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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Actiwatch Spectrum PRO Japan
Respironics, Inc.
Actiwatch Spectrum PRO Japan
Not in Commercial Distribution

  • 00606959042032 ()
JP1099351

  • Kinesiology ambulatory recorder
OmniLab Advanced Plus, Japan
Respironics, Inc.
OmniLab Advanced Plus, JP
Not in Commercial Distribution

  • 00606959032040 ()
1109585

  • Portable electric ventilator
OmniLab Advanced Plus, Japan
Respironics, Inc.
OmniLab Advanced Plus, JP
Not in Commercial Distribution

  • 00606959029446 ()
1111138

  • Portable electric ventilator
DreamStation Auto BiPAP, Japan
Respironics, Inc.
DreamStation Auto BiPAP, JP
Not in Commercial Distribution

  • 00606959028272 ()
JPX700S16

  • Home BPAP unit
DreamStation Auto CPAP, Japan
Respironics, Inc.
DreamStation Auto CPAP, JP
Not in Commercial Distribution

  • 00606959028265 ()
JPX500S16

  • Home CPAP unit
DreamStation CPAP Pro, Japan
Respironics, Inc.
DreamStation CPAP Pro, JP
In Commercial Distribution

  • 00606959028258 ()
JPX400S16

  • Home CPAP unit
Broadband Oximetry Accessory, Japan
Respironics, Inc.
Broadband/Oximetry Accessory, JP
Not in Commercial Distribution

  • 00606959028197 ()
100225E

  • Clinical laboratory information system
Trilogy Evo, O2, Japan
Respironics, Inc.
JP2100X16B
In Commercial Distribution

  • 00606959055582 ()
JP2100X16B

  • Portable electric ventilator
COMPUTERIZED SPEECH LAB (JAPAN)
PENTAX OF AMERICA, INC.
4500-JP
In Commercial Distribution

  • 04961333244638 ()


  • Electroglottograph
CO2RE System, Packaged (Japan)
Candela Corporation
FG70412JP
In Commercial Distribution

FG70412JP

  • Dermatological carbon dioxide laser system
'CO2RE System, Packaged (Japan)
SYNERON MEDICAL LTD
FG70412JP
Not in Commercial Distribution

  • 07290109952765 ()
FG70412JP

  • Dermatological carbon dioxide laser system
Universal Lamina Spreader - Japan
Nuvasive, Inc.
7175026
In Commercial Distribution

  • 00887517913357 ()


  • Bone distraction forceps
FEMORAL HEAD IMPACTOR (JAPAN)
Smith & Nephew, Inc.
71362806
In Commercial Distribution

  • 00885556025147 ()
71362806

  • Orthopaedic implant impactor, reusable
TANDEM TRAY 26MM JAPAN
Smith & Nephew, Inc.
71362616
In Commercial Distribution

  • 00885556025086 ()
71362616

  • Instrument tray, reusable
Cordset USA (Japan) 3m
RADLEY SCIENTIFIC LIMITED
Series 1
In Commercial Distribution

  • 05060634770958 ()

  • Length: 3 Meter
MPC-US

  • Hard/soft-tissue ultrasonic surgical system
NIVO Pro-X Controller Kit -JAPAN
AEROGEN LIMITED
1082698
Not in Commercial Distribution

  • 05391517933574 ()


  • Benchtop nebulizer, non-heated
ASSY, LTV1150, W/ ACCESS, JAPAN
Carefusion Corporation
18984-006
Not in Commercial Distribution

  • 00845873002740 ()


  • Transport electric ventilator
ASSY, LTV1200, W/ ACCESS, JAPAN
Carefusion Corporation
18888-006
Not in Commercial Distribution

  • 00845873002641 ()


  • Transport electric ventilator
Trilogy O2 Ventilator, Rental, Japan
Respironics, Inc.
Trilogy O2 Ventilator, Japan, Rental
Not in Commercial Distribution

  • 00606959033887 ()
R1040004

  • Portable electric ventilator
Japan Clamp, Shoulder Suspension System
ALLEN MEDICAL SYSTEMS, INC.
AR-1650-11
In Commercial Distribution

  • 00615521004620 ()


  • Operating table traction frame
Allen Advanced Arm Support - Japan
HILL-ROM, INC.
107002
In Commercial Distribution

