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
Brainlab AG
2.3
Not in Commercial Distribution

  • 04056481006662 ()
25100-12

  • Radiology picture archiving and communication system workstation
BOVIE EZ LINK
BOVIE MEDICAL CORPORATION
SERS2
In Commercial Distribution

  • 10607151008496 ()
SERS2

  • Surgical plume evacuation system
SMOKE SHARK II 120V-220V - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
SE02-220
In Commercial Distribution

  • 10607151008304 ()
SE02-220

  • Surgical plume evacuation system
SMOKE SHARK II 120 V - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
SE02
In Commercial Distribution

  • 10607151008298 ()
SE02

  • Surgical plume evacuation system
PNEUMATIC FOOTSWITCH - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
FSSEP
In Commercial Distribution

  • 10607151004801 ()
FSSEP

  • Surgical plume evacuation system
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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.
PFP1X14
In Commercial Distribution

  • 00877234000645 ()

  • Width: 1 Centimeter
  • Length: 14 Centimeter
PFP1X14

  • 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.
PFP6X8
In Commercial Distribution


  • Width: 6 Centimeter
  • Length: 8 Centimeter
PFP6X8

  • 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.
PFP 6x8
In Commercial Distribution


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

  • Cardiovascular patch, animal-derived
No Description
Ad-Tech Medical Instrument Corporation
SD062-SP07X-A00
In Commercial Distribution

  • 00841823108463 ()
SD062-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
WB09R-SP00X-0B6
In Commercial Distribution

  • 00841823108432 ()
WB09R-SP00X-0B6

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
WB09R-SP00X-0AA
In Commercial Distribution

  • 00841823108425 ()
WB09R-SP00X-0AA

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
WB09R-SP00X-014
In Commercial Distribution

  • 00841823108418 ()
WB09R-SP00X-014

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
WB09R-SP00X-009
In Commercial Distribution

  • 00841823108401 ()
WB09R-SP00X-009

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
WB08R-SP00X-0AA
In Commercial Distribution

  • 00841823108395 ()
WB08R-SP00X-0AA

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

  • 00841823107862 ()
SD13R-SP45X-0T2

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

  • 00841823107848 ()
SD12R-SP10X-000

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

  • 00841823107824 ()
SD12R-SP06X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD10R-SP10X-000
In Commercial Distribution

  • 00841823107787 ()
SD10R-SP10X-000

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

  • 00841823107763 ()
SD09R-SP45X-0T0

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

  • 00841823107749 ()
SD08R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD046-SP07X-A00
In Commercial Distribution

  • 00841823107466 ()
SD046-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD044-SP07X-A00
In Commercial Distribution

  • 00841823107442 ()
SD044-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD10R-SP08X-000
In Commercial Distribution

  • 00841823107299 ()
RD10R-SP08X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD10R-SP06X-000
In Commercial Distribution

  • 00841823107275 ()
RD10R-SP06X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD10R-SP05X-0ME
In Commercial Distribution

  • 00841823107268 ()
RD10R-SP05X-0ME

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD10R-SP05X-000
In Commercial Distribution

  • 00841823107251 ()
RD10R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD10R-SP03X-000
In Commercial Distribution

  • 00841823107237 ()
RD10R-SP03X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD08R-SP05X-000
In Commercial Distribution

  • 00841823107220 ()
RD08R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD08R-SP04X-000
In Commercial Distribution

  • 00841823107213 ()
RD08R-SP04X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD06R-SP05X-000
In Commercial Distribution

  • 00841823107206 ()
RD06R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO06K-SP10X-000
In Commercial Distribution

  • 90841823103553 ()
  • 00841823103550 ()
FO06K-SP10X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO06K-SP05X-000
In Commercial Distribution

  • 90841823103546 ()
  • 00841823103543 ()
FO06K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO05K-SP05X-000
In Commercial Distribution

  • 90841823103539 ()
  • 00841823103536 ()
FO05K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO04K-SP26X-A00
In Commercial Distribution

  • 00841823103529 ()
FO04K-SP26X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO04K-SP05X-000
In Commercial Distribution

  • 90841823103515 ()
  • 00841823103512 ()
FO04K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO03K-SP05X-000
In Commercial Distribution

  • 90841823103508 ()
  • 00841823103505 ()
FO03K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FLANGE-X
In Commercial Distribution

  • 00841823103499 ()
FLANGE-X

  • Depth electrode
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
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