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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No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA2513
In Commercial Distribution

  • 08435389819714 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA2511
In Commercial Distribution

  • 08435389819707 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA2585
In Commercial Distribution

  • 08435389819677 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA2510
In Commercial Distribution

  • 08435389819646 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA3085
In Commercial Distribution

  • 08435389819097 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA3010
In Commercial Distribution

  • 08435389819073 ()


  • Screw endosteal dental implant, two-piece
No Description
Roche Diagnostics GmbH
7030207190
In Commercial Distribution

  • 04015630934850 ()
7030207190

  • Cancer antigen 125 (CA125) IVD, calibrator
No Description
Roche Diagnostics GmbH
6343422160
In Commercial Distribution

  • 04015630930494 ()
6343422160

  • Multiple-type clinical chemistry analyte profile IVD, control
Cervical Cage
SpineArt SA
MOS-CA 14 08-S
In Commercial Distribution

  • 07640139340078 ()

  • Height: 08 Millimeter
  • Depth: 14 Millimeter


  • Polymeric spinal fusion cage, sterile
Cervical Cage
SpineArt SA
MOS-CA 14 07-S
In Commercial Distribution

  • 07640139340061 ()

  • Height: 07 Millimeter
  • Depth: 14 Millimeter


  • Polymeric spinal fusion cage, sterile
Cervical Cage
SpineArt SA
MOS-CA 14 05-S
In Commercial Distribution

  • 07640139340047 ()

  • Height: 05 Millimeter
  • Depth: 14 Millimeter


  • Polymeric spinal fusion cage, sterile
Cervical Cage
SpineArt SA
MOS-CA 12 07-S
In Commercial Distribution

  • 07640139340030 ()

  • Height: 07 Millimeter
  • Depth: 12 Millimeter


  • Polymeric spinal fusion cage, sterile
Cervical Cage
SpineArt SA
MOS-CA 12 06-S
In Commercial Distribution

  • 07640139340023 ()

  • Depth: 12 Millimeter
  • Height: 06 Millimeter


  • Polymeric spinal fusion cage, sterile
Cervical Cage
SpineArt SA
MOS-CA 12 05-S
In Commercial Distribution

  • 07640139340016 ()

  • Height: 05 Millimeter
  • Depth: 12 Millimeter


  • Polymeric spinal fusion cage, sterile
Specialty Absorptive, wound dressing
SMITH & NEPHEW MEDICAL LIMITED
5999M38
In Commercial Distribution

  • 30040565120813 ()
  • 00040565120812 ()
5999M38

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211131 ()


  • Cancer antigen 125 (CA125) IVD, reagent
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211124 ()


  • Cancer antigen 19-9 (CA19-9) IVD, reagent
Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700737-001
In Commercial Distribution

  • J00717007370011 ()
1700737-001

  • Surgical power tool system control unit, line-powered
Sets of Chiropro systems and their dental micromotors or contra-angles plus relevant accessories
Bien-Air Dental SA
1700703-001
In Commercial Distribution

  • J00717007030011 ()
1700703-001

  • Surgical power tool system control unit, line-powered
Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor.
Bien-Air Dental SA
1601237-001
In Commercial Distribution

  • J00716012370011 ()


  • Dental laboratory drilling system handpiece
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601138-0
In Commercial Distribution

  • J007160113801 ()
1601138-0

  • Dental laboratory drilling system handpiece
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601060-001
In Commercial Distribution

  • J00716010600011 ()
1601060-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601059-001
In Commercial Distribution

  • J00716010590011 ()
1601059-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600940-001
In Commercial Distribution

  • J00716009400011 ()
1600940-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed.
Bien-Air Dental SA
1600938-0
In Commercial Distribution

  • J007160093801 ()
1600938-0

  • Dental laboratory drilling system handpiece
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600938-001
In Commercial Distribution

  • J00716009380011 ()
1600938-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600786-001
In Commercial Distribution

  • J00716007860011 ()
1600786-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600603-001
In Commercial Distribution

  • J00716006030011 ()
1600603-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600479-001
In Commercial Distribution