  • 00615521002671 ()
A-70615-JP

  • Arm procedure positioner, reusable
Trilogy O2 Ventilator, Recertified, Japan
Respironics, Inc.
Trilogy O2 Ventilator,Japan-RECERT
Not in Commercial Distribution

  • 00606959033948 ()
U1040004

  • Portable electric ventilator
Trilogy 100 Ventilator, Japan, Rental
Respironics, Inc.
00
In Commercial Distribution

  • 00606959033894 ()
R1054655

  • Portable electric ventilator
Sleepware G3 Software Package, Japan
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959038943 ()
1121998

  • Polysomnography analyser
BiPAP Hybrid A30 Ventilator, Japan
Respironics, Inc.
BiPAP Hybrid A30 Ventilator, Japan
Not in Commercial Distribution

  • 00606959038110 ()
1111181

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

  • 00606959032101 ()
JP6HFLG

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

  • 00606959029248 ()
JP6H

  • Heated respiratory humidifier
Software, Sleepware G3 (Japan Only)
Respironics, Inc.
Sleepware G3 Software, (Japan Only) - 3
Not in Commercial Distribution

  • 00606959046955 ()
1121998

  • Polysomnography analyser
Trilogy 200 Ventilator, Bluetooth, Japan
Respironics, Inc.
Trilogy 200 Ventilator, Bluetooth, Japan
Not in Commercial Distribution

  • 00606959052352 ()
1032804B

  • Portable electric ventilator
DreamStation Auto CPAP, 12mm, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959061316 ()
JPX501S16

  • Home CPAP unit
Precision Flow Plus UKIT, Japan
VAPOTHERM, INC.
PLUS-UKIT-C-JP
In Commercial Distribution

  • 00841737102915 ()


  • Respiratory oxygen sensor
  • Electrical mains power cable
Precision Flow HiVNI UKIT, Japan
VAPOTHERM, INC.
HiVNI-UKIT-JP
In Commercial Distribution

  • 00841737102588 ()


  • Respiratory oxygen sensor
  • Electrical mains power cable
Precision Flow Startup Kit, Japan
VAPOTHERM, INC.
PF-UKIT-JP
In Commercial Distribution

  • 00841737101062 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
3300HJR,CHAMBER ASSEMBLY,JAPAN,REVERSE
SECHRIST INDUSTRIES, INC.
3300HJR
In Commercial Distribution

  • 00899660002529 ()

  • Weight: 2030 Pound
  • Height: 77 Inch
  • Width: 53 Inch
  • Depth: 103 Inch


  • Hyperbaric chamber, stationary
3300HJ CHAMBER ASSEMBLY, STANDARD,JAPAN
SECHRIST INDUSTRIES, INC.
3300HJ
In Commercial Distribution

  • 00899660002512 ()

  • Depth: 103 Inch
  • Width: 53 Inch
  • Height: 77 Inch
  • Weight: 2030 Pound


  • Hyperbaric chamber, stationary
iPad Power Supply - US, Japan
ANGIODYNAMICS, INC.
MRC3S911
In Commercial Distribution

  • 15051684029797 ()
  • H787MRC3S9110 ()


  • Central venous catheter navigation system, electrocardiographic
LBS STYLUS ASSEMBLY FOR JAPAN
Exactech, Inc.
207-60-07
In Commercial Distribution

  • 10885862053176 ()
207-60-07

  • Knee arthroplasty force sensor balance kit
RESTORATION CYLINDRICAL DISTAL EXTENSION JAPAN
Howmedica Osteonics Corp.
1217-3135
In Commercial Distribution

  • 07613327211375 ()

  • Length: 175.0 Millimeter
  • Diameter: 13.5 Millimeter
1217-3135

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RESTORATION CYLINDRICAL DISTAL EXTENSION JAPAN
Howmedica Osteonics Corp.
1217-3175
In Commercial Distribution

  • 07613327211245 ()

  • Length: 175.0 Millimeter
  • Diameter: 17.5 Millimeter
1217-3175

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RESTORATION CYLINDRICAL DISTAL EXTENSION JAPAN
Howmedica Osteonics Corp.
1217-3155
In Commercial Distribution

  • 07613327211207 ()

  • Diameter: 15.5 Millimeter
  • Length: 175.0 Millimeter
1217-3155

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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