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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FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, JAPAN w/SOFT CASE
METREX RESEARCH, LLC
910174-12
In Commercial Distribution

  • 00615375013267 ()


  • Surgical binoculars, reusable
JAPAN REDUCED KEEL INSTRUMENTATION #3/#4 PRESS FIT TIBIAL PUNCH
Howmedica Osteonics Corp.
3760-0304
In Commercial Distribution

  • 07613327222647 ()

  • Size: 3
3760-0304

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RADIANCE G2 24", W/O FIBER, CUSTOM FUJIFILM JAPAN, SC-WU24-A1511
Nds Surgical Imaging LLC
90X0640
In Commercial Distribution

  • 00818089021058 ()


  • Image display unit, colour
EndoVue Plus 4K 32”, Quad-link SDI, America, Japan, EMEA, BC-WK32-A1B20
Nds Surgical Imaging LLC
90K0102
Not in Commercial Distribution

  • 00818089022970 ()


  • Image display unit, colour
Extracorporeal ultrasound imaging system transducer, hand-held
ECHONOUS, INC.
R003994
In Commercial Distribution

  • 09353278000403 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Quick Pressure Monitor set (6/pk Chamber and side ported needle)
C2DX, INC.
0295-002-000J
In Commercial Distribution

  • 00850007350024 ()
  • 10850007350021 ()


  • Compartmental-pressure monitoring system, single-use
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5803J
In Commercial Distribution

  • 00842430107016 ()
5803J

  • Electromechanical operating table base
Delivery System Assembly
Candela Corporation
0800-00-1095
Not in Commercial Distribution

  • 00817495021782 ()


  • Dermatological laser beam producing handpiece
3M™ Surgical Clipper Charger Stand, US/Japan Type A, 9662L
3M COMPANY
9662L
In Commercial Distribution

  • 00707387772161 ()
9662L

  • Surgical hair clippers
ISolate® Stock Solution Custom packaging configuration. Only distributed in Japan.
FUJIFILM IRVINE SCIENTIFIC, INC.
99275-12x6ML
In Commercial Distribution

  • 00857515006269 ()
  • 18575150062691 ()

  • Total Volume: 6 Milliliter
99275

  • IVF medium
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