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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STRPR 1.2 APP, LINKED WH STREAMER PRO 1.2 APP CL
Oticon A/S
139350
In Commercial Distribution

  • 05707131268587 ()


  • Hearing aid neck induction loop, wireless input
STRPR 1.2 APP, LINKED BL STREAMER PRO 1.2 APP CL
Oticon A/S
138119
In Commercial Distribution

  • 05707131268518 ()


  • Hearing aid neck induction loop, wireless input
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
CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external
CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external
DS Replacement APP Pump,
COMPASS HEALTH BRANDS CORP.
DS-NADJP
In Commercial Distribution

  • 30092237617947 ()
  • 00092237617946 ()


  • Alternating-pressure inflator
Vea - Mobile Alignment App
ALPHATEC SPINE, INC.
AIX21000
In Commercial Distribution

  • 00190376470351 ()


  • Orthopaedic/craniofacial implantation planning 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
ALLENTOWN LAP CHOLE APP
Cardinal Health 200, LLC
SLC11LLSL1
In Commercial Distribution

  • 50888439303597 ()
  • 10888439303599 ()
SLC11LLSL1

  • Laparoscopic surgical procedure kit, non-medicated, single-use
Osia Smart App (Android)
COCHLEAR LIMITED
P1340354
In Commercial Distribution

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software
Osia Smart App (iOS)
COCHLEAR LIMITED
P1340352
In Commercial Distribution

  • 09321502046138 ()
P1340352

  • Audiometric/hearing device software
Nucleus Smart App, (iOS)
COCHLEAR LIMITED
P832154
In Commercial Distribution

  • 09321502036788 ()
P832154

  • Audiometric/hearing device software
Baha 5 Smart App
Cochlear Bone Anchored Solutions AB
P736025
Not in Commercial Distribution

  • 09321502034180 ()
P736025

  • Hearing aid/implant system remote control
Baha 5 Smart App
Cochlear Bone Anchored Solutions AB
95448
Not in Commercial Distribution

  • 09321502034159 ()
95448

  • Hearing aid/implant system remote control
DreamMapper App iOS (APAC)
Respironics, Inc.
DreamMapper App iOS, Asia-Pacific Instance - 2
In Commercial Distribution

  • 00606959057715 ()
1127959

  • Self-care monitoring/reporting software
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