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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TG DE Chisel
HU-FRIEDY MFG. CO., LLC
CTG6
In Commercial Distribution

  • 10889950007379 ()
CTG6

  • Periodontal file/rasp, manual
TG DE Chisel
HU-FRIEDY MFG. CO., LLC
CTG
In Commercial Distribution

  • 10889950007362 ()
CTG

  • Periodontal file/rasp, manual
PA-Chisel - TRINOVO - TG
Kohler Medizintechnik GmbH
7645
In Commercial Distribution

  • 04251436926839 ()
7645

  • Orthopaedic chisel
Kirkland #13K/TG
Zoll-Dental
PC-Kirk13K/TG
In Commercial Distribution

  • 00840105209744 ()


  • Periodontal hoe
No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


  • Hand-held basic diagnostic x-ray system, digital
Reusable SpO2 Sensor/天荣/Finger clip/Adult/3.0M/LP6/HOSPITECNICA
Unimed Medical Supplies, Inc.
HT410-194D
In Commercial Distribution

  • 06945664822220 ()


  • Pulse oximeter probe, reusable
reSET-O® Mobile Application running on iOS. reSET-O is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with opioid use disorder (OUD). The Demo Version provides demonstration access to various prescription versions of the reSET-O product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008231 ()


  • Mental health/function therapeutic software, screen-viewed
reSET® Mobile Application running on iOS. reSET is a prescription-only digital therapy intended to deliver cognitive behavioral therapy (CBT) to patients with substance use disorder (SUD). The Demo Version provides demonstration access to various prescription versions of the reSET product and is not intended for patients.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008200 ()


  • Mental health/function therapeutic software, screen-viewed
No Description
Great Lakes Neurotechnologies Inc.
700-0026
In Commercial Distribution

  • 00859584006102 ()
700-0026

  • Tremor transducer
OVO IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impression, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. OVO IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-003
In Commercial Distribution

  • 00864206000437 ()


  • Dental milling system, CAD/CAM, chairside
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