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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V-Trak
MICROVENTION INC.
8110-1026
In Commercial Distribution

  • 00811425028209 ()

  • 10 mm x 26 cm
8110-1026

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
8110-0820
In Commercial Distribution

  • 00811425028186 ()

  • 8 mm x 20 cm
8110-0820

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
8110-0615
In Commercial Distribution

  • 00811425028162 ()

  • 6 mm x 15 cm
8110-0615

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
8110-0204
In Commercial Distribution

  • 00811425028124 ()

  • 2 mm x 4 cm
8110-0204

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100817HFRM-V-A
In Commercial Distribution

  • 00811425027172 ()

  • 8 mm x 17 cm
100817HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100728HFRM-V-A
In Commercial Distribution

  • 00811425027165 ()

  • 7 mm x 28 cm
100728HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100715HFRM-V-A
In Commercial Distribution

  • 00811425027141 ()

  • 7 mm x 15 cm
100715HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100619HFRM-V-A
In Commercial Distribution

  • 00811425027127 ()

  • 6 mm x 19 cm
100619HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100612HFRM-V-A
In Commercial Distribution

  • 00811425027110 ()

  • 6 mm x 12 cm
100612HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100515HFRM-V-A
In Commercial Distribution

  • 00811425027097 ()

  • 5 mm x 15 cm
100515HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100510HFRM-V-A
In Commercial Distribution

  • 00811425027080 ()

  • 5 mm x 10 cm
100510HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100408HFRM-V-A
In Commercial Distribution

  • 00811425027066 ()

  • 4 mm x 8 cm
100408HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100405HFRM-V-A
In Commercial Distribution

  • 00811425027059 ()

  • 4 mm x 5 cm
100405HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100306HFRM-V-A
In Commercial Distribution

  • 00811425027042 ()

  • 3 mm x 6 cm
100306HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100254HFRM-V-A
In Commercial Distribution

  • 00811425027035 ()

  • 2.5 mm x 4 cm
100254HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100202HFRM-V-A
In Commercial Distribution

  • 00811425027028 ()

  • 2 mm x 2 cm
100202HFRM-V

  • Neurovascular embolization coil
DrugSmart Cup 10, AMP/COC/THC/OPI2000/MET/PCP/BAR/BZO/MTD/OXY + (Cr/SG/Ox)(Ni/pH/Gl)
CHEMTRON BIOTECH INC
61020D-6AB
In Commercial Distribution

  • 00812203030612 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
HME
Pharma Systems Ps AB
6063
In Commercial Distribution

  • 30734000671373 ()

  • Length: 7.0 Centimeter
6063

  • Heat/moisture exchanger, single-use
HME
Pharma Systems Ps AB
6060
In Commercial Distribution

  • 30734000671342 ()

  • Length: 7.3 Centimeter
6060

  • Electrocautery system generator, line-powered
No Description
CareDx AB
101.129-06u
In Commercial Distribution

  • 07340035500483 ()


  • HLA class II antigen tissue typing IVD, kit, multiplex
10 MHz probe is an ultrasonic transducer that generates acoustic signals and also detects returned signals, intended to be used in combination with the Falcon system for noninvasive peripheral vascular measurements.
VIASONIX LTD
10 MHz probe
Not in Commercial Distribution

  • 07290016880410 ()
PVC0332

  • General-purpose ultrasound imaging system
10 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the FALCON system for noninvasive measurements of blood flow velocities in arteries and veins
VIASONIX LTD
10 MHz probe
Not in Commercial Distribution

  • 07290016880076 ()


  • General-purpose ultrasound imaging system
1.2ML
PEARSON DENTAL SUPPLIES, INC.
z060324
In Commercial Distribution

  • D724Z0603241 ()
  • D724Z0303242 ()


  • Dental etching solution
Halliburton - 10 Metal
Certified Safety Manufacturing, Inc.
K208-177
In Commercial Distribution

  • 00766588081779 ()
K208-177

  • First aid kit, medicated
The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon. The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Front Line Medical Technologies Inc.
E01P3
Not in Commercial Distribution

  • 16286780610023 ()

  • Total Volume: 10 Milliliter
E01P3

  • General-purpose syringe, single-use
Reducer-sleeve,10/5mm
mahe medical gmbh
13.070.10
In Commercial Distribution

  • EMAH13070101 ()
  • EMAH13070100 ()
13.070.10

  • Laparoscopic access cannula, reusable
Treatment table
Lojer Oy
Manuthera 242
In Commercial Distribution

