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

  • 00840018611573 ()


  • Periodontal curette
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
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
3DHD CAMERA HEAD AND CABLE, PANASONIC HD , JAPAN
INTUITIVE SURGICAL, INC.
380628
In Commercial Distribution

  • 00886874110706 ()


  • Electrical-only medical device connection cable, reusable
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
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
989606735041
In Commercial Distribution

  • 00884838111752 ()


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

  • 00884838111875 ()


  • General-purpose ultrasound imaging system
No Description
Terumo Cardiovascular Systems Corporation
LH130J
In Commercial Distribution

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


  • Cardiopulmonary bypass system valve, unidirectional flow/pressure control
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
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
SET,PKG,150ML FASTURN,RAD,JAPAN,MC,JA2 (85232878)
BAYER MEDICAL CARE INC.
150-FT
In Commercial Distribution

  • 40616258009931 ()
  • 00616258009933 ()
150-FT

  • Angiographic syringe
AMARA MASK WITH RS FRAME AND HEADGEAR, LARGE, JAPAN
Respironics, Inc.
AMARA MASK with RS FRAME and RS Headgear, Large, Japan
Not in Commercial Distribution

  • 00606959025097 ()
1090246

  • CPAP/BPAP face mask, reusable
AMARA MASK WITH RS FRAME AND HEADGEAR, MEDIUM, JAPAN
Respironics, Inc.
AMARA MASK with RS FRAME AND Headgear, Medium, Japan
Not in Commercial Distribution

  • 00606959025080 ()
1090245

  • CPAP/BPAP face mask, reusable
FitLife Mask with Headgear, with Standard Elbow, Large, Japan
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Large, Japan
Not in Commercial Distribution

  • 00606959023093 ()
1061714

  • CPAP/BPAP face mask, reusable
FitLife Mask with Headgear, with Standard Elbow, Small, Japan
Respironics, Inc.
FitLife Mask with Headgear, w/SE, Small, Japan
In Commercial Distribution

  • 00606959023086 ()
1061713

  • CPAP/BPAP face mask, reusable
PerforMax with Entrainment Elbow, Single Patient Use, Japan, Small
Respironics, Inc.
PerforMax Mask with EE, Single Patient Use, Small, JP
In Commercial Distribution

  • 30606959011848 ()
  • 00606959011847 ()
1055000

  • CPAP/BPAP face mask, single-use
ComfortGel Blue Full Mask w/Standard Elbow, Large, Japan
Respironics, Inc.
ComfortGel Blue Full Mask w/SE, Large, Japan
Not in Commercial Distribution

  • 00606959043930 ()
1081852

  • CPAP/BPAP face mask, reusable
PN841 Mask, Child Large, Leak 3, Single Use, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Large, Leak 3, Single Use
In Commercial Distribution

  • 00606959041561 ()
1130569

  • CPAP/BPAP nasal mask, single-use
PN841 Mask, Child Med, Leak 3, Single Use, japan
Respironics, Inc.
PN841 Mask, JPN, Child Med, Leak 3, Single Use
Not in Commercial Distribution

  • 00606959041554 ()
1130568

  • CPAP/BPAP nasal mask, single-use
PN841 Mask, Child Small, Leak 3, Single Use, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Small, Leak 3, Single Use
Not in Commercial Distribution

  • 00606959041547 ()
1130567

  • CPAP/BPAP nasal mask, single-use
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