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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The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders.
tyromotion GmbH
1
In Commercial Distribution

  • 09120077180083 ()


  • Treadmill/elliptical gait rehabilitation 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
The gait trainer conveys mechanical energy needed to perform gait therapy via foot plates to the sole of the patient’s feet. The foot plates follow a pattern that is derived from healthy subjects. The body weight support system secures the patient from falling and further allows to reduce the weight on the patient’s feet.
medica - Medizintechnik GmbH
01.XX.XX
In Commercial Distribution

  • 04041925002775 ()


  • Treadmill/elliptical gait rehabilitation system
icotec Lumbar Cage, Implant Holder for Tamping
icotec AG
38-036
In Commercial Distribution

  • 07640164841830 ()
38-036

  • Bone graft packing block
Custom Finish (SP-XXXX)
Zoll-Dental
GP-SP
In Commercial Distribution

  • 00840105205647 ()


  • Bone graft packing block
6.0mm/8.0mm Smooth
Zoll-Dental
GP-6.0/8.0SM
In Commercial Distribution

  • 00840105205623 ()


  • Bone graft packing block
6.0mm/8.0mm Serrated
Zoll-Dental
GP-6.0/8.0SER
In Commercial Distribution

  • 00840105205616 ()


  • Bone graft packing block
5.0mm/5.5mm Smooth
Zoll-Dental
GP-5.0/5.5SM
In Commercial Distribution

  • 00840105205609 ()


  • Bone graft packing block
5.0mm/5.5mm Serrated
Zoll-Dental
GP-5.0/5.5SER
In Commercial Distribution

  • 00840105205593 ()


  • Bone graft packing block
4.2mm/4.8mm Smooth
Zoll-Dental
GP-4.2/4.8SM
In Commercial Distribution

  • 00840105205586 ()


  • Bone graft packing block
4.2mm/4.8mm Serrated
Zoll-Dental
GP-4.2/4.8SER
In Commercial Distribution

  • 00840105205579 ()


  • Bone graft packing block
3.2mm/3.8mm Smooth
Zoll-Dental
GP-3.2/3.8SM
In Commercial Distribution

  • 00840105205562 ()


  • Bone graft packing block
3.2mm/3.8mm Serrated
Zoll-Dental
GP-3.2/3.8SER
In Commercial Distribution

  • 00840105205555 ()


  • Bone graft packing block
1.8mm/2.8mm Smooth
Zoll-Dental
GP-1.8/2.8SM
In Commercial Distribution

  • 00840105205548 ()


  • Bone graft packing block
1.8mm/2.8mm Serrated
Zoll-Dental
GP-1.8/2.8SER
In Commercial Distribution

  • 00840105205531 ()


  • Bone graft packing block
1.5mm/1.8mm Smooth
Zoll-Dental
GP-1.5/1.8SM
In Commercial Distribution

  • 00840105205524 ()


  • Bone graft packing block
1.5mm/1.8mm Serrated
Zoll-Dental
GP-1.5/1.8SER
In Commercial Distribution

  • 00840105205517 ()


  • Bone graft packing block
Moody 5.0mm
Zoll-Dental
GP-Moody-5.0
In Commercial Distribution

  • 00840105222132 ()


  • Bone graft packing block
Moody 4.0mm
Zoll-Dental
GP-Moody-4.0
In Commercial Distribution

  • 00840105222125 ()


  • Bone graft packing block
Moody 3.0mm
Zoll-Dental
GP-Moody-3.0
In Commercial Distribution

  • 00840105222118 ()


  • Bone graft packing block
Graft Packer/Plugger
Zoll-Dental
Z-7223
In Commercial Distribution

  • 00840105220503 ()


  • Bone graft packing block
Graft Packer/Plugger
Zoll-Dental
Z-7222
In Commercial Distribution

  • 00840105220497 ()


