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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CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external
Vea - Mobile Alignment App
ALPHATEC SPINE, INC.
AIX21000
In Commercial Distribution

  • 00190376470351 ()


  • Orthopaedic/craniofacial implantation planning software
MYAIR FOR IOS APP
RESMED CORP.
22245
In Commercial Distribution

  • 00840193400115 ()
22245

  • Self-care monitoring/reporting software
Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit
In Commercial Distribution

  • 03770014642660 ()


  • Pelvic floor muscle exerciser
Kegel Exerciser with App
X6 INNOVATIONS
Pink Perifit
In Commercial Distribution

  • 03770014642448 ()


  • Pelvic floor muscle exerciser
Kegel Exerciser with App
X6 INNOVATIONS
Purple Perifit Care+
In Commercial Distribution

  • 03770014642196 ()


  • Pelvic floor muscle exerciser
Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit Care
In Commercial Distribution

  • 03770014642165 ()


  • Pelvic floor muscle exerciser
Kegel Exerciser with App
X6 INNOVATIONS
Pink Perifit Care
In Commercial Distribution

  • 03770014642134 ()


  • Pelvic floor muscle exerciser
BARIATRIC APP PAD ONLY
COMPASS HEALTH BRANDS CORP.
1105
In Commercial Distribution

  • 30815067042563 ()
  • 00815067042562 ()


  • Alternating-pressure bed mattress overlay, reusable
APP SYSTEM AIR ADJUSTABLE
COMPASS HEALTH BRANDS CORP.
1003
In Commercial Distribution

  • 30815067040163 ()
  • 00815067040162 ()


  • Alternating-pressure bed mattress overlay system
Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution

  • 10385083000565 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution

  • 10385083000336 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
DS Replacement APP Pump,
COMPASS HEALTH BRANDS CORP.
DS-NADJP
In Commercial Distribution

  • 30092237617947 ()
  • 00092237617946 ()


  • Alternating-pressure inflator
APP replacement pad, deluxe
COMPASS HEALTH BRANDS CORP.
APP-DLXP
In Commercial Distribution

  • 80092237602054 ()
  • 00092237602058 ()


  • Alternating-pressure bed mattress overlay, reusable
APP Replacement pad, basic
COMPASS HEALTH BRANDS CORP.
APP-BPD
In Commercial Distribution

  • 80092237602023 ()
  • 00092237602027 ()


  • Alternating-pressure bed mattress overlay, reusable
Easy Line remote App
Sonova AG
088-0010
In Commercial Distribution

  • 07613389310962 ()
088-0010

  • Audiometric/hearing device software
HANSATON Stream Remote App
Hansaton Akustik GmbH
088-5003
In Commercial Distribution

  • 07613389127225 ()
088-5003

  • Audiometric/hearing device software
Unitron Remote Plus app
Unitron Hearing Division
088-5001
In Commercial Distribution

  • 07613389075823 ()
088-5001

  • Audiometric/hearing device software
TC Discover App UDID
PRENTKE ROMICH COMPANY
Discover App
In Commercial Distribution

  • 00816486021367 ()
19285-9

  • Voice synthesizer/digitizer
Hearing Remote 5.0 app
Sonova AG
088-5017
In Commercial Distribution

  • 07613389610925 ()
088-5017

  • Audiometric/hearing device software
All-Day Clear 1.0 app
Sonova AG
088-5015
In Commercial Distribution

  • 07613389557930 ()
088-5015

  • Audiometric/hearing device software
Biim Android App, P2.0
Biim Ultrasound AS
P001425
In Commercial Distribution

  • 07090045490334 ()
P001425

  • Hand-held ultrasound imaging system, body-surface
  • Extracorporeal ultrasound imaging transducer, hand-held
Biim Android App, P1.3.2
Biim Ultrasound AS
P001418
In Commercial Distribution

  • 07090045490310 ()
P001418

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.3.1
Biim Ultrasound AS
P001403
In Commercial Distribution

  • 07090045490235 ()
P001403

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.3
Biim Ultrasound AS
P001228
In Commercial Distribution

  • 07090045490198 ()
P001228

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.2
Biim Ultrasound AS
P001158
In Commercial Distribution

  • 07090045490150 ()
P001158

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.2
Biim Ultrasound AS
P001157
In Commercial Distribution

  • 07090045490143 ()
P001157

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim Android App, P1.1
Biim Ultrasound AS
P001118
In Commercial Distribution

  • 07090045490020 ()
P001118

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.1
Biim Ultrasound AS
P001117
In Commercial Distribution

  • 07090045490013 ()
P001117

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P2.0
Biim Ultrasound AS
P001424
In Commercial Distribution

  • 07090045490327 ()
P001424

  • Hand-held ultrasound imaging system, body-surface
  • Extracorporeal ultrasound imaging transducer, hand-held
Biim iOS App, P1.3.2
Biim Ultrasound AS
P001417
In Commercial Distribution

  • 07090045490303 ()
P001417

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.3.1
Biim Ultrasound AS
P001402
In Commercial Distribution

  • 07090045490228 ()
P001402

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
Biim iOS App, P1.3
Biim Ultrasound AS
P001227
In Commercial Distribution

  • 07090045490181 ()
P001227

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
No Description
TECHNO-PATH MANUFACTURING LIMITED
09339876190
In Commercial Distribution

  • 05391523442060 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
09339868190
In Commercial Distribution

  • 05391523442053 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
08P89-10
In Commercial Distribution

  • 05391523440752 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
UC202A.10
In Commercial Distribution

  • 05391523440424 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
UC201A.10
In Commercial Distribution

  • 05391523440417 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
UC20BX
Not in Commercial Distribution

  • 05391523440400 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
UC202X
In Commercial Distribution

  • 05391523440394 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
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