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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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CUVIS-spine - 08800043830020

No Description
CUREXO, Inc.
CS200
In Commercial Distribution

  • 08800043830020 ()


  • Robotic surgical navigation system

CUVIS-spine - 08800043830013

No Description
CUREXO, Inc.
CS100
In Commercial Distribution

  • 08800043830013 ()
CA-00000-000

  • Robotic surgical navigation system

N/A - 08800043830006

No Description
CUREXO, Inc.
CUVIS-spine
In Commercial Distribution

  • 08800043830006 ()
CA-00000-000

  • Robotic surgical navigation system

NA - 07613327395280

No Description
MAKO SURGICAL CORP.
219999
In Commercial Distribution

  • 07613327395280 ()
219999

  • Robotic surgical navigation system

STRYKER NAV3I - 07613327004175

STRYKER NAV3I(TM) PLATFORM
Stryker Leibinger GmbH & Co. KG
7700-800-000
In Commercial Distribution

  • 07613327004175 ()
7700-800-000

  • Robotic surgical navigation system

NA - 07613327624304

Robotic Arm
MAKO SURGICAL CORP.
229999
In Commercial Distribution

  • 07613327624304 ()
229999

  • Robotic surgical navigation system

NAVSUITE - 07613327114782

NavSuite3 Kit
Stryker Leibinger GmbH & Co. KG
7700-009-100
In Commercial Distribution

  • 07613327114782 ()
7700-009-100

  • Robotic surgical navigation system

Clearlens - 00885556805442

CLEARLENS TRACKING ARRAY SET KNEE(16PCS)
Smith & Nephew, Inc.
53245
In Commercial Distribution

  • 00885556805442 ()
53245

  • Robotic surgical navigation system

Clearlens - 00885556805008

CLEARLENS TRACKING ARRAY SET KNEE
Smith & Nephew, Inc.
53236
In Commercial Distribution

  • 00885556805008 ()
53236

  • Robotic surgical navigation system

S-Series OCT - 00754016215049

The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.
Perimeter Medical Imaging AI, Inc.
PMI001OCT21
In Commercial Distribution

  • 00754016215049 ()
  • 10754016215046 ()
ASY-2000

  • Dermatological optical coherence tomography system
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