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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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Patient application for Android
MC10, INC.
SW-0042
Not in Commercial Distribution

  • B493SW0042 ()


  • Electronic goniometer/kinesiology sensor
  • Kinesiology ambulatory recorder
  • Biomechanical function analysis/rehabilitation software
Investigator application for Android
MC10, INC.
SW-0027
Not in Commercial Distribution

  • B493SW0027 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Sync application for Android
MC10, INC.
SW-0027
Not in Commercial Distribution

  • B493SW0026 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Link application for Android
MC10, INC.
SW-0025
Not in Commercial Distribution

  • B493SW0025 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Engage Android OTC Grey
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831481 ()
10094

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Black
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831467 ()
10092

  • Air-conduction hearing aid, receiver-in-the-ear
Custom ITC 128 Android
HEARING LAB TECHNOLOGY, LLC
ITC128-A
In Commercial Distribution

  • 00810068830934 ()
HLT-CUSITC128-A

  • Air-conduction hearing aid, canal
Engage Android OTC Beige
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831399 ()
10077

  • Air-conduction hearing aid, receiver-in-the-ear
No Description
A.M.A. PLASTICS
Edge to Edge
In Commercial Distribution

  • 00866868000381 ()
ZHA-100-01

  • Mandible-repositioning sleep-disordered breathing orthosis
No Description
Unique Surgical
M8 to M10
In Commercial Distribution

  • 00854515008439 ()
1182

  • Orthopaedic implant-instrument extension adaptor, reusable
Spectacle Frame, Size 55-17-145
MCGEE GROUP, INC., THE
TO Lincoln Gold
In Commercial Distribution

  • 00781096319053 ()
TRLINCOLN0GOLD0SUN

  • Spectacle frame
Spectacle Frame, Size 48-22-140
MCGEE GROUP, INC., THE
TO Boston Gold
In Commercial Distribution

  • 00781096319039 ()
TRBOSTON0GOLD0SUN

  • Spectacle frame
Spectacle Frame, Size 51-18-145
MCGEE GROUP, INC., THE
TO Memphis Gold
In Commercial Distribution

  • 00781096319015 ()
TRMEMPHIS0GOLD0OPT

  • Spectacle frame
Spectacle Frame, Size 50-19-140
MCGEE GROUP, INC., THE
TO Houston Tortoise
In Commercial Distribution

  • 00781096319008 ()
TRHOUSTON0TORT0OPT

  • Spectacle frame
Spectacle Frame, Size 50-19-52
MCGEE GROUP, INC., THE
TO Houston Black
In Commercial Distribution

  • 00781096318995 ()
TRHOUSTON0BLCK0OPT

  • Spectacle frame
Spectacle Frame, Size 49-20-145
MCGEE GROUP, INC., THE
TO Dayton Tortoise
In Commercial Distribution

  • 00781096318988 ()
TRDAYTON0TORT0OPT

  • Spectacle frame
Spectacle Frame, Size 48-22-142
MCGEE GROUP, INC., THE
TO Austin Tortoise
In Commercial Distribution

  • 00781096318964 ()
TRAUSTIN0TORT0OPT

  • Spectacle frame
Spectacle Frame, Size 48-22-140
MCGEE GROUP, INC., THE
TO Boston Silver
In Commercial Distribution

  • 00781096319046 ()
TRBOSTON0SILV0SUN

  • Spectacle frame
Spectacle Frame, Size 49-20-145
MCGEE GROUP, INC., THE
TO Dayton Gold
In Commercial Distribution

  • 00781096318971 ()
TRDAYTON0GOLD0OPT

  • Spectacle frame
Spectacle Frame, Size 48-22-142
MCGEE GROUP, INC., THE
TO Austin Silver
In Commercial Distribution

  • 00781096318957 ()
TRAUSTIN0SILV0OPT

  • Spectacle frame
No Description
DTS Digital Dental Lab
Porcelain Fused to
In Commercial Distribution

