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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XenoSure Biologic Patch, 6cm x 8cm, eIFU
Lemaitre Vascular, Inc.
e6P8
In Commercial Distribution

  • 00840663106806 ()
e6P8

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 0.6cmx8cm
Lemaitre Vascular, Inc.
0.6BV8
In Commercial Distribution

  • 00840663106745 ()


  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1cm x 14cm, eIFU
Lemaitre Vascular, Inc.
e1P14
In Commercial Distribution

  • 00840663106356 ()
e1P14

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 10cm x 16cm, eIFU
Lemaitre Vascular, Inc.
e10P16
In Commercial Distribution

  • 00840663106349 ()
e10P16

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 8cm x 14cm, eIFU
Lemaitre Vascular, Inc.
e8P14
In Commercial Distribution

  • 00840663106332 ()
e8P14

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 4cm x 6cm, eIFU
Lemaitre Vascular, Inc.
e4P6
In Commercial Distribution

  • 00840663106325 ()
e4P6

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 4cm x 4cm, eIFU
Lemaitre Vascular, Inc.
e4P4
In Commercial Distribution

  • 00840663106318 ()
e4P4

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 2cm x 9cm, eIFU
Lemaitre Vascular, Inc.
e2P9
In Commercial Distribution

  • 00840663106301 ()
e2P9

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 0.8cm x 8cm, eIFU
Lemaitre Vascular, Inc.
e0.8P8
In Commercial Distribution

  • 00840663106295 ()
e0.8P8

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1cm x 6cm
Lemaitre Vascular, Inc.
e1P6
In Commercial Distribution

  • 00840663106288 ()
e1P6

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1cmx10cm
Lemaitre Vascular, Inc.
1BV10
In Commercial Distribution

  • 00840663106097 ()


  • Cardiovascular patch, animal-derived
Gait Trainer
RIFTON EQUIPMENT
K650
In Commercial Distribution

  • 00858101008285 ()


  • Gait rehabilitation frame, manual
Walking Harness - XXLarge - Orange Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSXXX
In Commercial Distribution

  • 00817956023126 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - XLarge - Blue Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSXX
In Commercial Distribution

  • 00817956023119 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Large - Green Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSX
In Commercial Distribution

  • 00817956023102 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Medium - Yellow Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WS
In Commercial Distribution

  • 00817956023096 ()

  • Height: 21 Inch
  • Width: 17 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
Walking Harness - Small - Red Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSP
In Commercial Distribution

  • 00817956023089 ()

  • Height: 21 Inch
  • Width: 17 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness
No Description
ALIMED, INC.
711779
In Commercial Distribution

  • 00733657216172 ()
2970008801

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
713584
In Commercial Distribution

  • 00733657274523 ()
2970009328

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711023
In Commercial Distribution

  • 00733657216127 ()
2970008693

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711029
In Commercial Distribution

  • 00733657216141 ()
2970008697

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
713583
In Commercial Distribution

  • 00733657274516 ()
2970009326

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711026
In Commercial Distribution

  • 00733657216134 ()
2970008694

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711020
In Commercial Distribution

  • 00733657216110 ()
2970008691

  • Movement-resistance gait rehabilitation device
Biovac Smoke Evacuator (120 VAC)
Coopersurgical, Inc.
909070
In Commercial Distribution

  • 00888937013986 ()


  • Surgical plume evacuation system
W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA200
In Commercial Distribution

  • 05430001477115 ()

  • Weight: 2.0 Gram


  • Dental bone matrix implant, animal-derived
W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA100
In Commercial Distribution

  • 05430001477108 ()

  • Weight: 1.0 Gram


  • Dental bone matrix implant, animal-derived
W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA050
In Commercial Distribution

  • 05430001477092 ()

  • Weight: 0.50 Gram


  • Dental bone matrix implant, animal-derived
W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA025
In Commercial Distribution

  • 05430001477085 ()

  • Weight: 0.25 Gram


  • Dental bone matrix implant, animal-derived
Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
15-40-0300
In Commercial Distribution

  • 10889981109103 ()
15-40-0300

  • Bone graft packing block
Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
14-40-0101
In Commercial Distribution

  • 10889981109059 ()
14-40-0101

  • Bone graft packing block
Graft Packer Block
SEASPINE ORTHOPEDICS CORPORATION
11-40-0101
In Commercial Distribution

  • 10889981106874 ()
11-40-0101

  • Bone graft packing block
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
31-40-0142
In Commercial Distribution

  • 10889981121471 ()
31-40-0142

  • Bone graft packing block
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
33-40-0142
In Commercial Distribution

  • 10889981160067 ()
33-40-0142

  • Bone graft packing block
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
33-40-0141
In Commercial Distribution

  • 10889981125882 ()
33-40-0141

  • Bone graft packing block
Graft Block
SEASPINE ORTHOPEDICS CORPORATION
21-40-0140
In Commercial Distribution

  • 10889981111472 ()
21-40-0140

  • Bone graft packing block
Surgical Smoke Evacuator
Buffalo Filter
VC120NF
Not in Commercial Distribution

  • 00815198012076 ()
  • 10815198012073 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator with Filter
Buffalo Filter
VC120
Not in Commercial Distribution

  • 00815198012069 ()
  • 10815198012066 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
VV120NF
Not in Commercial Distribution

  • 00851136002853 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator with ViroVac Filter
Buffalo Filter
VV120
Not in Commercial Distribution

  • 00851136002815 ()


  • Surgical plume evacuation system
Surgical Smoke Evacuator
Buffalo Filter
DKVV120
Not in Commercial Distribution

  • 00815198011994 ()


  • Surgical plume evacuation system
Wall Mount Kit
Buffalo Filter
VVWM01
Not in Commercial Distribution

  • 00815198012168 ()


  • Surgical plume evacuation system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000YT
In Commercial Distribution

  • 00840682121644 ()


  • Stationary gamma camera system
No Description
Innosys Co., Ltd.
TL0520
In Commercial Distribution

  • 08800015995474 ()


  • Bone graft packing block
No Description
Innosys Co., Ltd.
PL0450
In Commercial Distribution

  • 08800015954730 ()


  • Bone graft packing block
Vector Gait and Safety System
BIONESS INC.
VEC-1000
In Commercial Distribution

  • 00815962020269 ()


  • Gait rehabilitation frame, electric
Vector Trolley Assembly, Elite Model
BIONESS INC.
VEC-1100
In Commercial Distribution

  • 00815962020276 ()


  • Gait rehabilitation frame, electric
Vector Gait and Safety System, Base Model
BIONESS INC.
VEC-3000
In Commercial Distribution

  • 00815962020283 ()


  • Gait rehabilitation frame, manual
The VascuCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UV2080
In Commercial Distribution

  • 09348992000693 ()

  • Width: 2 Centimeter
  • Length: 8 Centimeter
V2080

  • Cardiovascular patch, animal-derived
The VascuCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using ADAPT TEP technology. It is a sterile, off-white, moist, pre-cut, flat sheet of acellular collagen.
ADMEDUS REGEN PTY LTD
UV1014
In Commercial Distribution

  • 09348992000686 ()

  • Length: 14 Centimeter
  • Width: 1 Centimeter
V1014

  • Cardiovascular patch, animal-derived
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