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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DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-04-053
In Commercial Distribution

  • 00650551040200 ()

  • Contact Length 2 Millimeter
  • Main Tube Length 35 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 17 Millimeter
2102-04-053

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-04-037
In Commercial Distribution

  • 00650551040194 ()

  • Contact Length 2 Millimeter
  • Main Tube Length 36 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 17 Millimeter
2102-04-037

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-04-036
In Commercial Distribution

  • 00650551040187 ()

  • Recording Depth 17 Millimeter
  • Spacing 5 Millimeter
  • Main Tube Length 36 Centimeter
  • Contact Length 2 Millimeter
2102-04-036

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-04-031
In Commercial Distribution

  • 00650551040170 ()

  • Main Tube Length 20 Centimeter
  • Recording Depth 17 Millimeter
  • Spacing 5 Millimeter
  • Contact Length 2 Millimeter
2102-04-031

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR, MEG 2
PMT CORPORATION
2102-04-023M2
In Commercial Distribution

  • 00650551040163 ()

  • Contact Length 2 Millimeter
  • Main Tube Length 67 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 17 Millimeter
2102-04-023M2

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-04-007
In Commercial Distribution

  • 00650551040156 ()

  • Contact Length 2 Millimeter
  • Main Tube Length 36 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 17 Millimeter
2102-04-007

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-04-001
In Commercial Distribution

  • 00650551040149 ()

  • Recording Depth 17 Millimeter
  • Spacing 5 Millimeter
  • Main Tube Length 36 Centimeter
  • Contact Length 2 Millimeter
2102-04-001

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 3 CONTACT, MINI CONNECTOR
PMT CORPORATION
2102-03-082
In Commercial Distribution

  • 00650551040132 ()

  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
  • Spacing 10 Millimeter
  • Recording Depth 25 Millimeter
2102-03-082

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 2 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-02-IL-SS
In Commercial Distribution

  • 00650551040125 ()

  • Recording Depth 15 Millimeter
  • Spacing 10 Millimeter
  • Main Tube Length 32 Centimeter
  • Contact Length 5 Millimeter
2102-02-IL-SS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 2 CONTACT (2MM), INLINE CONNECTOR
PMT CORPORATION
2102-02-121
In Commercial Distribution

  • 00650551040118 ()

  • Spacing: 10 Millimeter
  • Outer Diameter: 1.8 Millimeter
  • Recording Depth: 12 Millimeter
2102-02-121

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 2 CONTACT (2MM), INLINE CONNECTOR
PMT CORPORATION
2102-02-120
In Commercial Distribution

  • 00650551040101 ()

  • Recording Depth: 7 Millimeter
  • Outer Diameter: 1.8 Millimeter
  • Spacing: 5 Millimeter
2102-02-120

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 2 CONTACT, IOM CONNECTOR
PMT CORPORATION
2102-02-077
In Commercial Distribution

  • 00650551040095 ()

  • Recording Depth 17 Millimeter
  • Contact Length 2 Millimeter
  • Spacing 15 Millimeter
2102-02-077

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, TIP ONLY, IOM CONNECTOR
PMT CORPORATION
2102-01-078
In Commercial Distribution

  • 00650551040088 ()

  • Contact Length 2 Millimeter
  • Main Tube Length 32 Centimeter
2102-01-078

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, TIP ONLY, INLINE CONNECTOR
PMT CORPORATION
2102-01-037
In Commercial Distribution

  • 00650551040071 ()

  • Contact Length 2 Millimeter
  • Main Tube Length 36 Centimeter
2102-01-037

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, TIP ONLY, INLINE CONNECTOR
PMT CORPORATION
2102-01-032
In Commercial Distribution

  • 00650551040064 ()

  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
2102-01-032

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, TIP ONLY, MINI CONNECTOR
PMT CORPORATION
2102-01-012
In Commercial Distribution

  • 00650551040057 ()

  • Main Tube Length 32 Centimeter
  • Contact Length 5 Millimeter
2102-01-012

  • Depth electrode
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
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
BIOFEEDBACK DEVICE BioRef-DC
TAVGER LTD
FG00019
In Commercial Distribution

  • 07290017249049 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • 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

  • 08625630003010 ()
403507

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003003 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003002 ()

  • Length: 60 Millimeter
  • Length: 55 Millimeter
  • Length: 50 Millimeter
  • Length: 45 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
203511

  • 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
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump
Device for oocyte collection
LABORATOIRE CCD
HOC COLLECTION VIAL 30ML
In Commercial Distribution

  • 03700111425866 ()
  • 03700111400863 ()

  • Total Volume: 30 Milliliter
1302001

  • Assisted reproduction cryotube
Number of legs: Double Leg length: eXtra long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DXWUS
In Commercial Distribution

  • 04560340091091 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DLWUS
In Commercial Distribution

  • 04560340091084 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Medium Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DMWUS
In Commercial Distribution

  • 04560340091077 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Short Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DSWUS
In Commercial Distribution

  • 04560340091060 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: eXtra long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DXMUS
In Commercial Distribution

  • 04560340090971 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DLMUS
In Commercial Distribution

  • 04560340090964 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Medium Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DMMUS
In Commercial Distribution

  • 04560340090957 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Short Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DSMUS
In Commercial Distribution

  • 04560340090940 ()


  • Neuro-controlled ambulation exoskeleton
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-02
In Commercial Distribution

  • 00850005539025 ()


  • Neuro-controlled joint movement exoskeleton
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-01
In Commercial Distribution

  • 00850005539018 ()


  • Neuro-controlled joint movement exoskeleton
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
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