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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Safety Box 0.2L
NITTA M&T (THAILAND) COMPANY LIMITED
NT-008_RC
In Commercial Distribution

  • 08859807700024 ()


  • Sharps container
Safety Box 0.2L
NITTA M&T (THAILAND) COMPANY LIMITED
NT-008_PC
In Commercial Distribution

  • 08859807700017 ()


  • Sharps container
No Description
IT-V Medizintechnik GmbH
P10107-852
In Commercial Distribution

  • 09120074398528 ()


  • Radiological whole-body positioner
No Description
IT-V Medizintechnik GmbH
P10107-850
Not in Commercial Distribution

  • 09120074398504 ()


  • Radiological whole-body positioner
No Description
IT-V Medizintechnik GmbH
P10107-534
In Commercial Distribution

  • 09120074395343 ()


  • Radiological whole-body positioner
This is a medical device.This is a medical device.
KaVo Dental GmbH
0.535.5250
In Commercial Distribution

  • EKAV053552500 ()
181 M

  • Dental surgical power tool motor, pneumatic
No Description
KaVo Dental GmbH
1.011.1800
In Commercial Distribution

  • EKAV101118000 ()
M/C

  • Dental delivery system
No Description
BIOCARE MEDICAL LLC
ACI3114B
In Commercial Distribution

  • 00847627002990 ()


  • Melan-A/MART-1 peptide IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3114A
In Commercial Distribution

  • 00847627002983 ()


  • Melan-A/MART-1 peptide IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3114AA
In Commercial Distribution

  • 00847627004192 ()


  • Melan-A/MART-1 peptide IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3017AAK
In Commercial Distribution

  • 00847627003928 ()


  • ETS-related gene (ERG) protein IVD, antibody
Holder to fix the Biopsy Needle
FUJIFILM CORPORATION
NEEDLE HOLDER M E
In Commercial Distribution

  • 04547410143089 ()


  • Stationary mammographic x-ray system, digital
Adjust the depth that the needle is inserted. The slide stopper differs for each needle. Use a slide stopper that suits each type of needle being used.
FUJIFILM CORPORATION
LATERAL NEEDLE STOPPER M E
In Commercial Distribution

  • 04547410211337 ()


  • Stationary mammographic x-ray system, digital
Lancing Device
BIOTEST MEDICAL CORPORATION
8228
In Commercial Distribution

  • 04719871820049 ()


  • Home-use/point-of-care blood glucose monitoring system IVD
No Description
EVIDENT CORPORATION
IX3-CBM
In Commercial Distribution



  • Inverted-stage light microscope
No Description
Biomet Orthopedics, LLC
32-423139
In Commercial Distribution

  • 00887868485473 ()

  • Size E
32-423139

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
32-423138
In Commercial Distribution

  • 00887868485466 ()

  • Size E
32-423138

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
32-423137
In Commercial Distribution

  • 00887868485459 ()

  • Size D
32-423137

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
32-423136
In Commercial Distribution

  • 00887868485442 ()

  • Size D
32-423136

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
32-423135
In Commercial Distribution

  • 00887868485435 ()

  • Size C
32-423135

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
32-423134
In Commercial Distribution

  • 00887868485428 ()

  • Size C
32-423134

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
32-423133
In Commercial Distribution

  • 00887868485411 ()

  • Size B
32-423133

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
32-423132
In Commercial Distribution

  • 00887868485404 ()

  • Size B
32-423132

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
32-423131
In Commercial Distribution

  • 00887868485398 ()

  • Size A
32-423131

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
32-423130
In Commercial Distribution

  • 00887868485381 ()

  • Size A
32-423130

  • Surgical implant template, reusable
No Description
Biomet Orthopedics, LLC
32-423124
In Commercial Distribution

  • 00887868485374 ()

  • Size E8
32-423124

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423123
In Commercial Distribution

  • 00887868485367 ()

  • Size E7
32-423123

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423122
In Commercial Distribution

  • 00887868485350 ()

  • Size E6
32-423122

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423121
In Commercial Distribution

  • 00887868485343 ()

  • Size E5
32-423121

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423120
In Commercial Distribution

  • 00887868485336 ()

  • Size E4
32-423120

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423119
In Commercial Distribution

  • 00887868485329 ()

  • Size D8
32-423119

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423118
In Commercial Distribution

  • 00887868485312 ()

  • Size D7
32-423118

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423117
In Commercial Distribution

  • 00887868485305 ()

  • Size D6
32-423117

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423116
In Commercial Distribution

  • 00887868485299 ()

  • Size D5
32-423116

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423115
In Commercial Distribution

  • 00887868485282 ()

  • Size D4
32-423115

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423114
In Commercial Distribution

  • 00887868485275 ()

  • Size C8
32-423114

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423113
In Commercial Distribution

  • 00887868485268 ()

  • Size C7
32-423113

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423112
In Commercial Distribution

  • 00887868485251 ()

  • Size C6
32-423112

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423111
In Commercial Distribution

  • 00887868485244 ()

  • Size C5
32-423111

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423110
In Commercial Distribution

  • 00887868485237 ()

  • Size C4
32-423110

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423109
In Commercial Distribution

  • 00887868485220 ()

  • Size B8
32-423109

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423108
In Commercial Distribution

  • 00887868485213 ()

  • Size B7
32-423108

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423107
In Commercial Distribution

  • 00887868485206 ()

  • Size B6
32-423107

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423106
In Commercial Distribution

  • 00887868485190 ()

  • Size B5
32-423106

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423105
In Commercial Distribution

  • 00887868485183 ()

  • Size B4
32-423105

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423104
In Commercial Distribution

  • 00887868485176 ()

  • Size A8
32-423104

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423103
In Commercial Distribution

  • 00887868485169 ()

  • Size A7
32-423103

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423102
In Commercial Distribution

  • 00887868485152 ()

  • Size A6
32-423102

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423101
In Commercial Distribution

  • 00887868485145 ()

  • Size A5
32-423101

  • Knee tibia prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-423100
In Commercial Distribution

  • 00887868485138 ()

  • Size A4
32-423100

  • Orthopaedic reamer guide
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