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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JBAIDS IVD Influenza A Subtyping Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0138
Not in Commercial Distribution

  • 00851458005075 ()
JRPD-ASY-0138

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical
60" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB60QRNRB
In Commercial Distribution

  • 00840216113978 ()


  • Gait rehabilitation system harness
Decellularized Bovine Pericardium
Artivion, Inc.
PFP2X9
In Commercial Distribution

  • 00877234000652 ()

  • Width: 2 Centimeter
  • Length: 9 Centimeter
PFP2X9

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Artivion, Inc.
PFP1X10
In Commercial Distribution

  • 00877234000638 ()

  • Width: 1 Centimeter
  • Length: 10 Centimeter
PFP1X10

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Artivion, Inc.
PFP8X14
In Commercial Distribution

  • 00877234000560 ()

  • Width: 8 Centimeter
  • Length: 14 Centimeter
PFP8X14

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Artivion, Inc.
PFP0.8X8
In Commercial Distribution

  • 00877234000553 ()

  • Width: 0.8 Centimeter
  • Length: 8 Centimeter
PFP0.8X8

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Artivion, Inc.
PFP4X4
In Commercial Distribution

  • 00877234000546 ()

  • Width: 4 Centimeter
  • Length: 4 Centimeter
PFP4X4

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Artivion, Inc.
PFP1X6
In Commercial Distribution

  • 00877234000539 ()

  • Width: 1 Centimeter
  • Length: 6 Centimeter
PFP1X6

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Artivion, Inc.
PFP1X14
In Commercial Distribution

  • 00877234000645 ()

  • Width: 1 Centimeter
  • Length: 14 Centimeter
PFP1X14

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Artivion, Inc.
PFP6X8
In Commercial Distribution


  • Width: 6 Centimeter
  • Length: 8 Centimeter
PFP6X8

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
Artivion, Inc.
PFP 6x8
In Commercial Distribution


  • Width: 6 Centimeter
  • Length: 8 Centimeter
PFP 6x8

  • Cardiovascular patch, animal-derived
No Description
Ad-Tech Medical Instrument Corporation
MM31A-SP53X-000
In Commercial Distribution

  • 00841823109576 ()
MM31A-SP53X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
MM29A-SP52X-000
In Commercial Distribution

  • 00841823109569 ()
MM29A-SP52X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
MM32D-SP05X-000
In Commercial Distribution

  • 00841823109552 ()
MM32D-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD07R-SP45X-0T0
In Commercial Distribution

  • 00841823109514 ()
SD07R-SP45X-0T0

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP45X-000
In Commercial Distribution

  • 00841823109507 ()
SD06R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD16R-SP05X-000
In Commercial Distribution

  • 00841823109491 ()
SD16R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP45X-0T1
In Commercial Distribution

  • 00841823109484 ()
SD14R-SP45X-0T1

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP05X-000
In Commercial Distribution

  • 00841823109477 ()
SD14R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP03X-000
In Commercial Distribution

  • 00841823109460 ()
SD14R-SP03X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD13R-SP45X-0T2
In Commercial Distribution

  • 00841823109453 ()
SD13R-SP45X-0T2

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP45X-000
In Commercial Distribution

  • 00841823109446 ()
SD12R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP10X-000
In Commercial Distribution

  • 00841823109439 ()
SD12R-SP10X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP09X-000
In Commercial Distribution

  • 00841823109422 ()
SD12R-SP09X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP06X-000
In Commercial Distribution

  • 00841823109415 ()
SD12R-SP06X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP05X-000
In Commercial Distribution

  • 00841823109408 ()
SD12R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP03X-000
In Commercial Distribution

  • 00841823109392 ()
SD12R-SP03X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD11R-SP45X-0T0
In Commercial Distribution

  • 00841823109385 ()
SD11R-SP45X-0T0

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD10R-SP45X-000
In Commercial Distribution

  • 00841823109378 ()
SD10R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD10R-SP05X-000
In Commercial Distribution

  • 00841823109354 ()
SD10R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD10R-SP03X-000
In Commercial Distribution

  • 00841823109347 ()
SD10R-SP03X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD09R-SP45X-0T0
In Commercial Distribution

  • 00841823109330 ()
SD09R-SP45X-0T0

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD08R-SP45X-000
In Commercial Distribution

  • 00841823109323 ()
SD08R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD08R-SP10X-AN1
In Commercial Distribution

  • 00841823109316 ()
SD08R-SP10X-AN1

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD08R-SP10X-000
In Commercial Distribution

  • 00841823109309 ()
SD08R-SP10X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD08R-SP07X-A00
In Commercial Distribution

  • 00841823109293 ()
SD08R-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD08R-SP05X-000
In Commercial Distribution

  • 00841823109286 ()
SD08R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP59X-000
In Commercial Distribution

  • 00841823109262 ()
SD06R-SP59X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP10X-000
In Commercial Distribution

  • 00841823109248 ()
SD06R-SP10X-000

  • Depth electrode
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