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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XDURA CURETTE DE GRACEY #11-12 JAPAN BLADE
NORDENT MANUFACTURING INC
CENSGR11-12J
In Commercial Distribution

  • 00840018657175 ()


  • Periodontal curette
XDURA CURETTE DE GRACEY #1-2 JAPAN BLADE
NORDENT MANUFACTURING INC
CENSGR1-2J
In Commercial Distribution

  • 00840018657168 ()


  • Periodontal curette
EndoVue Plus 4K, America, Japan, EMEA, BC-WK32-A1B00
Nds Surgical Imaging LLC
90K0101
In Commercial Distribution

  • 00818089022963 ()


  • Image display unit, colour
303945-JA12 Accessory Kit, Med4 Elite, Japan, JP
Avanos Medical, Inc.
303945-JA12
In Commercial Distribution

  • 00812120003799 ()
303945-JA12

  • Circulating-fluid localized thermal/compression therapy system wrap
Power Cord, Med4 Elite, JIS 8303 JAPAN
Avanos Medical, Inc.
303846
In Commercial Distribution

  • 00812120002600 ()


  • Circulating-fluid localized thermal/compression therapy system control unit
PlasmaJet Ultra Plus Console System In-Service (Japan)
PLASMA SURGICAL, INC
PS10-3130IS-JP
In Commercial Distribution

  • M397PS103130ISJP0 ()
PS10-3130IS-JP

  • Plasma surgical system
PlasmaJet V3 Plus Console System In-Service (Japan)
PLASMA SURGICAL, INC
PS10-2130IS-JP
In Commercial Distribution

  • M397PS102130ISJP0 ()
PS10-2130IS-JP

  • Plasma surgical system
ENS 97725 WIRELESS PAIN US JAPAN DEVICE
MEDTRONIC, INC.
97725
In Commercial Distribution

  • 00763000017590 ()


  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
PASCAL Synthesis TwinStar (577/638), PA-04, JAPAN (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis TwinStar (577/638)- PA04
In Commercial Distribution

  • 00855005006263 ()

  • 577nm and 638nm
SA-06453

  • Ophthalmic solid-state laser system, photodisruption
HipAlign Inst. Set – Japan DAA/Supine: Cup Only
Orthalign, Inc.
403007-12
In Commercial Distribution

  • 00851977007826 ()
403007-12

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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