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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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No Description
VISIA IMAGING SRL
1240400
In Commercial Distribution

  • 08034028770180 ()
1240400

  • Corneal topography system analyser
WAVENET PLANNING SOFTWARE
Alcon Laboratories, Inc.
8065000456
In Commercial Distribution

  • 00380650004567 ()


  • Laser application software
ALLEGRETTO WAVE EYE-Q EXCIMER
Alcon Laboratories, Inc.
8065990817
Not in Commercial Distribution

  • 00380659908170 ()
8065990817

  • Laser application software
F&P InfoUSB
FISHER & PAYKEL HEALTHCARE LIMITED
900ICON203
In Commercial Distribution

  • 09420012429100 ()
  • 09420012424266 ()
900ICON203

  • Digital storage media
F&P InfoUSB
FISHER & PAYKEL HEALTHCARE LIMITED
900ICON202
In Commercial Distribution

  • 09420012427854 ()
  • 09420012423115 ()
900ICON202

  • Digital storage media
SMARTSTICK-5 PACK HC254
FISHER & PAYKEL HEALTHCARE LIMITED
900HC611
In Commercial Distribution

  • 09420012421524 ()
900HC611

  • Digital storage media
No Description
E-SWIN
N040US000A08A
In Commercial Distribution

  • 03662824003048 ()


  • Corneal topography system analyser
No Description
E-SWIN
V040US000A08A
In Commercial Distribution

  • 03662824001846 ()


  • Corneal topography system analyser
Data logger for Bravo Chamber Autoclave
Scican Ltd
01-111730
In Commercial Distribution

  • 07540196002394 ()
01-111730

  • Digital storage media
Data logger for Bravo Chamber Autoclave
Scican Ltd
01-111729
In Commercial Distribution

  • 07540196002387 ()
01-111729

  • Digital storage media
Data logger for Statim Cassette Autoclaves and Hydrim Instrument Washers
Scican Ltd
01-111770
In Commercial Distribution

  • 07540196000963 ()
01-111770

  • Digital storage media
KIT MMT-7306 USB CARELINK 2.4 RF INSERT
MEDTRONIC MINIMED, INC.
MMT-7306
In Commercial Distribution

  • 00763000253325 ()


  • Digital storage media
Spine System Software
Fusion Robotics, LLC
5005
In Commercial Distribution

  • 00850026574364 ()


  • Robotic surgical navigation system application software
"The E-LINK Upper Limb Exerciser is designed for active and active resistive upper extremity exercise of the wrist, forearm, elbow, and shoulder. The versatility of the parameters allows rehabilitation for a wide range of orthopedic and neurological patients. The Upper Limb Exerciser is available with either a wireless or wired interface to the computer."
BIOMETRICS LIMITED
E4000
In Commercial Distribution

  • 05060481690010 ()


  • Electronic torsional hand exerciser
ORTHOMAP¿ PRECISION KNEE 5.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6003-655-000
In Commercial Distribution

  • 04546540717443 ()
6003-655-000

  • Robotic surgical navigation system application software
FLUOROSCOPY SOFTWARE 2.3
Stryker Leibinger GmbH & Co. KG
6004-650-000
In Commercial Distribution

  • 04546540505712 ()
6004-650-000

  • Robotic surgical navigation system application software
ORTHOMAP¿ 3D 2.0 - PLANNING
Stryker Leibinger GmbH & Co. KG
6005-661-000
In Commercial Distribution

  • 04546540651624 ()
6005-661-000

  • Robotic surgical navigation system application software
ORTHOMAP¿ 3D 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6005-660-000
In Commercial Distribution

  • 04546540651600 ()
6005-660-000

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE THA ACA
Aesculap AG
FS229
Not in Commercial Distribution

  • 04046963989101 ()
FS229

  • Robotic surgical navigation system application software
ORTHOPILOT SOFTWARE TKA SMART
Aesculap AG
FS228
Not in Commercial Distribution

  • 04046963977979 ()
FS228

  • Robotic surgical navigation system application software
No Description
Orthosoft Inc
20-8087-700-00
In Commercial Distribution

  • 00887868558306 ()
20808770000

  • Robotic surgical navigation system application software
No Description
Orthosoft Inc
20-8020-150-01
In Commercial Distribution

  • 00889024594036 ()


  • Robotic surgical navigation system application software
No Description
Orthosoft Inc
20-8020-013-00
In Commercial Distribution

  • 00889024505230 ()
20-8020-013-00

  • Robotic surgical navigation system application software
No Description
Orthosoft Inc
20-8020-140-01
In Commercial Distribution

  • 00889024511347 ()
20-8020-140-01

  • Robotic surgical navigation system application software
No Description
Orthosoft Inc
20-8020-130-01
In Commercial Distribution

  • 00889024511330 ()
20-8020-130-01

  • Robotic surgical navigation system application software
360 CAS Accessories Set Nav Tower [100-115V]
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-SET-0029
In Commercial Distribution

  • B432360CASSET00290 ()


  • Robotic surgical navigation system application software
360 CAS Laptop Camera Set
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-SET-0028
In Commercial Distribution

  • B432360CASSET00280 ()


  • Robotic surgical navigation system application software
360 CAS Accessories Set Nav 2.0 [100-115V]
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-SET-0023
In Commercial Distribution

  • B432360CASSET00230 ()


  • Robotic surgical navigation system application software
360CAS Accessories Set - Dual Camera
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-SET-0022
In Commercial Distribution

  • B432360CASSET00220 ()


  • Robotic surgical navigation system application software
360CAS Accessories Set - Dual Camera
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-SET-0011
In Commercial Distribution

  • B432360CASSET00110 ()


  • Robotic surgical navigation system application software
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