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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ENDOVUE, 24", AMERICAS, JAPAN, EMEA, BC-WU24-N1418
Nds Surgical Imaging LLC
90K0076
Not in Commercial Distribution

  • 00818089022956 ()


  • Image display unit, colour
ENDOVUE, 21", AMERICAS, JAPAN, EMEA, BC-WU21-N1418
Nds Surgical Imaging LLC
90K0066
Not in Commercial Distribution

  • 00818089022949 ()


  • Image display unit, colour
ACMF JAPAN A PACK BLUE 25
O&M HALYARD, INC.
77509
In Commercial Distribution

  • 20680651775096 ()
  • 30680651775093 ()


  • General surgical procedure kit, non-medicated, single-use
PlasmaJet V3 Plus Console System (Japan)
PLASMA SURGICAL, INC
PS10-2130-JP
In Commercial Distribution

  • M397PS102130JP0 ()
PS10-2130-JP

  • Plasma surgical system
Digitest™ II Digital Pulptester (Japan)
PARKELL, INC.
D640E-JM
In Commercial Distribution

  • 00810000520657 ()
D640E-JM

  • Dental pulp analysis system
Universal Base, Japan Implant Case Small
Nuvasive, Inc.
7241004
In Commercial Distribution

  • 00887517061522 ()


  • Device sterilization/disinfection container, reusable
4000 RESPIRATORY MONITOR COPD-6 JAPAN HI-CHECKER
VITALOGRAPH (IRELAND) LIMITED
4000
In Commercial Distribution

  • 05099169402638 ()
  • 15099169402635 ()
  • 35099169402639 ()


  • Expiratory peak flow meter, digital
PASCAL Synthesis (577), Yellow, PA-04, JAPAN (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 577- PA04
In Commercial Distribution

  • 00855005006287 ()

  • 577nm
SA-06457

  • Ophthalmic solid-state laser system, photodisruption
PASCAL Synthesis (532), Green, PA-04, JAPAN (PACKED)
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 532- PA04
In Commercial Distribution

  • 00855005006270 ()

  • 532nm
SA-06456

  • Ophthalmic solid-state laser system, photodisruption
Applications Platform 4.0 NA/JAPAN 2-Room- 119407-000
IMRIS Imaging, Inc.
Application Platform 4.0 2-Room
In Commercial Distribution

  • 00857534006493 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system
JAPAN 18G X 1.5 RB HYPO NEEDLE
MEDLINE INDUSTRIES, INC.
SAMPCJ001
In Commercial Distribution

  • 10195327614676 ()
SAMPCJ001

  • General surgical procedure kit, non-medicated, single-use
JAPAN 20G X 1 RB HYPO NEEDLE
MEDLINE INDUSTRIES, INC.
SAMPCJ002
In Commercial Distribution

  • 10195327614775 ()
SAMPCJ002

  • General surgical procedure kit, non-medicated, single-use
Precision Systems OSMETTE XL osmometer, 105VAC, Japan
Precision Systems, Inc.
5007J
In Commercial Distribution

  • 00850041049199 ()
5007J

  • Osmometric analyser IVD
V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
Respironics California, Inc.
1076709
In Commercial Distribution

  • 00884838033832 ()
1076709

  • Portable electric ventilator
ASSY, LTV1150, W/ ACC, GREY BTS, JAPAN
Carefusion Corporation
27552-006
Not in Commercial Distribution

  • 00845873004911 ()


  • Transport electric ventilator
ASSYM LTV1200, W/ ACC, GREY BTS, JAPAN
Carefusion Corporation
27553-006
Not in Commercial Distribution

  • 00845873004904 ()


  • Transport electric ventilator
FINAL ASSEMBLY, SPARK™ TRUCOLOR, TTL, JAPAN
METREX RESEARCH, LLC
910174-11
In Commercial Distribution

  • 00615375013250 ()


  • Surgical binoculars, reusable
MTO 6 LINE BOSTON SCIENTIFIC JAPAN PG
MEDLINE INDUSTRIES, INC.
62617001
In Commercial Distribution

  • 20193489057840 ()
  • 10193489057843 ()
62617001

  • Angiography kit
REMstar Auto A-Flex with SD Card, Japan
Respironics, Inc.
REMstar Auto A-Flex W/SD Card JP
Not in Commercial Distribution

  • 00606959030923 ()
JP566S

  • Home CPAP unit
EasyLife Mask with Headgear, Medium Wide, Japan
Respironics, Inc.
EasyLife Mask w/Headgear, Medium Wide, Japan
Not in Commercial Distribution

  • 00606959027862 ()
1050043

  • CPAP/BPAP nasal mask, reusable
SPEC 3 LED Japan Plug Type AJ
COLTENE/WHALEDENT INC
60013945
In Commercial Distribution

  • D661600139450 ()


  • Dental/surgical polymerization lamp
FitLife Mask with Headgear, Extra Large, Japan
Respironics, Inc.
FitLife Mask with Headgear, Extra Large, Japan
Not in Commercial Distribution

