SEARCH RESULTS FOR: ("Japan enterprise-signed app-TG:@crmeb8🆑testflight-signed app.dcf")(774 results)

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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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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
Precision Systems OSMETTE XL osmometer, 105VAC, Japan, special
Precision Systems, Inc.
5007JS
In Commercial Distribution

  • 00850041049243 ()
5007JS

  • Osmometric analyser IVD
JAPAN 25G X 5/8 RB HYPO NEEDLE
MEDLINE INDUSTRIES, INC.
SAMPCJ003
In Commercial Distribution

  • 10195327615857 ()
SAMPCJ003

  • General surgical procedure kit, non-medicated, single-use
Amara View Mask with Headgear, Extra Small, Japan
Respironics, Inc.
Amara View Mask with Headgear, XS , JP
Not in Commercial Distribution

  • 00606959024748 ()
1090641

  • CPAP/BPAP face mask, reusable
PerforMax Mask with Standard Elbow, Disposable, Japan, Large
Respironics, Inc.
PerforMax Mask, SE, Disposable, Japan, Large
In Commercial Distribution

  • 30606959011879 ()
  • 00606959011878 ()
1055003

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

  • 00606959008984 ()
1104926

  • CPAP/BPAP nasal mask, reusable
Pico nasal Mask with RS Headgear, Japan, Small-Medium
Respironics, Inc.
PICO NASAL MASK W/ RS Headgear, Small-Medium, JP
Not in Commercial Distribution

  • 00606959008960 ()
1104924

  • CPAP/BPAP nasal mask, reusable
Paralleling guide Japan modell Pin dia. 1,90 mm
Kohler Medizintechnik GmbH
8187
In Commercial Distribution

  • 04251436929489 ()
8187

  • Facebow
ComfortGel Blue Full Mask with SE, Small, Japan
Respironics, Inc.
ComfortGel Blue Full Mask with SE, Small, Japan
Not in Commercial Distribution

  • 00606959043916 ()
1081850

  • CPAP/BPAP face mask, reusable
ComfortGel Blue Nasal Mask w/Headgear, Petite, Japan
Respironics, Inc.
ComfortGel Blue Nasal Mask w/Headgear, Petite, Japan
Not in Commercial Distribution

  • 00606959043763 ()
1070085

  • CPAP/BPAP nasal mask, reusable
ComfortGel Blue Nasal Mask w/Headgear, Small, Japan
Respironics, Inc.
ComfortGel Blue Nasal Mask w/Headgear, Small, Japan
Not in Commercial Distribution

  • 00606959043756 ()
1070084

  • CPAP/BPAP nasal mask, reusable
ComfortGel Blue Nasal Mask w/Headgear, Medium, Japan
Respironics, Inc.
ComfortGel Blue Nasal Mask w/Headgear, Medium, Japan
Not in Commercial Distribution

  • 00606959043749 ()
1070083

  • CPAP/BPAP nasal mask, reusable
ComfortGel Blue Nasal Mask w/Headgear, Large, Japan
Respironics, Inc.
ComfortGel Blue Nasal Mask w/Headgear, Large, Japan
Not in Commercial Distribution

  • 00606959043732 ()
1070082

  • CPAP/BPAP nasal mask, reusable
Nuance Pro Gel Pillows Mask with headgear, Japan
Respironics, Inc.
Nuance Pro Gel Pillows Mask with headgear, Japan
Not in Commercial Distribution

  • 00606959041868 ()
1105169

  • CPAP/BPAP nasal mask, reusable
PN841 Mask with Standard Elbow, Child Large, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Large, SE, ASM
In Commercial Distribution

  • 30606959041654 ()
  • 00606959041653 ()
1130566

  • CPAP/BPAP nasal mask, single-use
PN841 Mask with Standard Elbow, Child Med, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Med, SE, ASM
In Commercial Distribution

