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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OmniLab Advanced Plus - 00606959029446

OmniLab Advanced Plus, Japan
Respironics, Inc.
OmniLab Advanced Plus, JP
Not in Commercial Distribution

  • 00606959029446 ()
1111138

  • Portable electric ventilator

DreamStation - 00606959028272

DreamStation Auto BiPAP, Japan
Respironics, Inc.
DreamStation Auto BiPAP, JP
Not in Commercial Distribution

  • 00606959028272 ()
JPX700S16

  • Home BPAP unit

DreamStation - 00606959028265

DreamStation Auto CPAP, Japan
Respironics, Inc.
DreamStation Auto CPAP, JP
Not in Commercial Distribution

  • 00606959028265 ()
JPX500S16

  • Home CPAP unit

DreamStation - 00606959028258

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

  • 00606959028258 ()
JPX400S16

  • Home CPAP unit

Broadband Modem - 00606959028197

Broadband Oximetry Accessory, Japan
Respironics, Inc.
Broadband/Oximetry Accessory, JP
Not in Commercial Distribution

  • 00606959028197 ()
100225E

  • Clinical laboratory information system

HUDSON RCI - 14026704728531

Conchatherm® Neptune - Japan
TELEFLEX INCORPORATED
IPN927525
In Commercial Distribution

  • 54026704728539 ()
  • 14026704728531 ()
425-40

  • Heated respiratory humidifier

PHB, Autoalert, Japan - Primary - 00884838071797

PHB, Autoalert, Japan - Primary
Lifeline Systems Company
1840501
Not in Commercial Distribution

  • 00884838071797 ()
FD100-J

  • Vulnerable patient home alert system

CO2RE System, Packaged (Japan) - 00817495024271

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

FG70412JP

  • Dermatological carbon dioxide laser system

NASOMETER II - 04961333244638

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

  • 04961333244638 ()


  • Electroglottograph

I-neb - 00383730004396

I-neb PH Unit Japan
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730004396 ()
1080086

  • Ultrasonic nebulizing system

NuVasive - 00887517913357

Universal Lamina Spreader - Japan
Nuvasive, Inc.
7175026
In Commercial Distribution

  • 00887517913357 ()


  • Bone distraction forceps

'CO2RE System, Packaged (Japan) - 07290109952765

'CO2RE System, Packaged (Japan)
SYNERON MEDICAL LTD
FG70412JP
Not in Commercial Distribution

  • 07290109952765 ()
FG70412JP

  • Dermatological carbon dioxide laser system

NA - 00885556025147

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

  • 00885556025147 ()
71362806

  • Orthopaedic implant impactor, reusable

Tandem - 00885556025086

TANDEM TRAY 26MM JAPAN
Smith & Nephew, Inc.
71362616
In Commercial Distribution

  • 00885556025086 ()
71362616

  • Instrument tray, reusable

TORS - 05060634770958

Cordset USA (Japan) 3m
RADLEY SCIENTIFIC LIMITED
Series 1
In Commercial Distribution

  • 05060634770958 ()

  • Length: 3 Meter
MPC-US

  • Hard/soft-tissue ultrasonic surgical system

Arthrex - 00615521004620

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

  • 00615521004620 ()


  • Operating table traction frame

ALLEN - 00615521002671

Allen Advanced Arm Support - Japan
HILL-ROM, INC.
107002
In Commercial Distribution

  • 00615521002671 ()
A-70615-JP

  • Arm procedure positioner, reusable

LTV - 00845873002740

ASSY, LTV1150, W/ ACCESS, JAPAN
Carefusion Corporation
18984-006
Not in Commercial Distribution

  • 00845873002740 ()


  • Transport electric ventilator

LTV - 00845873002641

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

  • 00845873002641 ()


  • Transport electric ventilator

NIVO Nebulizer System - 05391517933574

NIVO Pro-X Controller Kit -JAPAN
AEROGEN LIMITED
1082698
Not in Commercial Distribution

  • 05391517933574 ()


  • Benchtop nebulizer, non-heated
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