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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4CIS® Marlin Trial 14x14, H5
ALPHANOX CO.,LTD.
5901-0153
In Commercial Distribution

  • 08806373583360 ()
5901-0153

  • Transfemoral amputation tissue-reinforcement implant trial
4CIS® Marlin Trial 14x12, H5
ALPHANOX CO.,LTD.
5901-0145
In Commercial Distribution

  • 08806373583285 ()
5901-0145

  • Transfemoral amputation tissue-reinforcement implant trial
4CIS® Marlin Trial 12x12, H5
ALPHANOX CO.,LTD.
5901-0137
In Commercial Distribution

  • 08806373583209 ()
5901-0137

  • Transfemoral amputation tissue-reinforcement implant trial
Hygienist Golden Scaler #3. H5/33
GoldenDent
GH3
In Commercial Distribution

  • 00850011211335 ()
GH3

  • Manual dental scaler, reusable
H5/J1 SCALER RND HOLLOW #4H
DARBY DENTAL SUPPLY, LLC
9430448
In Commercial Distribution

  • 00889813037478 ()
9430448

  • Manual dental scaler, reusable
H5/33 SCALER RND HOLLOW #4H
DARBY DENTAL SUPPLY, LLC
9430446
In Commercial Distribution

  • 00889813037461 ()
9430446

  • Manual dental scaler, reusable
SCALER HYGIENIST H5/J1 DE #6H
DARBY DENTAL SUPPLY, LLC
5257291
In Commercial Distribution

  • 00889813066409 ()


  • Manual dental scaler, reusable
SCALER HYGIENIST H5/J1 DE #2H
DARBY DENTAL SUPPLY, LLC
5257290
In Commercial Distribution

  • 00889813066393 ()


  • Manual dental scaler, reusable
SCALER HYGIENIST H5/33 DE #4H
DARBY DENTAL SUPPLY, LLC
5257286
In Commercial Distribution

  • 00889813066355 ()


  • Manual dental scaler, reusable
SCALER HYGIENIST H5/33 DE #2H
DARBY DENTAL SUPPLY, LLC
5257285
In Commercial Distribution

  • 00889813066348 ()


  • Manual dental scaler, reusable
Mecta-C SA – Plate Quattro Lag h5
Medacta International SA
03.18.415
In Commercial Distribution

  • 07630040726177 ()


  • Metallic spinal interbody fusion cage
Mecta-C SA – Plate Quattro Lock h5
Medacta International SA
03.18.405
In Commercial Distribution

  • 07630040726092 ()


  • Metallic spinal interbody fusion cage
Mecta-C SA – Plate Trio Lag h5
Medacta International SA
03.18.315
In Commercial Distribution

  • 07630040726016 ()


  • Metallic spinal interbody fusion cage
Mecta-C SA – Plate Trio Lock h5
Medacta International SA
03.18.305
In Commercial Distribution

  • 07630040725934 ()


  • Metallic spinal interbody fusion cage
Straight abutment H5 Internal Hex RP
UNIQA DENTAL LTD
USBR-4605
In Commercial Distribution

  • 07290112858788 ()
USBR-4605

  • Dental implant suprastructure, permanent, preformed
Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution

  • 10385081120302 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system
SW APP A620 DBS PATIENT APP V3.0 LK55
MEDTRONIC, INC.
A620
In Commercial Distribution

  • 00763000523329 ()


  • Multiple active implantable device programmer
SW APP A610 DBS CLINICIAN APP V4.0 LK54
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000523312 ()


  • Multiple active implantable device programmer
Viewfinder remote app
Edwards Lifesciences LLC
VFREM
In Commercial Distribution

  • 00690103215847 ()
VFREM

  • Bedside monitor remote-viewing software, physiological parameter
  • General-purpose multi-parameter bedside monitor
APP HEAR.COM HORIZON
Ws Audiology Usa, Inc.
hear.com horizon
In Commercial Distribution

  • 05714880113228 ()
10996569

  • Hearing aid/implant system remote control
BEYOND app iOS
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069659689 ()
5 300 0003 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
COM-DEX app Android
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599985 ()
5 300 0001 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
COM-DEX app iOS
Widex A/S
COM-DEX APP
In Commercial Distribution

  • 05706069599978 ()
5 300 0000 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007293 ()
RX22773-004

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007255 ()
RX22773-002

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007248 ()
RX22773-001

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007231 ()
RX22711-002

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007224 ()
RX22711-001

  • Telemetric electrocardiographic ambulatory recorder
Sirona PC App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007194 ()
RX22773-003

  • Telemetric electrocardiographic ambulatory recorder
Sirona Android App
DATRIX LLC
Sirona
In Commercial Distribution

  • 00851074007170 ()
RX22711-003

  • Telemetric electrocardiographic ambulatory recorder
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