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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microTargeting(TM) Electrode, 6x, non-sterile, D.ZAP(L), for use with Nexframe(R) and STar Drive
FHC, INC.
5735L-00580
In Commercial Distribution

  • 10873263005801 ()
  • 00873263005804 ()

  • Length: 242.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 227.2 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
5735L

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, for use with Nexframe(R)
FHC, INC.
5030R-00575
In Commercial Distribution

  • 10873263005757 ()
  • 00873263005750 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Length: 234.2 Millimeter
5030R

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, single, for use with Platform
FHC, INC.
44930R-00572
In Commercial Distribution

  • 10873263005726 ()
  • 00873263005729 ()

  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 220.7 Millimeter
  • Length: 205.7 Millimeter
44930R

  • Depth electrode
microTargeting(TM) Electrode, differential, nonsterile
FHC, INC.
MTDPXN(EP)(BP8)-00570
In Commercial Distribution

  • 10873263005702 ()
  • 00873263005705 ()

  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Outer Diameter: 0.86 Millimeter
  • Length: 3 Millimeter
MTDPXN(EP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BS)(FM2)-00534
In Commercial Distribution

  • 10873263005344 ()
  • 00873263005347 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 2 Millimeter
  • Length: 93 Millimeter
  • Length: 100 Millimeter
  • Impedance: Megaohms
MTDWLN(BS)(FM2)

  • Depth electrode
microTargeting(TM) Electrode, side by side, tungsten, DZAP(L), nonsterile
FHC, INC.
MTTWLN(ZK2)-00517
In Commercial Distribution

  • 10873263005177 ()
  • 00873263005170 ()

  • Length: 252 Millimeter
  • Impedance: Megaohms
MTTWLN(ZK2)

  • Depth electrode
microTargeting(TM) Electrode, shielded, tungsten, nonsterile, 6x
FHC, INC.
MTSWBN(LX1)-00488
In Commercial Distribution

  • 10873263004880 ()
  • 00873263004883 ()

  • Outer Diameter: 1.24 Millimeter
  • Impedance: Megaohms
  • Length: 50 Millimeter
  • Length: 193 Millimeter
  • Length: 49 Millimeter
  • Length: 246 Millimeter
MTSWBN(LX1)

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-07-NS
In Commercial Distribution

  • 00650551092988 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.03125 Inch
2102-32-07-NS

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-06-NS
In Commercial Distribution

  • 00650551092971 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-06-NS

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-01-NS
In Commercial Distribution

  • 10650551092947 ()
  • 00650551092940 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-32-01-NS

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
PMT CORPORATION
2102-31-01-NS
In Commercial Distribution

  • 10650551092923 ()
  • 00650551092926 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-31-01-NS

  • Depth electrode
STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-01-NS
In Commercial Distribution

  • 10650551092909 ()
  • 00650551092902 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-32-01-NS

  • Depth electrode
STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
PMT CORPORATION
2101-31-01-NS
In Commercial Distribution

  • 10650551092886 ()
  • 00650551092889 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-31-01-NS

  • Depth electrode
CRIMPING TOOL FOR NON-CRIMPED SPHENOIDAL ELECTRODE
PMT CORPORATION
2105
In Commercial Distribution

  • 00650551092797 ()
2105

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-07
In Commercial Distribution

  • 00650551092780 ()

  • Recording Length 0.03125 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-07

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-06
In Commercial Distribution

  • 00650551092773 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.25 Inch
2102-32-06

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-01
In Commercial Distribution

  • 10650551092763 ()
  • 00650551092766 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-01

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
PMT CORPORATION
2102-31-01
In Commercial Distribution

  • 10650551092756 ()
  • 00650551092759 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-31-01

  • Depth electrode
STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-01
In Commercial Distribution

  • 10650551092749 ()
  • 00650551092742 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-32-01

  • Depth electrode
STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
PMT CORPORATION
2101-31-01
In Commercial Distribution

  • 10650551092732 ()
  • 00650551092735 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-31-01

  • 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
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-36-0004
In Commercial Distribution

  • 09348215039905 ()


  • Instrument tray, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-026
In Commercial Distribution

  • 09348215081416 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7050
In Commercial Distribution

  • 09348215087401 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7040
In Commercial Distribution

  • 09348215087395 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7030
In Commercial Distribution

  • 09348215087388 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7020
In Commercial Distribution

  • 09348215087371 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7010
In Commercial Distribution

  • 09348215087364 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7000
In Commercial Distribution

  • 09348215087357 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-409
In Commercial Distribution

  • 09348215058098 ()


  • Instrument tray, reusable
CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube
Device for oocyte collection
LABORATOIRE CCD
HOC COLLECTION VIAL 30ML
In Commercial Distribution

  • 03700111425866 ()
  • 03700111400863 ()

  • Total Volume: 30 Milliliter
1302001

  • Assisted reproduction cryotube
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003033 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
BodyMD Gamma Camera System
Not in Commercial Distribution

  • 05711665003026 ()

  • Width: 291 Centimeter
  • Depth: 197 Centimeter
  • Height: 225 Centimeter
  • Weight: 2144 Kilogram
9PMS3131

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003019 ()

  • Width: 291 Centimeter
  • Depth: 197 Centimeter
  • Height: 225 Centimeter
  • Weight: 2144 Kilogram
9PMS3131

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003002 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
CardioMD Gamma Camera System
Not in Commercial Distribution

  • 05711665002029 ()

  • Width: 284 Centimeter
  • Depth: 150 Centimeter
  • Height: 150 Centimeter
  • Weight: 815 Kilogram
9PMS3060

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
CorCam Gamma Camera System
In Commercial Distribution

  • 05711665002012 ()

  • Width: 284 Centimeter
  • Depth: 150 Centimeter
  • Height: 150 Centimeter
  • Weight: 815 Kilogram
9PMS3060

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
CorCam Gamma Camera System
In Commercial Distribution

  • 05711665002005 ()

  • Weight: 815 Kilogram
  • Height: 150 Centimeter
  • Depth: 150 Centimeter
  • Width: 284 Centimeter
9COR2370

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
c.cam Gamma Camera System
In Commercial Distribution

  • 05711665001008 ()

  • Weight: 1350 Kilogram
  • Height: 169 Centimeter
  • Depth: 229 Centimeter
  • Width: 244 Centimeter
9VIR1200

  • Stationary gamma camera system
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
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
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003146 ()
203511-60

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003139 ()
203511-55

  • Intraurethral valve/pump
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