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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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Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500107 ()


  • Head-worn lamp
No Description
SMART MEDICAL DEVICE Co., Ltd.
DM-VME03s
Not in Commercial Distribution

  • 00193026000007 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
The G5 Flimm-Fighter Percussor is the optimum percussor for effective postural drainage at home. The Flimm-Fighter incorporates Directional-Stroking action that helps loosen congestive materials and then moves them into the upper airways, thus promoting airway clearance. The red arrow on the head of the Flimm-Fighter shows the user the direction that the loosened materials are moving inside the body. The ultra-light applicator head, weighing less than one pound, allows a patient to effortlessly receive or self-administer therapy, as it is designed for use with our self application pillow*. The continuously-variable speed range of 20 - 30 cycles per second ensures that patients receive safe, thorough treatment. Comes with applicators 250, 251, 253 & 234. A pediatric version is also available. Unit Advantages: Ideal for COPD, Cystic Fibrosis, Bronchiectasis, Chronic Bronchitis, Atelectasis, Asthma, and Bronchopulmonary Dysplasia patients needing postural drainage Extremely lightweight, the Flimm-Fighter handle weighs less than 1 pound Speed: 20 - 30 cycles per second Can be used with our self application kit* and the Vari-Tilt body positioner *Self Application Kit available separately.
GENERAL PHYSIOTHERAPY INC
FF24B
In Commercial Distribution

  • 00746980000356 ()

  • Weight: 12 Pound
FF24B

  • Hand-held electric massager
No Description
Zhejiang Nysin Medical Co.,Ltd
XFGW25-203
In Commercial Distribution

  • 06977027830610 ()


  • Electric-motor-driven wheelchair, occupant-controlled
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-32033
Not in Commercial Distribution

  • 00842271105820 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-32032
Not in Commercial Distribution

  • 00842271105813 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-32031
Not in Commercial Distribution

  • 00842271105806 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-32022
Not in Commercial Distribution

  • 00842271105714 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-32021
Not in Commercial Distribution

  • 00842271105707 ()


  • Dental appliance fabrication material, ceramic
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
SAGEMAX BIOCERAMICS, INC
Z-32020
Not in Commercial Distribution

  • 00842271105691 ()


  • Dental appliance fabrication material, ceramic
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