  • 06430021930668 ()
Manuthera 242

  • Examination/treatment table, line-powered
Treatment table
Lojer Oy
Capre FX5
In Commercial Distribution

  • 06430021930576 ()
Capre FX5

  • Examination/treatment table, line-powered
Treatment table
Lojer Oy
Capre FX3
In Commercial Distribution

  • 06430021930569 ()
Capre FX3

  • Examination/treatment table, line-powered
Treatment table
Lojer Oy
Capre F5 AM
In Commercial Distribution

  • 06430021930538 ()
Capre F5 AM

  • Examination/treatment table, line-powered
Treatment table
Lojer Oy
Capre F5
In Commercial Distribution

  • 06430021930521 ()
Capre F5

  • Examination/treatment table, line-powered
Treatment table
Lojer Oy
Capre F3
In Commercial Distribution

  • 06430021930514 ()
Capre F3

  • Examination/treatment table, line-powered
Treatment table
Lojer Oy
Capre F2
In Commercial Distribution

  • 06430021930507 ()
Capre F2

  • Examination/treatment table, line-powered
Treatment table
Lojer Oy
Capre M4 AM
In Commercial Distribution

  • 06430021930477 ()
Capre M4 AM

  • Examination/treatment table, line-powered
Treatment table
Lojer Oy
Capre M4
In Commercial Distribution

  • 06430021930460 ()
Capre M4

  • Examination/treatment table, line-powered
Treatment table
Lojer Oy
Capre M2
In Commercial Distribution

  • 06430021930453 ()
Capre M2

  • Examination/treatment table, line-powered
The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of fracture and/or creation of a void in cancellous bone in the spine.
BM KOREA CO., LTD
BMK(T)15αS
In Commercial Distribution

  • 08809255544633 ()
  • 08809255542639 ()


  • Catheter/overtube balloon inflator, single-use
The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of fracture and/or creation of a void in cancellous bone in the spine.
BM KOREA CO., LTD
2BMK(T)15αS
In Commercial Distribution

  • 08809255540987 ()

  • Length: 15 Millimeter


  • Catheter/overtube balloon inflator, single-use
S/ETCH JUMBO 2X25ML SYR
SDI LIMITED
8100059
In Commercial Distribution

  • 09336472012052 ()
8100059

  • Dental etching solution
S/ETCH 12GM SYR WITH TIPS
SDI LIMITED
8100052
In Commercial Distribution

  • 09336472012007 ()
8100052

  • Dental etching solution
S/ETCH 10X2ML SYR KT
SDI LIMITED
8100045
In Commercial Distribution

  • 09336472011963 ()
8100045

  • Dental etching solution
S/ETCH 3X2ML SYR KT
SDI LIMITED
8100040
In Commercial Distribution

  • 09336472011932 ()
8100040

  • Dental etching solution
MODEL 5004, 110V
ORMCO CORPORATION
973-0212
In Commercial Distribution

  • 00889989069532 ()


  • Endodontic filling material condenser
Heat Source, Model 1005
ORMCO CORPORATION
952-0001
In Commercial Distribution

  • 00889989068412 ()


  • Endodontic filling material condenser
ELEMENTS DIAGNOSTIC UNIT W/O SATELLITE
ORMCO CORPORATION
973-0320
In Commercial Distribution

  • 00889989061888 ()


  • Dental pulp analysis system
ELEMENTS DIAGNOSTIC UNIT
ORMCO CORPORATION
973-0300
In Commercial Distribution

  • 00889989061871 ()


  • Dental pulp analysis system
VITALITY SCANNER 2006
ORMCO CORPORATION
973-0234
Not in Commercial Distribution

  • 00889989069709 ()


  • Dental pulp analysis system
No Description
MANUKAMED LIMITED PARTNERSHIP
MM0032
Not in Commercial Distribution

  • 05060188820147 ()
  • 05060188820130 ()


  • Exudate-absorbent dressing, non-gel, antimicrobial
mrdh Bandage 10 cm x 10 cm (4" x 4")
Marine Polymer Technologies, Inc.
400-14
In Commercial Distribution

  • 10389142000114 ()
  • 00389142000117 ()


  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
No Description
Drägerwerk AG & Co. KGaA
8418458
In Commercial Distribution

  • 04048675028642 ()


  • Ventilator breathing circuit, reusable
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