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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PSWTURBO 220V SMOKE EVACUATOR/FILTER/NON-STERILE TUBING
Conmed Corporation
LU3303-0257
In Commercial Distribution

  • 30845854081291 ()
LU3303-0257

  • Surgical plume evacuation system
PSWTURBO 120V SMOKE EVACUATOR/FILTER/NON-STERILE TUBING
Conmed Corporation
LU3303-0255
In Commercial Distribution

  • 30845854081130 ()
LU3303-0255

  • Surgical plume evacuation system
The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk.
tyromotion GmbH
R1
In Commercial Distribution

  • 09120077180076 ()


  • Treadmill/elliptical gait rehabilitation system
LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP YELLOW 26IN
In Commercial Distribution

  • 05050962080065 ()
HA0965

  • Movement-resistance gait rehabilitation device
LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP BLACK 26IN
In Commercial Distribution

  • 05050962023048 ()
HA0970

  • Movement-resistance gait rehabilitation device
LEEP System 1000® Smoke Evacuation System (110 VAC)
Coopersurgical, Inc.
6080-2
In Commercial Distribution

  • 00888937014440 ()


  • Surgical plume evacuation system
LEEP PRECISION™ Smoke Evacuation System (120 VAC)
Coopersurgical, Inc.
DM53502
In Commercial Distribution

  • 00888937019940 ()


  • Surgical plume evacuation system
LEEP PRECISION™ Smoke Evacuation (120 VAC)
Coopersurgical, Inc.
53502
In Commercial Distribution

  • 00888937014327 ()


  • Surgical plume evacuation system
Megadyne Laparoscopic Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
2390J
In Commercial Distribution

  • 10614559104590 ()
  • 30614559104594 ()
2390J

  • Surgical plume evacuation system
Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical
Origin Sand Spectacle
Kenmark Optical, Inc.
ORIGSA53
In Commercial Distribution

  • 00715317534734 ()


  • Prescription spectacles
Origin Sand Spectacle
Kenmark Optical, Inc.
ORIGSA51
In Commercial Distribution

  • 00715317534727 ()


  • Prescription spectacles
Origin Black Spectacle
Kenmark Optical, Inc.
ORIGBK53
In Commercial Distribution

  • 00715317534710 ()


  • Prescription spectacles
Origin Black Spectacle
Kenmark Optical, Inc.
ORIGBK51
In Commercial Distribution

  • 00715317534703 ()


  • Prescription spectacles
Origin Steel Spectacle
Kenmark Optical, Inc.
ORIGST51
In Commercial Distribution

  • 00715317534680 ()


  • Prescription spectacles
Origin Brown Spectacle
Kenmark Optical, Inc.
ORIGBR53
In Commercial Distribution

  • 00715317534673 ()


  • Prescription spectacles
Origin Brown Spectacle
Kenmark Optical, Inc.
ORIGBR51
In Commercial Distribution

  • 00715317534666 ()


  • Prescription spectacles
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)
The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M08
Not in Commercial Distribution

  • M27240M081 ()
  • 10381780034766 ()

  • Insertion needle 64mm Length


  • Depth electrode
The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
EDSEP
Not in Commercial Distribution

  • M272EDSEP1 ()
  • 10381780037088 ()


  • Depth electrode
Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
Intera Oncology Inc.
AP-03000H
In Commercial Distribution

  • 00850014110147 ()

  • Total Volume: 30 Milliliter
AP03000H

  • Implantable intrathecal infusion pump, nonprogrammable
Hemashield Woven Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000196270
In Commercial Distribution

  • 00384401018827 ()

  • Length: 15.2 Centimeter
  • Width: 5.1 Centimeter
M002000196270

  • Cardiovascular patch, animal-derived
Hemashield Woven Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000196240
In Commercial Distribution

  • 00384401018810 ()

  • Length: 7.6 Centimeter
  • Width: 5.1 Centimeter
M002000196240

  • Cardiovascular patch, animal-derived
Hemashield Woven Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000196170
In Commercial Distribution

  • 00384401018803 ()

  • Length: 152 Millimeter
  • Width: 25 Millimeter
M002000196170

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019561P0
In Commercial Distribution

  • 00384401017981 ()

  • Length: 15.2 Centimeter
  • Width: 2.5 Centimeter
M00202019561P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019530P0
In Commercial Distribution

