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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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CyberLAB - B433CL0

Clinical Laboratory Information System application software
ASPYRA, LLC
7.3.1
In Commercial Distribution

  • B433CL0 ()
CL731

  • Clinical laboratory information system application software

360CAS - B432360CAS3110

360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.1
In Commercial Distribution

  • B432360CAS3110 ()


  • Robotic surgical navigation system application software

GoCheck Kids - B430GCKNOK44290L

Stand-alone software for GoCheck Kids Nokia.
Gobiquity, Inc.
Nokia 4.4.29
In Commercial Distribution

  • B430GCKNOK44290L ()


  • External ocular measurement camera

CAPILLAROSCOPE HIGH RESOLUTION WITH PROFESSIONAL SOFTWARE - B1623181

CAPILLAROSCOPE HIGH RESOLUTION WITH PROFESSIONAL SOFTWARE
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-318
Not in Commercial Distribution

  • B1623181 ()
FEDMEDMICFIP5MSWC_US

  • Otoscope, direct

Lilivis CAD L-CAD - 08800019600909

Lilivis CAD L-CAD (Chairside CAD Software)
Huvitz Co., Ltd.
L-CAD
In Commercial Distribution

  • 08800019600909 ()
LS-100

  • CAD/CAM software

Monarch™ Laptop P16 Software v4.1.0 - 10810068810612

Monarch™ Laptop P16 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810612 ()


  • Robotic surgical system application software

Monarch™ Laptop P17 Software v4.1.0 - 10810068810605

Monarch™ Laptop P17 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810605 ()


  • Robotic surgical system application software

Isolaz - 00816995020615

TIP, PROFUSION, MACH XL WITH SOFTWARE
SOLTA MEDICAL
40-01746
In Commercial Distribution

  • 00816995020615 ()
40-01746

  • Multi-modality skin surface treatment system

Sherlock 3CG+ TCS - 00801741188718

Sherlock 3CG+ TCS Software Version 3.1.0
Bard Access Systems, Inc.
Sherlock 3CG+ TCS Software Version 3.1.0
In Commercial Distribution

  • 00801741188718 ()
Sherlock 3CG+ TCS Software Version 3.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic

PillCam - 07290110360214

PillCam™ Web Software v9, USA
Given Imaging, Inc.
FGS-0639
In Commercial Distribution

  • 07290110360214 ()


  • Video capsule endoscopy system application software
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