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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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
Paralleling guide Japan modell Pin dia. 1,90 mm
Kohler Medizintechnik GmbH
8187
In Commercial Distribution

  • 04251436929489 ()
8187

  • Facebow
CURETTE, GRACEY 11-12 JAPAN BLADE, MEDIUM ROUND HANDLE
NORDENT MANUFACTURING INC
RSCGR11-12J
In Commercial Distribution

  • 00840018611573 ()


  • Periodontal curette
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
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
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
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
DreamWear Gel Pillow, Medium Frame with Headgear, Japan
Respironics, Inc.
DreamWear Gel Pillows Mask, Medium Frame w/Hgr, JP
Not in Commercial Distribution

  • 00606959048485 ()
1135048

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

  • 00606959048478 ()
1135046

  • CPAP/BPAP nasal mask, reusable
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
CATH 8711 2PC CLSD TIP JAPAN US (TRAY)
MEDTRONIC, INC.
8711
Not in Commercial Distribution

  • 00613994586032 ()


  • General-purpose implantable infusion pump, programmable
GAME READY* Med4 Elite* Accessory Kit - Japan, JP
Avanos Medical, Inc.
303945-JA12
In Commercial Distribution

  • 00812120004444 ()
303945-JA12

  • Circulating-fluid localized thermal/compression therapy system control unit
JAPAN KNEE INSTRUMENTATION #5/#6 CEMENT TIBIAL PUNCH
Howmedica Osteonics Corp.
3761-0506
In Commercial Distribution

  • 07613327222692 ()

  • Size: 6
  • Size: 5
3761-0506

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Canister HFO-R1234 ZE / 950g, ALUM, 15 Pack (Japan)
Candela Corporation
FIN101112
In Commercial Distribution

  • 00817495025025 ()
FIN101112

  • Dermatological solid-state laser system
Canister HFO-R1234 ZE / 950g, ALUM, 3 Pack (Japan)
Candela Corporation
FIN101106
In Commercial Distribution

  • 00817495024967 ()


  • Dermatological solid-state laser system
Part Number 108110-JAPAN, VTI Power Cord: Hospital Japan
VASCULAR TECHNOLOGY, INCORPORATED
108110-JAPAN
In Commercial Distribution

  • 00817122020096 ()
108110-JAPAN

  • Electrical mains power cable
3DHD CAMERA HEAD AND CABLE, PANASONIC HD , JAPAN
INTUITIVE SURGICAL, INC.
380628
In Commercial Distribution

  • 00886874110706 ()


  • Electrical-only medical device connection cable, reusable
Compact Series Ultrasound System Cart
Philips Ultrasound LLC
989606735291
In Commercial Distribution

  • 00884838112001 ()


  • General-purpose ultrasound imaging system
Compact Series Ultrasound System Cart
Philips Ultrasound LLC
989606735161
In Commercial Distribution

  • 00884838111875 ()


  • General-purpose ultrasound imaging system
Compact Series Ultrasound System Cart
Philips Ultrasound LLC
989606735041
In Commercial Distribution

  • 00884838111752 ()


  • General-purpose ultrasound imaging system
The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates a foot lift at the correct time during walking. A foot drop occurs when a person connot lift the foot on their own. This results in the foot slapping on the floor or the toes dragging during walking. The WalkAide stimulates a nerve as it passes below the knee and activates the muscles that raise the foot.The WalkAide Patient Kit includes a WalkAide Control Unit, a WalkAide cuff, and an electrode lead cable. A foot sensor is an optional item.
INNOVATIVE NEUROTRONICS, INC.
21-1000
In Commercial Distribution

  • 00858184006031 ()


  • Gait-enhancement electrical stimulation system, external
No Description
Terumo Cardiovascular Systems Corporation
MCVS550DJ
In Commercial Distribution

  • 50699753021087 ()
  • 00699753021082 ()


  • Endoscopic electrosurgical electrode, bipolar, single-use
No Description
Terumo Cardiovascular Systems Corporation
MCVS550HVJ
In Commercial Distribution

  • 50699753021070 ()
  • 00699753021075 ()


  • Endoscopic electrosurgical electrode, bipolar, single-use
No Description
Terumo Cardiovascular Systems Corporation
LH130J
In Commercial Distribution

  • 50699753450238 ()
  • 30699753450234 ()
  • 00699753450233 ()


  • Cardiopulmonary bypass system valve, unidirectional flow/pressure control
Extracorporeal ultrasound imaging system transducer, hand-held
ECHONOUS, INC.
P003994
In Commercial Distribution

  • 09369999064099 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
General ultrasound imaging system, battery-powered
ECHONOUS, INC.
R004104
In Commercial Distribution

  • 09353278000182 ()


  • Hand-held ultrasound imaging system, body-surface
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
6875J
In Commercial Distribution

  • 00842430108754 ()
6875J

  • Orthopaedic operating table, electromechanical
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