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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PASCAL Synthesis (577), Yellow, PA-04, JAPAN (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 577- PA04
In Commercial Distribution

  • 00855005006287 ()

  • 577nm
SA-06457

  • Ophthalmic solid-state laser system, photodisruption
PASCAL Synthesis (532), Green, PA-04, JAPAN (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 532- PA04
In Commercial Distribution

  • 00855005006270 ()

  • 532nm
SA-06456

  • Ophthalmic solid-state laser system, photodisruption
Applications Platform 4.0 NA/JAPAN 2-Room- 119407-000
IMRIS Imaging, Inc.
Application Platform 4.0 2-Room
In Commercial Distribution

  • 00857534006493 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system
Precision Systems OSMETTE XL osmometer, 105VAC, Japan
Precision Systems, Inc.
5007J
In Commercial Distribution

  • 00850041049199 ()
5007J

  • Osmometric analyser IVD
V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
Respironics California, Inc.
1076709
In Commercial Distribution

  • 00884838033832 ()
1076709

  • Portable electric ventilator
FitLife Mask with Headgear, Extra Large, Japan
Respironics, Inc.
FitLife Mask with Headgear, Extra Large, Japan
Not in Commercial Distribution

  • 00606959023048 ()
1089996

  • CPAP/BPAP face mask, reusable
Pico Nasal Mask with Headgear, Japan, Large
Respironics, Inc.
PICO NASAL MASK W/Headgear, Large, JP
Not in Commercial Distribution

  • 00606959008977 ()
1104925

  • CPAP/BPAP nasal mask, reusable
FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, JAPAN
METREX RESEARCH, LLC
910174-11
In Commercial Distribution

  • 00615375013250 ()


  • Surgical binoculars, reusable
ComfortGel Blue Full Mask, Extra Large, Japan
Respironics, Inc.
ComfortGel Blue Full Mask, Extra Large, Japan
Not in Commercial Distribution

  • 00606959043909 ()
1081843

  • CPAP/BPAP face mask, reusable
BiPAP A40 Silver Series FGD SA, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959042797 ()
1109601

  • Portable electric ventilator
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