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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S13K/TG COMB. 5 MM #6 Handle
HU-FRIEDY MFG. CO., LLC
PJO/26
In Commercial Distribution

  • 10889950018924 ()
PJO/26

  • Periodontal file/rasp, manual
S13K/TG COMB. 4 MM #6 Handle
HU-FRIEDY MFG. CO., LLC
PJO/16
In Commercial Distribution

  • 10889950018900 ()
PJO/16

  • Periodontal file/rasp, manual
#13/TG DE CURRETTE/CHISEL, #6 HANDLE
HU-FRIEDY MFG. CO., LLC
S13K/TG6
In Commercial Distribution

  • 10889950022556 ()
S13K/TG6

  • Periodontal file/rasp, manual
S13K/TG DE Curette/Chisel, Black Line
HU-FRIEDY MFG. CO., LLC
S13K/TGX
In Commercial Distribution

  • 10889950110321 ()
S13K/TGX

  • Periodontal file/rasp, manual
Lumify Diagnostic Ultrasound System iOS Release 5.1
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838124141 ()


  • General-purpose ultrasound imaging system
SW 31302 CARELINK EXPRESS MOBILE IOS USA
MEDTRONIC, INC.
31302
In Commercial Distribution

  • 00643169636668 ()


  • Implantable cardiac device management application software
4.8mm TG Post Abutment Analog 5.5mm Height
TITAN IMPLANT INC
T-55TGPA
In Commercial Distribution

  • 00842448111043 ()


  • Dental implant abutment analog, laboratory
4.8mm TG Post Abutment Analog Height: 4.0mm
TITAN IMPLANT INC
T-4TGPA
In Commercial Distribution

  • 00842448110992 ()


  • Dental implant abutment analog, laboratory
4.8mm TG Hex Abutment Plastic Sleeve Non-Hex
TITAN IMPLANT INC
T-48TGIAPSNH
In Commercial Distribution

  • 00842448109880 ()


  • Dental implant suprastructure, temporary, preformed, single-use
4.8mm TG Hex Abutment Plastic Sleeve Hex
TITAN IMPLANT INC
T-48TGIAPSH
In Commercial Distribution

  • 00842448109873 ()


  • Dental implant suprastructure, temporary, preformed, single-use
G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Tandem t:slim Mobile Application, iOS version 2.9
Tandem Diabetes Care, Inc.
1014707
In Commercial Distribution

  • 00389152470740 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
XiVE® TG Lab Set Bridge cast-to
Dentsply Implants Manufacturing GmbH
32259905
Not in Commercial Distribution

  • EFRI322599052 ()
25-9905

  • Dental implant suprastructure kit
XiVE® TG Lab Set Bridge castable
Dentsply Implants Manufacturing GmbH
32259900
Not in Commercial Distribution

  • EFRI322599002 ()
25-9900

  • Dental implant suprastructure kit
XiVE® TG Lab Set Castable Coping
Dentsply Implants Manufacturing GmbH
32259800
Not in Commercial Distribution

  • EFRI322598002 ()
25-9800

  • Dental implant suprastructure kit
XiVE® TG Lab Set Titanium Coping
Dentsply Implants Manufacturing GmbH
32259700
Not in Commercial Distribution

  • EFRI322597002 ()
25-9700

  • Dental implant suprastructure kit
XiVE® TG Abutment angled D3.4-4.5/A15
Dentsply Implants Manufacturing GmbH
32254510
Not in Commercial Distribution

  • EFRI322545102 ()
25-4510

  • Dental implant suprastructure, permanent, preformed
XiVE® TG Abutment straight D3.4-4.5/A0
Dentsply Implants Manufacturing GmbH
32254500
Not in Commercial Distribution

  • EFRI322545002 ()
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

  • EFRI322542462 ()
25-4246

  • Dental implant suprastructure, permanent, preformed
XiVE® TG plus Implant D4.5/L15
Dentsply Implants Manufacturing GmbH
32252455
Not in Commercial Distribution