  • 00606959023048 ()
1089996

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

  • 00606959008977 ()
1104925

  • CPAP/BPAP nasal mask, reusable
DreamStation Go Auto CPAP with Bluetooth, Japan
Respironics, Inc.
DreamStation Go Auto CPAP with Bluetooth, JP
Not in Commercial Distribution

  • 00606959048706 ()
JPG500S16

  • Home CPAP unit
DreamStation BiPAP autoSV with cellular modem, Japan
Respironics, Inc.
DreamStation BiPAP autoSV W/Cell, JP
Not in Commercial Distribution

  • 00606959045415 ()
JPX900S16C

  • Portable electric ventilator
ComfortGel Blue Full Mask, Extra Large, Japan
Respironics, Inc.
ComfortGel Blue Full Mask, Extra Large, Japan
Not in Commercial Distribution

  • 00606959043909 ()
1081843

  • CPAP/BPAP face mask, reusable
BiPAP A40 Silver Series FGD SA, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959042797 ()
1109601

  • Portable electric ventilator
Nuance Gel Pillows Mask with headgear, Japan
Respironics, Inc.
Nuance Gel Pillows Mask with headgear, Japan
Not in Commercial Distribution

  • 00606959041905 ()
1105162

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

  • 30606959041623 ()
  • 00606959041622 ()
1130560

  • CPAP/BPAP nasal mask, single-use
PN841 Mask, Child Med, Leak 3, Japan
Respironics, Inc.
PN841 Mask, JPN, Child Med, Leak 3, ASM
In Commercial Distribution

  • 30606959041616 ()
  • 00606959041615 ()
1130558

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

  • 30606959041609 ()
  • 00606959041608 ()
1130496

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

  • 00606959041592 ()
1130572

  • CPAP/BPAP nasal mask, single-use
A Series System One Heated Humidifier, Japan
Respironics, Inc.
A Series System One Heated Humidifier, JP
Not in Commercial Distribution

  • 00606959041028 ()
1111553

  • Heated respiratory humidifier
Alice PDx Core System, without Sensors, Japan
Respironics, Inc.
Alice PDx Core System without Sensors, JP
Not in Commercial Distribution

  • 00606959039032 ()
1058373

  • Polysomnograph
Alice PDx Portable Sleep Diagnostic System, Japan
Respironics, Inc.
Alice PDx Sleep Diagnostic System, JP
Not in Commercial Distribution

  • 00606959038813 ()
1047990

  • Polysomnograph
BiPAP Hybrid A30 Ventilator with Humidifier, Japan
Respironics, Inc.
BiPAP Hybrid A30 Ventilator with Humidifier, Japan
Not in Commercial Distribution

  • 00606959038127 ()
1111182

  • Portable electric ventilator
BiPAP A Series, System One Humidifier, Japan
Respironics, Inc.
BiPAP A Series, System One Humidifier, JP
Not in Commercial Distribution

  • 00606959032057 ()
1111515

  • Heated respiratory humidifier
BiPAP Auto BiFlex, with SD Card, Japan
Respironics, Inc.
BiPAP Auto BiFlex, System One 60 Series, JP
Not in Commercial Distribution

  • 00606959031869 ()
JP766S

  • Home BPAP unit
XDURA CURETTE DE GRACEY #13-14 JAPAN BLADE
NORDENT MANUFACTURING INC
CENSGR13-14J
In Commercial Distribution

  • 00840018657182 ()


  • Periodontal curette
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
PlasmaJet Ultra Plus Console System In-Service (Japan)
PLASMA SURGICAL, INC
PS10-3130IS-JP
In Commercial Distribution

  • M397PS103130ISJP0 ()
PS10-3130IS-JP

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

  • 00818089022963 ()


  • Image display unit, colour
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
TSK STERiJECT Premium Disposable Hypodermic Needle
TSK LABORATORY, JAPAN
HPC-25025A
In Commercial Distribution

  • 24580708061805 ()
  • 14580708061808 ()
  • 04571225313672 ()

  • Outer Diameter: 0.5 Millimeter
  • Length: 25 Millimeter


  • Hypodermic needle, single-use
TSK STERiJECT Premium Disposable Hypodermic Needle
TSK LABORATORY, JAPAN
LDS-30013I
In Commercial Distribution

  • 24571225315991 ()
  • 14571225315994 ()
  • 34571225315998 ()
  • 04571225315997 ()

  • Outer Diameter: 0.3 Millimeter
  • Length: 13 Millimeter


  • Hypodermic needle, single-use
TSK STERiJECT Premium Disposable Hypodermic Needle
TSK LABORATORY, JAPAN
HPC-30013I
In Commercial Distribution

  • 24571225314215 ()
  • 14571225314218 ()
  • 34571225314212 ()
  • 04571225314211 ()

  • Outer Diameter: 0.3 Millimeter
  • Length: 13 Millimeter


  • Hypodermic needle, single-use
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