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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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Click2Correct/ Smart Correction software
Wishbone Medical, Inc.
C2C20210
Not in Commercial Distribution

  • B562C2C20210 ()


  • External orthopaedic fixation frame calculation software
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
No Description
OcuSciences, Inc.
OCUB100
In Commercial Distribution

  • G744OCUB100 ()


  • Scanning-laser retinal imaging system
No Description
Sira Medical, Inc.
1
In Commercial Distribution

  • G67910 ()


  • Surgical planning/navigation-enhancement system
Bolt Navigation Case
Circinus Medical Technology LLC
BN002-02
In Commercial Distribution

  • BN981BN002023 ()
BN002-02

  • Surgical planning/navigation-enhancement system
Bolt Navigation Unit, Gen 2.0
Circinus Medical Technology LLC
BN001-02
In Commercial Distribution

  • BN981BN001021 ()
BN001-02

  • Surgical planning/navigation-enhancement system
The capsule is a physiologic battery-powered device used for gastric monitoring and data collection. The tethered pH capsule is swallowed by the patient. The information gathered by the capsule contains one or more gastric parameters (i.e., pH, events and or gastric bleeding, delayed stomach emptying, or gastric dumping). The capsule is comprised of a sensor for monitoring gastric pH and movement. The telemetric signals produced by the pH capsule are detected by the patient worn transceiver. The capsules data is transmitted from the transceiver to the Heidelberg Interface module. The interface module sends the capsule information to the computer. The computer software interprets the capsule data and displays it on computer generated graph. This is a single-use device.
Heidelberg Medical Inc
Heidelberg pH Telemetric Capsules
In Commercial Distribution

  • B989HTC1020 ()
HTC102

  • Gastrointestinal telemetric monitoring system capsule, ingestible
Bolt Navigation Sterile Case used with the Bolt Navigation System
Circinus Medical Technology LLC
BN002-01-10
In Commercial Distribution

  • B981BN00201101 ()
  • B981BN00201103 ()
BN002-01-10

  • Surgical planning/navigation-enhancement system
Bolt Navigation Unit
Circinus Medical Technology LLC
BN001-01-01
In Commercial Distribution

  • B981BN0010101 ()
BN001-01-01

  • Surgical planning/navigation-enhancement system
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