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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HEARLINK 1.0 IOS
Sbo Hearing A/S
199530
In Commercial Distribution

  • 05714464000012 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.1.0 IOS
Lehiso A/S
214712
Not in Commercial Distribution

  • 05713708000214 ()


  • Hearing aid/implant system remote control
REMOTELINK 2.0 IOS
Lehiso A/S
204456
Not in Commercial Distribution

  • 05713708000177 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.10 IOS
Lehiso A/S
199527
Not in Commercial Distribution

  • 05713708000153 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.9 IOS
Lehiso A/S
189260
Not in Commercial Distribution

  • 05713708000115 ()


  • Hearing aid/implant system remote control
REMOTELINK 1.8 IOS
Lehiso A/S
185784
Not in Commercial Distribution

  • 05713708000054 ()


  • Hearing aid/implant system remote control
CUPTIMIZE Advanced iOS
DEPUY (IRELAND)
4515-80-071
In Commercial Distribution

  • 10603295552109 ()
451580071

  • Orthopaedic stereotactic surgery system
Cuptimize for Ios
DEPUY ORTHOPAEDICS, INC.
451580054
In Commercial Distribution

  • 10603295551270 ()
451580054

  • Orthopaedic stereotactic surgery system
TG Chisel, Modified
HU-FRIEDY MFG. CO., LLC
CTG-O6
In Commercial Distribution

  • 10889950007393 ()
CTG-O6

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

  • 10889950007386 ()
CTG-O

  • Periodontal file/rasp, manual
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
KRAMER NEVINES TG
Power Dental U.S.A. Inc.
2006
In Commercial Distribution

  • D94320060 ()
2006

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe
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® 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
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
No Description
Great Lakes Neurotechnologies Inc.
700-0026
In Commercial Distribution

  • 00859584006102 ()
700-0026

  • Tremor transducer
VeriPulse IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Veripulse IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
WHIP-MIX CORPORATION
70675
Not in Commercial Distribution

  • D040706751 ()


  • Dental milling system, CAD/CAM, chairside
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
Heron IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Heron IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-001
In Commercial Distribution

  • 00864206000406 ()


  • Dental milling system, CAD/CAM, chairside
OTICON COMPANION 1.5.0 IOS
Sbo Hearing A/S
274919
In Commercial Distribution

  • 05714464146109 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.5.0 IOS
Sbo Hearing A/S
274915
In Commercial Distribution

  • 05714464146062 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.5.0 IOS
Sbo Hearing A/S
274913
In Commercial Distribution

  • 05714464146048 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.4.0 IOS
Sbo Hearing A/S
270493
In Commercial Distribution

  • 05714464139477 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.4.0 IOS
Sbo Hearing A/S
270491
In Commercial Distribution

  • 05714464139453 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.4.0 IOS
Sbo Hearing A/S
270490
In Commercial Distribution

  • 05714464139446 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.3.0 IOS
Sbo Hearing A/S
269356
In Commercial Distribution

  • 05714464133963 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.3.0 IOS
Sbo Hearing A/S
269354
In Commercial Distribution

  • 05714464133949 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.3.0 IOS
Sbo Hearing A/S
269348
In Commercial Distribution

  • 05714464133888 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.2.0 IOS
Sbo Hearing A/S
265710
In Commercial Distribution

  • 05714464127191 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.2.0 IOS
Sbo Hearing A/S
265702
In Commercial Distribution

  • 05714464127139 ()


  • Hearing aid/implant system remote control
OTICON COMPANION 1.1.0 IOS
Sbo Hearing A/S
264790
In Commercial Distribution

  • 05714464125241 ()


  • Hearing aid/implant system remote control
SOUNDLINK 3 1.1.0 IOS
Sbo Hearing A/S
264786
In Commercial Distribution

  • 05714464125203 ()


  • Hearing aid/implant system remote control
REMOTELINK 2 1.1.0 IOS
Sbo Hearing A/S
264784
In Commercial Distribution

  • 05714464125180 ()


  • Hearing aid/implant system remote control
OTICON ON 2.1.0 IOS
Oticon A/S
219645
In Commercial Distribution

  • 05707131395474 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.1.0 IOS
Sonic Innovations, Inc.
214710
In Commercial Distribution

  • 05711583038216 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 2.0 IOS
Sonic Innovations, Inc.
204547
In Commercial Distribution

  • 05711583037455 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.10 IOS
Sonic Innovations, Inc.
199525
In Commercial Distribution

  • 05711583037417 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.9 IOS
Sonic Innovations, Inc.
189262
In Commercial Distribution

  • 05711583031880 ()


  • Hearing aid/implant system remote control
SOUNDLINK 2 1.8 IOS
Sonic Innovations, Inc.
185787
In Commercial Distribution

  • 05711583030142 ()


  • Hearing aid/implant system remote control
REMOTE CARE 1.0 IOS
Oticon A/S
193798
In Commercial Distribution

  • 05707131343932 ()


  • Hearing aid/implant system remote control
OTICON ON 1.8 IOS
Oticon A/S
185783
In Commercial Distribution

  • 05707131335074 ()


  • Hearing aid/implant system remote control
OTICON ON 2.0 IOS
Oticon A/S
204454
In Commercial Distribution

  • 05707131357601 ()


  • Hearing aid/implant system remote control
OTICON REMOTECARE 3.0 IOS
Oticon A/S
204452
In Commercial Distribution

  • 05707131357588 ()


  • Hearing aid/implant system remote control
REMOTE CARE 2.0 IOS
Oticon A/S
199529
In Commercial Distribution

  • 05707131349231 ()


  • Hearing aid/implant system remote control
OTICON ON 1.10 IOS
Oticon A/S
199520
In Commercial Distribution

  • 05707131349224 ()


  • Hearing aid/implant system remote control
OTICON ON 1.9 IOS
Bernafon AG
189258
In Commercial Distribution

  • 05707131337351 ()


  • Hearing aid/implant system remote control
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