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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SCALER #H5/33 HOLLOW
J & J INSTRUMENTS INC
71-533
In Commercial Distribution

  • 00817524029178 ()


  • Manual dental scaler, reusable
Dental Scaler H5/5
Surgical Direct, Inc.
SD1229
In Commercial Distribution

  • B382SD12290 ()
SD1229

  • Dental elevator, tooth/root
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
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
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
OTICON ON 2.1.0 IOS
Oticon A/S
219645
In Commercial Distribution

  • 05707131395474 ()


  • 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
REMOTE CARE 1.0 IOS
Oticon A/S
193798
In Commercial Distribution

  • 05707131343932 ()


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

  • 05707131337351 ()


  • 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 1.4 IOS
Oticon A/S
178493
In Commercial Distribution

  • 05707131329981 ()


  • Hearing aid/implant system remote control
iCare PATIENT2 (iOS version)
ICARE FINLAND OY
TS05
In Commercial Distribution

  • 06430033851098 ()


  • Medical equipment clinical data interfacing software
Cara i500 ios System
Kulzer GmbH
66081716
In Commercial Distribution

  • J014660817160 ()
66081716

  • Dental milling system, CAD/CAM, laboratory
Cara i500 ios scanner
Kulzer GmbH
66077970
In Commercial Distribution

  • J014660779700 ()
66077970

  • Dental milling system, CAD/CAM, laboratory
Novidan Mobile Application - iOS
Novidan, Inc.
99-0011-02
In Commercial Distribution

  • 00850049194464 ()


  • Air-conduction hearing aid, receiver-in-canal
SOUNDLINK 2 1.9 IOS
Sonic Innovations, Inc.
189262
In Commercial Distribution

  • 05711583031880 ()


  • Hearing aid/implant system remote control
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