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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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KONMED /Pelvifine - 06970935830543

This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM531
In Commercial Distribution

  • 06970935830543 ()


  • Pelvic floor exercise biofeedback device

KONMED /Pelvifine - 06970935830536

This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
Shenzhen Konmed Technology Co., Ltd.
KM530
In Commercial Distribution

  • 06970935830536 ()


  • Pelvic floor exercise biofeedback device

Miracle Ear App - 00860001471731

Also covers the following minor/medium updates: v3.1.0: (01)00860001471731(11)210526(10)310; v3.1.1 (01)00860001471731(11)210604(10)311; v3.1.2 (01)00860001471731(11)210625(10)312; v3.2.0 (01)00860001471731(11)210713(10)320; v3.2.1. (01)00860001471731(11)210804(10)321; v3.2.2 (01)00860001471731(11)210917(10)322; v3.2.3 (01)00860001471731(11)211026(10)323 ;v3.2.4 (01)00860001471731(11)211123(10)324; v3.4.0: (01)00860001471731(11)220609(10)340; v3.5.1 (01)00860001471731(11)220718(10)351; v3.6.0 (01)00860001471731(11)220926(10)360; v3.6.2(01)00860001471731(11)221024(10)362; v3.7.0(01)00860001471731(11)221116(10)370; v3.8.0(01)00860001471731(11)221215(10)380; v3.8.1(01)00860001471731(11)230127(10)381; v3.9.0(01)00860001471731(11)230217(10)390; v3.9.1(01)00860001471731(11)230417(10)391; v3.9.2 (01)00860001471731(11)230609(10)392; v3.9.3 (01)00860001471731(11)230714(10)393; v3.10.0 (01)00860001471731(11)231013(10)3100
AMPLIFON SPA
Android v3
In Commercial Distribution

  • 00860001471731 ()


  • Hearing aid/implant system remote control

Miracle Ear App - 00860001471724

Also covers the following minor/medium updates: v3.1.0 (01)00860001471724(11)210526(10)310; v3.1.1 (01)00860001471724(11)210604(10)311; v3.1.2 (01)00860001471724(11)210625(10)312; v3.2.0 (01)00860001471724(11)210713(10)320; v3.2.1. (01)00860001471724(11)210804(10)321; v3.2.2 (01)00860001471724(11)210917(10)322; v3.2.3 (01)00860001471724(11)211026(10)323 ;v3.2.4 (01)00860001471724(11)211123(10)324; v3.7.0 (01)00860001471724(11) 221116(10)370; v3.6.2 (01)00860001471724(11) 221024(10)362; v3.4.0:(01)00860001471724(11)220609(10)350; v3.5.1(01)00860001471724(11)220718(10)351; v3.6.0 (01)00860001471724(11) 220926(10)360; v3.8.0 (01)00860001471724(11) 221215(10)380; v3.8.1 (01)00860001471724(11) 230127(10)381; v3.9.0 (01)00860001471724(11) 230217(10)390; v3.9.1 (01)00860001471724(11) 230417(10)391; v3.9.2 (01)00860001471724(11) 230609(10)392; v3.9.3 (01)00860001471724(11) 230714(10)393; v3.10.0 (01)00860001471724(11) 231013(10)3100
AMPLIFON SPA
iOS v3
In Commercial Distribution

  • 00860001471724 ()


  • Hearing aid/implant system remote control

Miracle-Ear App - 00860001471717

App Android 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471717(11)190807(10)202; v2.0.3: (01)00860001471717(11)190927(10)203; v2.0.4: (01)00860001471717(11)191014(10)204; v2.0.5: (01)00860001471717(11)191218(10)205; v2.0.6: (01)00860001471717(11)200227(10)206; v2.1.0: (01)00860001471717(11)200420(10)210; v2.2.1: (01)00860001471717(11)200729(10)221; v2.3.0: (01)00860001471717(11)201217(10)230; v2.3.1: (01)00860001471717(11)210205(10)231; v2.3.2: (01)00860001471717(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471717 ()


  • Hearing aid/implant system remote control

Miracle-Ear App - 00860001471700

App IOS 2.0.1. This database entry also covers the following minor/medium software updates: v2.0.2: (01)00860001471700(11)190807(10)202; v2.0.3: (01)00860001471700(11)190927(10)203; v2.0.4: (01)00860001471700(11)191014(10)204; v2.0.5: (01)00860001471700(11)191218(10)205; v2.0.6:(01)00860001471700(11)200227(10)206; v2.1.0: (01)00860001471700(11)200528(10)210; v2.2.1: (01)00860001471700(11)200729(10)221; v2.3.0: (01)00860001471700(11)201217(10)230; v2.3.1: (01)00860001471700(11)210205(10)231; v2.3.2: (01)00860001471700(11)210507(10)232
AMPLIFON SPA
2.0.1
In Commercial Distribution

  • 00860001471700 ()


  • Hearing aid/implant system remote control

HUDSON RCI - 14026704661326

MICRO MIST NEB W/ELONG PED MASK,TBG & UN
TELEFLEX INCORPORATED
IPN049813
In Commercial Distribution