  • 30606959041647 ()
  • 00606959041646 ()
1130564

  • CPAP/BPAP nasal mask, single-use
PN841 Mask with Standard Elbow, Child Small, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Small, SE, ASM
In Commercial Distribution

  • 30606959041630 ()
  • 00606959041639 ()
1130562

  • CPAP/BPAP nasal mask, single-use
A Series System One Heated Tube Humidifier, Japan
Respironics, Inc.
A Series System One Heated Tube Humidifier, Japan
In Commercial Distribution

  • 00606959041035 ()
1111556

  • Heated respiratory humidifier
BiPAP A40 Ventilatory Support System Silver Series, Japan
Respironics, Inc.
BiPAP A40 Silver Series Ventilator, JP
Not in Commercial Distribution

  • 00606959039544 ()
1111177

  • Portable electric ventilator
BiPAP autoSV Advanced System One 60 Series, Japan
Respironics, Inc.
BiPAP autoSV Advanced System One, 60 Series, JP
Not in Commercial Distribution

  • 00606959038202 ()
966P

  • Portable electric ventilator
Li Ion Battery, Ventilation, rechargable battery pack, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959033344 ()
1126945

  • Portable/mobile rechargeable battery pack
System One Heated Humidifier with Tube Assembly, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959032125 ()
JP6TFLG

  • Heated respiratory humidifier
BiPAP A Series, System One Heated Humidifier, Japan
Respironics, Inc.
BiPAP A Series, System One Heated Humidifier, JP
Not in Commercial Distribution

  • 00606959032064 ()
1111548

  • Heated respiratory humidifier
REMstar Pro C-Flex+, System One 60 Series, Japan
Respironics, Inc.
REMstar Pro C-Flex+, System One 60Series, JP
Not in Commercial Distribution

  • 00606959030466 ()
JP466S

  • Home CPAP unit
BiPAP autoSV Advanced System One 60 Series, Japan
Respironics, Inc.
BiPAP autoSV Advanced, 60 Series, JP
Not in Commercial Distribution

  • 00606959029743 ()
JP966S

  • Portable electric ventilator
OmniLab Advanced Plus with Heated Tube Humidifier, Japan
Respironics, Inc.
OmniLab Advanced Plus w/H Tube Humid, JP
Not in Commercial Distribution

  • 00606959029460 ()
1111140

  • Portable electric ventilator
PTRAK FULL FACE MASK WITH CAPSTRAP, SMALL, JAPAN
Respironics, Inc.
PERFORMATRAK FULL FACE MASK W CAPSTRAP,JP, SMALL
Not in Commercial Distribution

  • 30606959028372 ()
  • 00606959028371 ()
1126371

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL FACE MASK WITH CAPSTRAP, MEDIUM, JAPAN
Respironics, Inc.
PERFORMATRAK FULL FACE MASK W CAPSTRAP,JPN, MEDIUM
Not in Commercial Distribution

  • 30606959028358 ()
  • 00606959028357 ()
1126369

  • CPAP/BPAP face mask, single-use
PERFORMATRAK FULL FACE MASK WITH CAPSTRAP, LARGE, JAPAN
Respironics, Inc.
PERFORMATRAK FULL FACE MASK W CAPSTRAP,JPN, LARGE
Not in Commercial Distribution

  • 30606959028334 ()
  • 00606959028333 ()
1126287

  • CPAP/BPAP face mask, single-use
DreamWear SC Under the Nose Mask Fitpack Japan
Respironics, Inc.
DreamWear SC Under Nose Mask Fitpack Japan
Not in Commercial Distribution

  • 00606959052291 ()
1138670

  • CPAP/BPAP nasal mask, reusable
DreamWear Gel Pillow, Large Frame with Headgear, Japan
Respironics, Inc.
DreamWear Gel Pillows Mask, Large Frame w/Hgr, JP
Not in Commercial Distribution

  • 00606959048492 ()
1135049

  • CPAP/BPAP nasal mask, reusable
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