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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BANFFF - TG - Tofee Grain - 52 * 17 - 135
Incite International Inc
2551TG
In Commercial Distribution

  • G1312551TG0 ()
  • 00810109935383 ()


  • Spectacle frame
XiVE® TG plus Implant D4.5/L15
Dentsply Implants Manufacturing GmbH
32252455
Not in Commercial Distribution

25-2455

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D4.5/L11
Dentsply Implants Manufacturing GmbH
32252452
Not in Commercial Distribution

25-2452

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D4.5/L8
Dentsply Implants Manufacturing GmbH
32252450
Not in Commercial Distribution

25-2450

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.8/L15
Dentsply Implants Manufacturing GmbH
32252445
Not in Commercial Distribution

25-2445

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.8/L13
Dentsply Implants Manufacturing GmbH
32252443
Not in Commercial Distribution

25-2443

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.8/L11
Dentsply Implants Manufacturing GmbH
32252442
Not in Commercial Distribution

25-2442

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.8/L9.5
Dentsply Implants Manufacturing GmbH
32252441
Not in Commercial Distribution

25-2441

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.8/L8
Dentsply Implants Manufacturing GmbH
32252440
Not in Commercial Distribution

25-2440

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.4/L15
Dentsply Implants Manufacturing GmbH
32252435
Not in Commercial Distribution

25-2435

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.4/L13
Dentsply Implants Manufacturing GmbH
32252433
Not in Commercial Distribution

25-2433

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.4/L11
Dentsply Implants Manufacturing GmbH
32252432
Not in Commercial Distribution

25-2432

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D3.4/L9.5
Dentsply Implants Manufacturing GmbH
32252431
Not in Commercial Distribution

25-2431

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D4.5/L13
Dentsply Implants Manufacturing GmbH
32252453
Not in Commercial Distribution

25-2453

  • Screw endosteal dental implant, one-piece
XiVE® TG plus Implant D4.5/L9.5
Dentsply Implants Manufacturing GmbH
32252451
Not in Commercial Distribution

25-2451

  • Screw endosteal dental implant, one-piece
Vial Adapter 20mm FLL SIL TG - VF
WEST PHARMA. SERVICES IL, . LTD
8072036
In Commercial Distribution

  • 27290108240096 ()
  • 17290108240099 ()
  • 07290108240092 ()


  • Vial/bottle adaptor, non-hermetic
XiVE® TG Abutment angled D3.4-4.5/A15
Dentsply Implants Manufacturing GmbH
32254510
Not in Commercial Distribution

25-4510

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Abutment straight D3.4-4.5/A0
Dentsply Implants Manufacturing GmbH
32254500
In Commercial Distribution

25-4500

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Cast-to Waxing Sleeve D3.4-4.5
Dentsply Implants Manufacturing GmbH
32254246
Not in Commercial Distribution

25-4246

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Cover Screw for Implants
Dentsply Implants Manufacturing GmbH
32251400
Not in Commercial Distribution

25-1400

  • Dental implant suprastructure, temporary, preformed, single-use
PUMP,REPLACEMENT,APP,AIRONE
MEDLINE INDUSTRIES, INC.
MSCAOPUMP
In Commercial Distribution

  • 10080196403998 ()
MSCAOPUMP

  • Alternating-pressure inflator
ALLENTOWN LAP CHOLE APP
Cardinal Health 200, LLC
SLC11LLSL1
In Commercial Distribution

  • 50888439303597 ()
  • 10888439303599 ()
SLC11LLSL1

  • Laparoscopic surgical procedure kit, non-medicated, single-use
Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display
ON APP 1.2 ANDROID
Oticon A/S
176635
In Commercial Distribution

  • 05707131328526 ()


  • Hearing aid/implant system remote control
OvuSense 2 App - Android
VIO HEALTHTECH LIMITED
M032 Android
In Commercial Distribution

  • 05060508530114 ()


  • Thermometric fertility analyser
Beyond App Android 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689112 ()
5 300 0009 001

  • Hearing aid/implant system remote control
Widex ToneLink App Android
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702965 ()
5 300 0017 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Widex MOMENT App Android
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930320 ()
5 300 0022 001

  • Hearing aid enhanced audio device, telecommunication/multimedia
Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder
Sirona B PC App
DATRIX LLC
RX22673
In Commercial Distribution

  • 00851074007125 ()


  • Telemetric electrocardiographic ambulatory recorder
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