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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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Indications for Use The OrthoGold100® is intended for : • Relief of minor muscle aches and pains • Temporary increase in local blood circulation • Activation of connective tissue
MTS Medical AG
OW100-US
In Commercial Distribution

  • 04260484571618 ()
  • 04260484571601 ()

  • Weight: 18 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000013

  • Freestanding electric massager
The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. OW100S-US is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S-US is indicated for use in conjunction with standard of care burn treatment(s)
MTS Medical AG
OW100S-US
In Commercial Distribution

  • 04260484571274 ()
  • 04260484571267 ()

  • Weight: 21 Kilogram
  • Depth: 459 Millimeter
  • Width: 400 Millimeter
  • Height: 218 Millimeter
1000024

  • Dermatological extracorporeal shock wave therapy system
ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_SW Protocol Change ver
REMED Co.,Ltd.
C-01
In Commercial Distribution

  • 08809308380546 ()


  • Magnetic neural stimulation system
ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_18.8min ver
REMED Co.,Ltd.
B-01
In Commercial Distribution

  • 08809308380539 ()


  • Magnetic neural stimulation system
ALTMS Magnetic Stimulation Therapy System_Traditional ver
REMED Co.,Ltd.
A-01
In Commercial Distribution

  • 08809308380522 ()


  • Magnetic neural stimulation system
The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast. The final product is packed in a box with neccessary parts including breast shied, silicone valve, silicone membrane, bottle, bottle connector, connector pin, airtight cap, pp bottle, nipple, screw cap, cover, power adapter and instruction for use.
UZINMEDICARE CO.,LTD
Spectra Wearable
In Commercial Distribution

  • 28809108017714 ()
  • 08809108017710 ()
MM011500

  • Breast pump, electric
The Spectra Wearable is powered breast pumps intended for use of lactating women to stimulate, express and collect milk from user’s breast. The final product is packed in a box with neccessary connecting parts including breast shied, silicone valve, silicone membrane, bottle connector, handsfree bottle, airtight cap, power adaptor and instruction for use. so, the user can use the device right after receving them.
UZINMEDICARE CO.,LTD
Spectra Wearable
In Commercial Distribution

  • 28809108017691 ()
  • 08809108017697 ()


  • Breast pump, electric
Body Composition Analyzer, Exempt
InBody Co., Ltd.
BWA2.0S
In Commercial Distribution

  • 08809209591911 ()


  • Bioelectrical body composition analyser
Body Composition Analyzer, Exempt
InBody Co., Ltd.
InBody970S
In Commercial Distribution

  • 08809209591904 ()


  • Bioelectrical body composition analyser
Body Composition Analyzer, Exempt
InBody Co., Ltd.
InBody770S
In Commercial Distribution

  • 08809209591898 ()


  • Bioelectrical body composition analyser
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