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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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
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
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
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA3385
In Commercial Distribution

  • 08435389820147 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA3313
In Commercial Distribution

  • 08435389820116 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA3311
In Commercial Distribution

  • 08435389820109 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA3310
In Commercial Distribution

  • 08435389820093 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA3013
In Commercial Distribution

  • 08435389819738 ()


  • Screw endosteal dental implant, two-piece
No Description
BIOTECHNOLOGY INSTITUTE SL
IIP3CA3011
In Commercial Distribution

  • 08435389819721 ()


  • Screw endosteal dental implant, two-piece
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
Specialty Absorptive, wound dressing
SMITH & NEPHEW MEDICAL LIMITED
5999M38
In Commercial Distribution

  • 30040565120813 ()
  • 00040565120812 ()
5999M38

  • Exudate-absorbent dressing, non-gel, non-antimicrobial
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
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
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 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 of 60" cable length with a round shape, 10-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684252
In Commercial Distribution

  • 50886333642521 ()
  • 00886333642526 ()

  • cable length 60"
684252

  • Electrical-only medical device connection cable, reusable
Interface cable of 150" cable length with a round shape, 4-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684243
In Commercial Distribution

  • 50886333642439 ()
  • 00886333642434 ()

  • cable length 150"
684243

  • Electrical-only medical device connection cable, reusable
Interface cable of 18" cable length with a round shape, 8-pins monitor connector.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684240
In Commercial Distribution

  • 50886333642408 ()
  • 00886333642403 ()

  • cable length 18"
684240

  • Electrical-only medical device connection cable, reusable
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, 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 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
Interface Cable to interface Transducer to Monitor. It has a 12-pin monitor connector and the cable length is 150"
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
684081
In Commercial Distribution

  • 50886333640817 ()
  • 00886333640812 ()

  • cable length 150"
684081

  • Electrical-only medical device connection cable, reusable
No Description
ALIMED, INC.
26012
In Commercial Distribution

  • 00733657277456 ()
  • 00733657299960 ()
2970000444

  • Wheelchair seat cushion
No Description
ALIMED, INC.
95-549
In Commercial Distribution

  • 00733657244670 ()
  • 00733657299601 ()
2970017537

  • Freestanding patient positioner, single-use
No Description
ALIMED, INC.
91-4108
In Commercial Distribution

  • 00733657286250 ()
  • 00733657300420 ()
2970011663

  • Freestanding patient positioner, reusable
No Description
ALIMED, INC.
7214010
In Commercial Distribution

  • 00733657286137 ()
  • 00733657300338 ()
2970009616

  • Vulnerable patient home alert system
This is a medical device.
ARIBEX, INC.
1.013.7789
In Commercial Distribution

  • EKAV101377890 ()
1.013.7789

  • Diagnostic x-ray system generator, hand-held
No Description
ALIMED, INC.
127804
In Commercial Distribution

  • 00733657287912 ()
  • 00733657300598 ()
2970000192

  • Gel-filled chair cushion
No Description
ALIMED, INC.
843110
In Commercial Distribution

  • 00733657286670 ()
  • 00733657300482 ()
2970011190

  • Wheelchair antitip device
No Description
ergoline GmbH
705780
In Commercial Distribution

  • 04059358001470 ()


  • Bicycle ergometer
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