  • 24026704661323 ()
  • 14026704661326 ()
1946

  • Benchtop nebulizer, non-heated

HUDSON RCI - 14026704670922

MICRO MIST NEB W/ELONG PED MASK,TBG & UN
TELEFLEX INCORPORATED
IPN914792
In Commercial Distribution

  • 24026704670929 ()
  • 14026704670922 ()
1946

  • Benchtop nebulizer, non-heated

GEN4 Direct Access - 00840828107273

GEN4 Direct Access
CURBELL MEDICAL PRODUCTS, INC.
4C360N-Z003008
In Commercial Distribution

  • 00840828107273 ()
1946

  • Pillow speaker

Hudson RCI - 04026704580361

MICRO MIST NEB W/ELONG PED MASK,TBG & UN
TELEFLEX INCORPORATED
IPN043778
In Commercial Distribution

  • 24026704580365 ()
  • 04026704580361 ()
1946

  • Benchtop nebulizer, non-heated

Assure - D798APP0

Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention.
RELIANCE ORTHODONTIC PRODUCTS INC
APP
In Commercial Distribution

  • D798APP0 ()
APP

  • Orthodontic bracket adhesive

MC2 App - 00860008892744

No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


  • Hand-held basic diagnostic x-ray system, digital

N/A - 00840329814359

INJECTION GUN FOR MONOJECT TOOMEY 60CC SYRINGE
BLACK & BLACK SURGICAL, INC.
B89IGS-60CC
In Commercial Distribution

  • 00840329814359 ()
B89IGS-60CC

  • Syringe autofill kit

N/A - 00840329814342

INJECTION GUN SET, FOR 3CC, 5CC, 10CC BD SYRINGE
BLACK & BLACK SURGICAL, INC.
B89IGS-3510CC
In Commercial Distribution

  • 00840329814342 ()
B89IGS-3510CC

  • Syringe autofill kit

Auto-Fill® syringe kit - M20676000

The AUTO-FILL Syringe Kit is indicated for introduction of dilute lidocaine solutions into the subcutaneous tissue for the purposes of local anesthesia.
Vascular Solutions, Inc.
7600
Not in Commercial Distribution

  • M20676000 ()
  • M20676001 ()


  • Syringe autofill kit

StealthStation Cranial Software - 00643169865341

SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system

Rexton - 05714880113204

APP REXTON
Ws Audiology Usa, Inc.
Rexton App
In Commercial Distribution

  • 05714880113204 ()
10996567

  • Hearing aid/implant system remote control

AudioService - 05714880113198

APP AUDIOSERVICE
Ws Audiology Usa, Inc.
AudioService App
In Commercial Distribution

  • 05714880113198 ()
10996566

  • Hearing aid/implant system remote control

myRemote - 05714880113181

APP MYREMOTE
Ws Audiology Usa, Inc.
myRemote App
In Commercial Distribution

  • 05714880113181 ()
10996565

  • Hearing aid/implant system remote control

Vibe - 05714880113174

APP VIBE
Ws Audiology Usa, Inc.
Vibe App
In Commercial Distribution

  • 05714880113174 ()
10996564

  • Hearing aid/implant system remote control

Signia - 05714880113167

APP SIGNIA
Ws Audiology Usa, Inc.
Signia App
In Commercial Distribution

  • 05714880113167 ()
10996563

  • Hearing aid/implant system remote control

TruHearing - 05714880113150

APP TRUHEARING
Ws Audiology Usa, Inc.
TruHearing App
In Commercial Distribution

  • 05714880113150 ()
10996369

  • Hearing aid/implant system remote control

Hearing Help Express - 00858177007335

Android App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007335 ()
23354

  • Audiometric/hearing device software

hiHealth Innovations - 00858177007144

Android App
INTRICON CORPORATION
hiHearing
In Commercial Distribution

  • 00858177007144 ()
22958

  • Audiometric/hearing device software

Hearing Help Express - 00858177007113

iOS App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007113 ()
23150

  • Audiometric/hearing device software

Sonova - 07613389310979

myPhonak app
Sonova AG
088-0011
In Commercial Distribution

  • 07613389310979 ()
088-0011

  • Audiometric/hearing device software

Phonak - 07613389082623

myPhonak (App)
Sonova AG
088-0008-03
In Commercial Distribution

  • 07613389082623 ()
088-0008-03

  • Audiometric/hearing device software

PRC - 00816486021060

Quasselkiste App
PRENTKE ROMICH COMPANY
Quasselkiste App
In Commercial Distribution

  • 00816486021060 ()
19285-2

  • Voice synthesizer/digitizer

audifon - EADF03410600217207189

audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.3
In Commercial Distribution

  • EADF03410600217207189 ()
03410600217207189

  • Hearing aid wireless-fitting computer-aided set

audifon - EADF034106002172068681

audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.2
In Commercial Distribution

  • EADF034106002172068681 ()
03410600217206868

  • Hearing aid wireless-fitting computer-aided set
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