  • 00384401017974 ()

  • Length: 7.6 Centimeter
  • Width: 2.5 Centimeter
M00202019530P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019585P0
In Commercial Distribution

  • 00384401017967 ()

  • Length: 15.2 Centimeter
  • Width: 0.8 Centimeter
M00202019585P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019579P0
In Commercial Distribution

  • 00384401017950 ()

  • Length: 7.6 Centimeter
  • Width: 0.8 Centimeter
M00202019579P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019575P0
In Commercial Distribution

  • 00384401017943 ()

  • Length: 7.6 Centimeter
  • Width: 0.6 Centimeter
M00202019575P0

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195270
In Commercial Distribution

  • 00384401017936 ()

  • Length: 15.2 Centimeter
  • Width: 5.1 Centimeter
M002000195270

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195240
In Commercial Distribution

  • 00384401017929 ()

  • Length: 7.6 Centimeter
  • Width: 5.1 Centimeter
M002000195240

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195170
In Commercial Distribution

  • 00384401017912 ()

  • Length: 15.2 Centimeter
  • Width: 2.5 Centimeter
M002000195170

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195090
In Commercial Distribution

  • 00384401017905 ()

  • Length: 7.6 Centimeter
  • Width: 0.8 Centimeter
M002000195090

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195140
In Commercial Distribution

  • 00384401017899 ()

  • Length: 7.6 Centimeter
  • Width: 2.5 Centimeter
M002000195140

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195100
In Commercial Distribution

  • 00384401017882 ()

  • Length: 15.2 Centimeter
  • Width: 0.8 Centimeter
M002000195100

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195290
In Commercial Distribution

  • 00384401017875 ()

  • Length: 7.6 Centimeter
  • Width: 0.8 Centimeter
M002000195290

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195280
In Commercial Distribution

  • 00384401017868 ()

  • Length: 12.0 Centimeter
  • Width: 0.6 Centimeter
M002000195280

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195250
In Commercial Distribution

  • 00384401017851 ()

  • Length: 7.6 Centimeter
  • Width: 0.6 Centimeter
M002000195250

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK20/140P (1)
In Commercial Distribution

  • 00384401010654 ()

  • Width: 20 Millimeter
  • Length: 140 Millimeter
HEK20/140P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Vascular Patch
INTERVASCULAR SAS
HEK10/140P (1)
In Commercial Distribution

  • 00384401007661 ()

  • Length: 140 Millimeter
  • Width: 10 Millimeter
HEK10/140P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK25/100P (1)
In Commercial Distribution

  • 00384401001591 ()

  • Length: 100 Millimeter
  • Width: 25 Millimeter
HEK25/100P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK50/50P (1)
In Commercial Distribution

  • 00384401001577 ()

  • Length: 50 Millimeter
  • Width: 50 Millimeter
HEK50/50P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK25/50P (1)
In Commercial Distribution

  • 00384401001560 ()

  • Length: 50 Millimeter
  • Width: 25 Millimeter
HEK25/50P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK100/100P (1)
In Commercial Distribution

  • 00384401001522 ()

  • Length: 100 Millimeter
  • Width: 100 Millimeter
HEK100/100P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK75/75P (1)
In Commercial Distribution

  • 00384401001515 ()

  • Length: 75 Millimeter
  • Width: 75 Millimeter
HEK75/75P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK50/150P (1)
In Commercial Distribution

  • 00384401015130 ()

  • Width: 50 Millimeter
  • Length: 150 Millimeter
HGK50/150P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK50/75P (1)
In Commercial Distribution

  • 00384401015123 ()

  • Width: 50 Millimeter
  • Length: 75 Millimeter
HGK50/75P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK25/150P (1)
In Commercial Distribution

  • 00384401015116 ()

  • Width: 25 Millimeter
  • Length: 150 Millimeter
HGK25/150P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK25/75P (1)
In Commercial Distribution

  • 00384401015024 ()

  • Width: 25 Millimeter
  • Length: 75 Millimeter
HGK25/75P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK20/140P (1)
In Commercial Distribution

  • 00384401014881 ()

  • Width: 20 Millimeter
  • Length: 140 Millimeter
HGK20/140P (1)

  • Cardiovascular patch, animal-derived
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