  • 06977512700084 ()


  • Dental bridge, metal-ceramic
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
Obturator for 26182 TG
Karl Storz GmbH & Co. KG
26182TH
In Commercial Distribution

  • 04048551102282 ()


  • Rigid endoscope obturator
PERIODONTAL CHISEL, DE, TG
NORDENT MANUFACTURING INC
CECPTG
In Commercial Distribution

  • 00840018641600 ()


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

  • 00841336106437 ()
PERIO-CHISEL-TG

  • Dental osteotome
TGDN TG POST DRIVER
EMERY ENTERPRISES INC
TGDN
In Commercial Distribution

  • 00817686024189 ()


  • Screw endosteal dental implant, two-piece
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
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
Diagnostix Portable 3.5v USB, PMV Oto, Xen,
AMERICAN DIAGNOSTIC CORP
54381X
In Commercial Distribution

  • 00634782602260 ()
  • 00634782100759 ()

  • Finger Thickness .31 to .79 inches.
54381X

  • Ophthalmic/otologic diagnostic set
Diagnostix Portable 3.5v USB, PMV Oto, LED,
AMERICAN DIAGNOSTIC CORP
54381L
In Commercial Distribution

  • 00634782602253 ()
  • 00634782100742 ()

  • Finger Thickness .31 to .79 inches.
54381L

  • Ophthalmic/otologic diagnostic set
Diagnostix Portable Set, 3.5v USB, PMV OtoX/Coax+ OphX, Soft,
AMERICAN DIAGNOSTIC CORP
543802XS
In Commercial Distribution

  • 00634782602246 ()
  • 00634782100735 ()

  • Finger Thickness .31 to .79 inches.
543802XS

  • Ophthalmic/otologic diagnostic set
Diagnostix Portable Set, 3.5v USB, PMV OtoX/Coax+ OphX,
AMERICAN DIAGNOSTIC CORP
543802X
In Commercial Distribution

  • 00634782602239 ()
  • 00634782100728 ()

  • Finger Thickness .31 to .79 inches.
543802X

  • Ophthalmic/otologic diagnostic set
Diagnostix Portable Set, 3.5v USB, PMV OtoL/Coax+ OphL, Soft,
AMERICAN DIAGNOSTIC CORP
543802LS
In Commercial Distribution

  • 00634782602222 ()
  • 00634782100711 ()

  • Finger Thickness .31 to .79 inches.
543802LS

  • Ophthalmic/otologic diagnostic set
Diagnostix Portable Set, 3.5v USB, PMV OtoL/Coax+ OphL,
AMERICAN DIAGNOSTIC CORP
543802L
In Commercial Distribution

  • 00634782602215 ()
  • 00634782100704 ()

  • Finger Thickness .31 to .79 inches.
543802L

  • Ophthalmic/otologic diagnostic set
Diagnostix Portable Set, 3.5v USB, PMV OtoX/Coax+ OphL, Soft,
AMERICAN DIAGNOSTIC CORP
543802BS
In Commercial Distribution

  • 00634782602208 ()
  • 00634782100698 ()

  • Finger Thickness .31 to .79 inches.
543802BS

  • Ophthalmic/otologic diagnostic set
Diagnostix Portable Set, 3.5v USB, PMV OtoX/Coax+ OphL,
AMERICAN DIAGNOSTIC CORP
543802B
In Commercial Distribution

  • 00634782602192 ()
  • 00634782100681 ()

  • Finger Thickness .31 to .79 inches.
543802B

  • Ophthalmic/otologic diagnostic set
Diagnostix Portable Set, 3.5v USB, PMV OtoL/Coax+ OphX, Soft,
AMERICAN DIAGNOSTIC CORP
543802AS
In Commercial Distribution

  • 00634782602185 ()
  • 00634782100674 ()

  • Finger Thickness .31 to .79 inches.
543802AS

  • Ophthalmic/otologic diagnostic set
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