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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Universal Lamina Spreader - Japan
Nuvasive, Inc.
7175026
In Commercial Distribution

  • 00887517913357 ()


  • Bone distraction forceps
'CO2RE System, Packaged (Japan)
SYNERON MEDICAL LTD
FG70412JP
Not in Commercial Distribution

  • 07290109952765 ()
FG70412JP

  • Dermatological carbon dioxide laser system
FEMORAL HEAD IMPACTOR (JAPAN)
Smith & Nephew, Inc.
71362806
In Commercial Distribution

  • 00885556025147 ()
71362806

  • Orthopaedic implant impactor, reusable
TANDEM TRAY 26MM JAPAN
Smith & Nephew, Inc.
71362616
In Commercial Distribution

  • 00885556025086 ()
71362616

  • Instrument tray, reusable
Cordset USA (Japan) 3m
RADLEY SCIENTIFIC LIMITED
Series 1
In Commercial Distribution

  • 05060634770958 ()

  • Length: 3 Meter
MPC-US

  • Hard/soft-tissue ultrasonic surgical system
NIVO Pro-X Controller Kit -JAPAN
AEROGEN LIMITED
1082698
Not in Commercial Distribution

  • 05391517933574 ()


  • Benchtop nebulizer, non-heated
LBS STYLUS ASSEMBLY FOR JAPAN
Exactech, Inc.
207-60-07
In Commercial Distribution

  • 10885862053176 ()
207-60-07

  • Knee arthroplasty force sensor balance kit
Precision Flow Plus UKIT, Japan
VAPOTHERM, INC.
PLUS-UKIT-C-JP
In Commercial Distribution

  • 00841737102915 ()


  • Respiratory oxygen sensor
  • Electrical mains power cable
Precision Flow HiVNI UKIT, Japan
VAPOTHERM, INC.
HiVNI-UKIT-JP
In Commercial Distribution

  • 00841737102588 ()


  • Respiratory oxygen sensor
  • Electrical mains power cable
Precision Flow Startup Kit, Japan
VAPOTHERM, INC.
PF-UKIT-JP
In Commercial Distribution

  • 00841737101062 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
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