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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Cara i500 ios scanner
Kulzer GmbH
66077970
In Commercial Distribution

  • J014660779700 ()
66077970

  • Dental milling system, CAD/CAM, laboratory
SEER 1000 IOS APPLICATION
Ge Medical Systems Information Technologies, Inc.
1000 IOS Application
In Commercial Distribution

  • 00840682116879 ()


  • Electrocardiographic ambulatory recorder
Vscan Air for iOS
GE Vingmed Ultrasound AS
Air for iOS
In Commercial Distribution

  • 00840682147071 ()


  • Ultrasound imaging system application software
WVSM Management Suite - iOS
ATHENA GTX, INC.
iOS Software
In Commercial Distribution

  • B3943950006000 ()
395-0006-00

  • Centralized patient monitor
On1 IOS Replica WP
Nobel Biocare AB
38742
In Commercial Distribution

  • 07332747113778 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
In Commercial Distribution

  • 07332747113761 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
In Commercial Distribution

  • 07332747113754 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica WP
Nobel Biocare AB
38742
In Commercial Distribution

  • 07332747213072 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
In Commercial Distribution

  • 07332747213065 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
In Commercial Distribution

  • 07332747213058 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica WP
Nobel Biocare AB
38742
Not in Commercial Distribution

  • 07332747176278 ()

  • Outer Diameter: 6.500 Millimeter
38742

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica RP
Nobel Biocare AB
38741
Not in Commercial Distribution

  • 07332747176261 ()

  • Outer Diameter: 5.300 Millimeter
38741

  • Dental implant suprastructure, temporary, preformed, single-use
On1 IOS Replica NP
Nobel Biocare AB
38740
Not in Commercial Distribution

  • 07332747176254 ()

  • Outer Diameter: 4.800 Millimeter
38740

  • Dental implant suprastructure, temporary, preformed, single-use
TG Post Abutment Driver
TITAN IMPLANT INC
T-TGAD
In Commercial Distribution

  • 00842448116390 ()


  • Surgical screwdriver, reusable
SCALER/HOE U15/TG
Power Dental U.S.A. Inc.
1707
In Commercial Distribution

  • D94317070 ()
1707

  • Dental excavator, reusable
  • Manual dental scaler, reusable
PERIODONTAL CHISEL, DE, TG
NORDENT MANUFACTURING INC
CECPTG
In Commercial Distribution

  • 00840018641600 ()


  • Periodontal hoe
Obturator for 26182 TG
Karl Storz GmbH & Co. KG
26182TH
In Commercial Distribution

  • 04048551102282 ()


  • Rigid endoscope obturator
Salvin TG Periodontal Chisel
SALVIN DENTAL SPECIALTIES, LLC
PERIO-CHISEL-TG
In Commercial Distribution

  • 00841336106437 ()
PERIO-CHISEL-TG

  • Dental osteotome
CERAMAGE UP TG 5G
SHOFU DENTAL CORPORATION
2364
In Commercial Distribution

  • E23523640 ()
2364

  • Dental prosthesis veneer resin
Ceramage Trans Effects TG
SHOFU DENTAL CORPORATION
1934
In Commercial Distribution

  • E23519340 ()
1934

  • Dental prosthesis veneer resin
TGDN TG POST DRIVER
EMERY ENTERPRISES INC
TGDN
In Commercial Distribution

  • 00817686024189 ()


  • Screw endosteal dental implant, two-piece
PK, TG HEART ACCESSORY
MEDLINE INDUSTRIES, INC.
DYNJ88616
In Commercial Distribution

  • 40198459185107 ()
  • 10198459185106 ()
DYNJ88616

  • General surgical procedure kit, non-medicated, single-use
Chisel, Kirkland 13K/TG
Storz am Mark GmbH
12843.00
In Commercial Distribution

  • ESAM12843000 ()
  • ESAM12843001 ()
12843.00

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

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system
#13K/TG DE Curette/Chisel
HU-FRIEDY MFG. CO., LLC
S13K/TG
In Commercial Distribution

  • 10889950022549 ()
S13K/TG

  • Periodontal file/rasp, manual
No Description
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Labat TG
In Commercial Distribution

  • 06971355420642 ()


  • General-purpose ultrasound imaging system
Android App
INTRICON CORPORATION
HHE Hearing
In Commercial Distribution

  • 00858177007335 ()
23354

  • Audiometric/hearing device software
Android App
INTRICON CORPORATION
hiHearing
In Commercial Distribution

  • 00858177007144 ()
22958

  • Audiometric/hearing device software
APP REXTON
Ws Audiology Usa, Inc.
Rexton App
In Commercial Distribution

  • 05714880113204 ()
10996567

  • Hearing aid/implant system remote control
APP AUDIOSERVICE
Ws Audiology Usa, Inc.
AudioService App
In Commercial Distribution

  • 05714880113198 ()
10996566

  • Hearing aid/implant system remote control
APP MYREMOTE
Ws Audiology Usa, Inc.
myRemote App
In Commercial Distribution

  • 05714880113181 ()
10996565

  • Hearing aid/implant system remote control
APP VIBE
Ws Audiology Usa, Inc.
Vibe App
In Commercial Distribution

  • 05714880113174 ()
10996564

  • Hearing aid/implant system remote control
APP SIGNIA
Ws Audiology Usa, Inc.
Signia App
In Commercial Distribution

  • 05714880113167 ()
10996563

  • Hearing aid/implant system remote control
APP TRUHEARING
Ws Audiology Usa, Inc.
TruHearing App
In Commercial Distribution

  • 05714880113150 ()
10996369

  • Hearing aid/implant system remote control
audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.3
In Commercial Distribution

  • EADF03410600217207189 ()
03410600217207189

  • Hearing aid wireless-fitting computer-aided set
audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.2
In Commercial Distribution

  • EADF034106002172068681 ()
03410600217206868

  • Hearing aid wireless-fitting computer-aided set
Quasselkiste App
PRENTKE ROMICH COMPANY
Quasselkiste App
In Commercial Distribution

  • 00816486021060 ()
19285-2

  • Voice synthesizer/digitizer
myPhonak app
Sonova AG
088-0011
In Commercial Distribution

  • 07613389310979 ()
088-0011

  • Audiometric/hearing device software
myPhonak (App)
Sonova AG
088-0008-03
In Commercial Distribution

  • 07613389082623 ()
088-0008-03

  • Audiometric/hearing device software
Vision testing application - iOS version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376157 ()


  • Vision self-testing software
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