  • J00716004790011 ()
1600479-001

  • Dental power tool system handpiece, remotely-driven
No Description
FUJIREBIO INC.
235126
Not in Commercial Distribution

  • 04987270235126 ()

  • Size Type = Tests per kit; Size Unit = 42; Unit of Measure = Tests


  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
235102
In Commercial Distribution

  • 04987270235102 ()

  • Size Test =Tests per kit; Size Unit = 42; Unit of Measure = Tests


  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
CA19-9 master material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10325894
In Commercial Distribution

  • 00630414447926 ()
123518

  • Cancer antigen 19-9 (CA19-9) IVD, control
Biotyper system for clinical use in the USA, with smartbeam laser.
Bruker Daltonik GmbH
1890233
In Commercial Distribution

  • 04251204326359 ()
1890233

  • Microbial identification mass spectrometry system IVD
Biotyper system for clinical use in the USA, with smartbeam laser.
Bruker Daltonik GmbH
1890232
In Commercial Distribution

  • 04251204326311 ()
1890232

  • Microbial identification mass spectrometry system IVD
No Description
CELL MARQUE CORPORATION
325M-18
In Commercial Distribution

  • 00841683136347 ()


  • Cancer antigen 125 (CA125) IVD, antibody
No Description
CELL MARQUE CORPORATION
325M-17
In Commercial Distribution

  • 00841683136330 ()


  • Cancer antigen 125 (CA125) IVD, antibody
No Description
CELL MARQUE CORPORATION
325M-15
In Commercial Distribution

  • 00841683136316 ()


  • Cancer antigen 125 (CA125) IVD, antibody
Biotyper system for clinical use in the USA with smart laser, for Becton Dickson.
Bruker Scientific LLC
8605214
Not in Commercial Distribution

  • 00841594110047 ()
8605214

  • Microbial identification mass spectrometry system IVD
Provide calibration points for the Na, K, Cl and Li electrodes.
Diamond Diagnostics Inc.
ME-2123D
In Commercial Distribution

  • 00811403015917 ()


  • Multiple blood gas analyte IVD, control
This is a medical device.
ARIBEX, INC.
1.013.7789
In Commercial Distribution

  • EKAV101377890 ()
1.013.7789

  • Diagnostic x-ray system generator, hand-held
Interface Cable of length 85" with a round shape, 6-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684200
In Commercial Distribution

  • 50886333642002 ()
  • 00886333642007 ()

  • cable length 85"
684200

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 6-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684192
In Commercial Distribution

  • 50886333641920 ()
  • 00886333641925 ()

  • cable length 150"
684192

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 7-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684178
In Commercial Distribution

  • 50886333641784 ()
  • 00886333641789 ()

  • cable length 150"
684178

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 6-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684161
In Commercial Distribution

  • 50886333641616 ()
  • 00886333641611 ()

  • cable length 150"
684161

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 12-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684150
In Commercial Distribution

  • 50886333641500 ()
  • 00886333641505 ()

  • cable length 150"
684150

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 5-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684120
In Commercial Distribution

  • 50886333641203 ()
  • 00886333641208 ()

  • cable length 150"
684120

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a round shape, 10-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684104
In Commercial Distribution

  • 50886333641043 ()
  • 00886333641048 ()

  • cable length 150"
684104

  • Electrical-only medical device connection cable, reusable
Interface Cable of length 150" with a rectangular shape, 11-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684102
In Commercial Distribution

  • 50886333641029 ()
  • 00886333641024 ()

  • cable length 150"
684102

  • Electrical-only medical device connection cable, reusable
Interface Cable to interface Transducer to Monitor. It has a 5-pin monitor connector and the cable length is 150"
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684090
In Commercial Distribution

  • 50886333640909 ()
  • 00886333640904 ()

  • cable length 150"
684090

  • Electrical-only medical device connection cable, reusable
Interface Cable to interface Transducer to Monitor. It has a 10-pin monitor connector and the cable length is 150"
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684089
In Commercial Distribution

  • 50886333640893 ()
  • 00886333640898 ()

  • cable length 150"
684089

  • Electrical-only medical device connection cable, reusable
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