 07350016061261 ()


  • Hydrotherapy bath/tank
Hilo Bath TR 900 CWA, With Stainless Bathtub
Tr Equipment AB
05192175-SS
In Commercial Distribution

  • 07350016061254 ()


  • Hydrotherapy bath/tank
TR900 HI LO 230V UK TMV3
Tr Equipment AB
05192151
In Commercial Distribution

  • 07350016061087 ()


  • Hydrotherapy bath/tank
TR900CWA HI LO 230V Cleaning, Autofill & Whirlpool
Tr Equipment AB
05192175
In Commercial Distribution

  • 07350016060196 ()


  • Hydrotherapy bath/tank
TR900CW HI LO 230V Cleaning & Whirlpool
Tr Equipment AB
05192170
In Commercial Distribution

  • 07350016060189 ()


  • Hydrotherapy bath/tank
TR900C HI LO 230V Cleaning
Tr Equipment AB
05192160
In Commercial Distribution

  • 07350016060172 ()


  • Hydrotherapy bath/tank
TR1700 HI LO 230V incl. Mixer and shower
Tr Equipment AB
05191701
In Commercial Distribution

  • 07350016060141 ()


  • Hydrotherapy bath/tank
TR900 HI LO 230V
Tr Equipment AB
05192150
In Commercial Distribution

  • 07350016060103 ()


  • Hydrotherapy bath/tank
Ecoline with mixer, 50 MM DRAIN, H=80 CM
Tr Equipment AB
05194032
In Commercial Distribution

  • 07350016060035 ()


  • Hydrotherapy bath/tank
No Description
BELMONT INSTRUMENT CORPORATION
902-00001A-F
Not in Commercial Distribution

  • 30896128002139 ()


  • Extravascular-circulation hyperthermia system
A therapeutic laser system intended for use in providing temporary relief of minor pain. The system contains a laser console, a fiberoptic delivery cable and a wireless footswitch. Other system accessories include protective eyewear, power supply with power cords, screen protectors and batteries.
Biolase, Inc.
7400055 Refurbished
In Commercial Distribution

  • 00647529002599 ()


  • Musculoskeletal/physical therapy laser, professional
A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400054 Refurbished
In Commercial Distribution

  • 00647529002575 ()


  • General/multiple surgical diode laser system
A therapeutic laser system intended for use in providing temporary relief of minor pain. The system contains a laser console, a fiberoptic delivery cable and a wireless footswitch. Other system accessories include protective eyewear, power supply with power cords, screen protectors and batteries.
Biolase, Inc.
7400055
In Commercial Distribution

  • 00647529000267 ()
7400055

  • Musculoskeletal/physical therapy laser, professional
A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400054
In Commercial Distribution

  • 00647529000236 ()
7400054

  • General/multiple surgical diode laser system
No Description
AZENA MEDICAL, LLC
8990
Not in Commercial Distribution

  • 00861407000389 ()


  • Dental diode laser system
Hot and Heat
Therabody, Inc.
RecoveryTherm Cube
In Commercial Distribution

  • 00840295401782 ()


  • Electric pad localized-body heating system
  • Hot/cold therapy pack, reusable
SMARTLUX MINI is the combination of low power beam irradiator and infrared irradiator, and it is KGMP, CE/MDD class IIa class medical equipment. Your attention to prevent danger or injury is required. Please read User’s Manual carefully before you use medical equipment, and if you have any questions on safety, application, or operation of the equipment, please contact MEDMIX Co., Ltd. or its distributor.
Medmix Co., Ltd.
D478000
Not in Commercial Distribution

  • 08800077100045 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
OMNILUX MEDICAL PLUS HEAD
LOTUS GLOBAL GROUP, INC, THE
EM1387
In Commercial Distribution

  • B434EM1387 ()


  • Musculoskeletal/physical therapy laser, professional
  • Skin photodynamic therapy/phototherapy lamp
OMNILUX MEDICAL BASE
LOTUS GLOBAL GROUP, INC, THE
EM1258S
In Commercial Distribution

  • B434EM1258S0 ()


  • Musculoskeletal/physical therapy laser, professional
  • Skin photodynamic therapy/phototherapy lamp
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