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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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25ga Stellaris Elite Vitrectomy Probe
SYNERGETICS USA, INC.
SE5625
In Commercial Distribution

  • 20841305111442 ()
  • 10841305111438 ()
SE5625

  • Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)
23ga Stellaris Elite Vitrectomy Probe
SYNERGETICS USA, INC.
SE5623
In Commercial Distribution

  • 20841305111428 ()
  • 10841305111414 ()
SE5623

  • Hereditary cerebral haemorrhage with amyloidosis (Dutch type) IVD, kit, nucleic acid technique (NAT)
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
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
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
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
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
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
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
No Description
OXOS Medical, Inc.
APP
In Commercial Distribution

  • 00860008892744 ()


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