  • Bone graft packing block
Graft Packer/Plugger
Zoll-Dental
Z-7221
In Commercial Distribution

  • 00840105220480 ()


  • Bone graft packing block
Graft Packer/Plugger
Zoll-Dental
Z-7220
In Commercial Distribution

  • 00840105220473 ()


  • Bone graft packing block
The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
WANDERCRAFT
ATA-002-EN US
In Commercial Distribution

  • 03665965000129 ()


  • Programmable ambulation exoskeleton, clinical
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003010 ()
403507

  • Intraurethral valve/pump
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003001 ()
403507

  • Intraurethral valve/pump
Magnetic shield for the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003191 ()
403350

  • Intraurethral valve/pump
Magnetic remote control for the inFlow Device - with base station and medical charger
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003184 ()
403507K

  • Intraurethral valve/pump
Recharger for inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003177 ()
403320

  • Intraurethral valve/pump
Unit for storing and recharging the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003160 ()
403310

  • Intraurethral valve/pump
Magnetic remote control for the inFlow Device
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003153 ()
403300

  • Intraurethral valve/pump
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution

  • W41020AU201S1969 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
Smoke Filtration System (230 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
230VAC
In Commercial Distribution

  • H671SSE2000 ()
SSE-200

  • Surgical plume evacuation system
Smoke Filtration System (115 Volts AC)
UTAH MEDICAL PRODUCTS, INC.
115VAC
In Commercial Distribution

  • H671SSE1000 ()
SSE-100

  • Surgical plume evacuation system
Trexo Robotics XL Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321072 ()

  • XL
A001BPX

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Large Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321065 ()

  • Large
A001BPR

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Medium Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321058 ()

  • Medium
A001BPR

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Small Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321041 ()

  • Small
A001BPR

  • Programmable ambulation exoskeleton, clinical
Graft Packing & Screw Reference Block
TITAN SPINE, LLC
5210-1017
Not in Commercial Distribution

  • 00191375028345 ()

  • Height: 1 Inch
  • Width: 2 Inch
  • Length: 1.5 Inch
5210-1017

  • Bone graft packing block
Graft Packing & Screw Reference Block
TITAN SPINE, LLC
2300-1317
Not in Commercial Distribution

  • 00191375028338 ()

  • Width: 1.5 Inch
  • Length: 2 Inch
  • Height: 1.25 Inch
2300-1317

  • Bone graft packing block
Iris Straight Bipolar Forcep 3 1/2" (88.9mm) Insulated With A (High Polished 10mm Long Area) With A 0.5mm Tip Country Of Origin USA
TITAN MANUFACTURING INC
160818205030101
In Commercial Distribution

  • 00817914024905 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Yasargil Bayonet Bipolar Forcep 7 7/8" (200.03mm) Insulated With A (High Polished 10mm Long Area) With A 1.3mm Tip Anti-Stick Country of Origin: USA
TITAN MANUFACTURING INC
163128240070101
In Commercial Distribution

  • 00817914024882 ()

  • Length: 200.03 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Blue Titanium Square Grip Handle Bayonet Bipolar Forcep 8 3/4" (222.25mm) Insulated With A (High Polished 10mm Long Area) With A 1.5mm Tip, Anti-Stick Country of Origin: USA
TITAN MANUFACTURING INC
183928147080101
In Commercial Distribution

  • 00817914024875 ()

  • Length: 222.25 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
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
BIOFEEDBACK DEVICE BioRef-DC
TAVGER LTD
FG00019
In Commercial Distribution

  • 07290017249049 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
ACF GRAFT PACKING BLOCK
Synthes GmbH
396.996
In Commercial Distribution

  • H9813969960 ()
  • 10705034778204 ()
396996

  • Bone graft packing block
ALIF GRAFT PACKING BLOCK
Synthes GmbH
389.155
In Commercial Distribution

  • H9813891550 ()
  • 10705034774800 ()
389155

  • Bone graft packing block
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