  • EFRI322524552 ()
25-2455

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

  • EFRI322524532 ()
25-2453

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

  • EFRI322524522 ()
25-2452

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

  • EFRI322524512 ()
25-2451

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

  • EFRI322524502 ()
25-2450

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

  • EFRI322524452 ()
25-2445

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

  • EFRI322524432 ()
25-2443

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

  • EFRI322524422 ()
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

  • EFRI322524412 ()
25-2441

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

  • EFRI322524402 ()
25-2440

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

  • EFRI322524352 ()
25-2435

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

  • EFRI322524332 ()
25-2433

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

  • EFRI322524322 ()
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

  • EFRI322524312 ()
25-2431

  • Screw endosteal dental implant, one-piece
XiVE® TG Cover Screw for Implants
Dentsply Implants Manufacturing GmbH
32251400
Not in Commercial Distribution

  • EFRI322514002 ()
25-1400

  • Dental implant suprastructure, temporary, preformed, single-use
6.5mm TG Hex Abutment Plastic Sleeve Hex
TITAN IMPLANT INC
TN2-65TGHAPSH
In Commercial Distribution

  • 00842448115577 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Titan Design 6.5mm Platform TG Hex Abutment
TITAN IMPLANT INC
TN2-65TGHA
In Commercial Distribution

  • 00842448115515 ()


  • Dental implant suprastructure, permanent, preformed
4.8mm TG Ball Head Abutment Gh 4.0mm
TITAN IMPLANT INC
T-TGBHA-4.0
In Commercial Distribution

  • 00842448112743 ()


  • Dental implant suprastructure, permanent, preformed
4.8mm TG Ball Head Abutment Gh 3.0mm
TITAN IMPLANT INC
T-TGBHA-3.0
In Commercial Distribution

  • 00842448112736 ()


  • Dental implant suprastructure, permanent, preformed
4.8mm TG Ball Head Abutment Gh 2.0mm
TITAN IMPLANT INC
T-TGBHA-2.0
In Commercial Distribution

  • 00842448112729 ()


  • Dental implant suprastructure, permanent, preformed
4.8mm TG Ball Head Abutment Gh 1.0mm
TITAN IMPLANT INC
T-TGBHA-1.0
In Commercial Distribution

  • 00842448112712 ()


  • Dental implant suprastructure, permanent, preformed
4.8mm TG Ball Head Abutment Gh 0.0mm
TITAN IMPLANT INC
T-TGBHA-0.0
In Commercial Distribution

  • 00842448112705 ()


  • Dental implant suprastructure, permanent, preformed
Titan Design 4.8mm Tg Hex Abutment Analog
TITAN IMPLANT INC
TN-48TGHAA
In Commercial Distribution

  • 00842448112330 ()


  • Dental implant abutment analog, laboratory
4.8mm TG Post Abutment Analog Height 7.0mm
TITAN IMPLANT INC
T-7TGPA
In Commercial Distribution

  • 00842448112057 ()


  • Dental implant abutment analog, laboratory
DreamMapper App iOS, Asia-Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054288 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper App iOS, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054271 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS, North American Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054264 ()
1101478

  • Self-care monitoring/reporting software
iOS version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078962 ()
P1646054

  • Audiometric/hearing device software
TG Ab Dil.Ancill.RP (2PK) - CENTAUR - CONS - 2x5mL
Siemens Healthcare Diagnostics Inc.
10310430
In Commercial Distribution

  • 00630414460833 ()
  • 00630414003368 ()
128280

  • Buffered sample diluent IVD
TG Ab Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387073
In Commercial Distribution

  • 00630414954318 ()
L2TYZ

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, control
TG PRO TACO ANKLE 30% XL LEFT
MEDI MANUFACTURING, INC.
501996
In Commercial Distribution

  • 00636257157121 ()


  • Ankle/foot orthosis
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