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, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWZN(AR)(DB1)-00435
In Commercial Distribution

  • 10873263004354 ()
  • 00873263004357 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 249.22 Millimeter
  • Length: 234.22 Millimeter
MTDWZN(AR)(DB1)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWZN(AR)(AR1)-00431
Not in Commercial Distribution

  • 10873263004316 ()
  • 00873263004319 ()

  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Length: 268.5 Millimeter
  • Length: 276.5 Millimeter
MTDWZN(AR)(AR1)

  • Depth electrode
microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z)
FHC, INC.
MTDWZN(AO)(AO9)-00426
In Commercial Distribution

  • 10873263004262 ()
  • 00873263004265 ()

  • Length: 3 Millimeter
  • Outer Diameter: 1.27 Millimeter
  • Impedance: Megaohms
  • Length: 241.86 Millimeter
  • Length: 233.86 Millimeter
MTDWZN(AO)(AO9)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(SP)(JV1)-00411
In Commercial Distribution

  • 10873263004118 ()
  • 00873263004111 ()

  • Length: 276.5 Millimeter
  • Length: 1 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 270.5 Millimeter
MTDWXN(SP)(JV1)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(BS)(OC2)-00409
In Commercial Distribution

  • 10873263004095 ()
  • 00873263004098 ()

  • Length: 2 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 293 Millimeter
  • Length: 286 Millimeter
MTDWXN(BS)(OC2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(BP)(BP7)-00406
In Commercial Distribution

  • 10873263004064 ()
  • 00873263004067 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
MTDWXN(BP)(BP7)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(AR)(AR2)-00404
In Commercial Distribution

  • 10873263004040 ()
  • 00873263004043 ()

  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 261.5 Millimeter
  • Length: 10 Millimeter
MTDWXN(AR)(AR2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BP)(BP8)-00396
In Commercial Distribution

  • 10873263003968 ()
  • 00873263003961 ()

  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Impedance: Megaohms
  • Length: 3 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTDWLN(BP)(BP8)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, D.ZAP(L)
FHC, INC.
MTDWLN(AR)(AR1)-00394
Not in Commercial Distribution

  • 10873263003944 ()
  • 00873263003947 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
  • Length: 276.5 Millimeter
MTDWLN(AR)(AR1)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWCN(AR)(AR2)-00392
In Commercial Distribution

  • 10873263003920 ()
  • 00873263003923 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
MTDWCN(AR)(AR2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(LS)(LS3)-00386
In Commercial Distribution

  • 10873263003869 ()
  • 00873263003862 ()

  • Length: 291.5 Millimeter
  • Length: 273.5 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
MTDWBN(LS)(LS3)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(BP)(BP7)-00384
In Commercial Distribution

  • 10873263003845 ()
  • 00873263003848 ()

  • Length: 256.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
MTDWBN(BP)(BP7)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, non sterile
FHC, INC.
MTDWBN(BP)(BP6)-00382
In Commercial Distribution

  • 10873263003821 ()
  • 00873263003824 ()

  • Length: 227 Millimeter
  • Length: 277 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
MTDWBN(BP)(BP6)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(BP)(BP5)-00380
In Commercial Distribution

  • 10873263003807 ()
  • 00873263003800 ()

  • Length: 215 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 265 Millimeter
  • Outer Diameter: 0.77 Millimeter
MTDWBN(BP)(BP5)

  • Depth electrode
microTargeting Electrode, differential, tungsten, non-sterile
FHC, INC.
MTDWBN(AR)(AR2)-00375
In Commercial Distribution

  • 10873263003753 ()
  • 00873263003756 ()

  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
MTDWBN(AR)(AR2)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(AO)(AO1)-00372
In Commercial Distribution

  • 10873263003722 ()
  • 00873263003725 ()

  • Length: 282 Millimeter
  • Outer Diameter: 1.27 Millimeter
  • Impedance: Megaohms
  • Length: 3 Millimeter
  • Length: 274 Millimeter
MTDWBN(AO)(AO1)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWBN(AO)(A10)-00363
In Commercial Distribution

  • 10873263003630 ()
  • 00873263003633 ()

  • Length: 242 Millimeter
  • Length: 210 Millimeter
  • Outer Diameter: 1.27 Millimeter
  • Length: 27 Millimeter
  • Impedance: Megaohms
MTDWBN(AO)(A10)

  • Depth electrode
microTargeting(TM) Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWAN(AR)(AR1)-00360
Not in Commercial Distribution

  • 10873263003609 ()
  • 00873263003602 ()

  • Impedance: Megaohms
  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
MTDWAN(AR)(AR1)

  • Depth electrode
microTargeting(TM) Electrode, differential, platinum/iridium, glass insulated DZAP(Z), non-sterile
FHC, INC.
MTDPZN(BP)(BP7)-00343
In Commercial Distribution

  • 10873263003432 ()
  • 00873263003435 ()

  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Outer Diameter: 0.86 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
MTDPZN(BP)(BP7)

  • Depth electrode
microTargeting(TM) Electrode, differential, platinum/iridium, glass insulated, specify Z, nonsterile
FHC, INC.
MTDPXN(SP)(AO9)-00335
In Commercial Distribution

  • 10873263003357 ()
  • 00873263003350 ()

  • Length: 1 Millimeter
  • Length: 235.86 Millimeter
  • Length: 241.86 Millimeter
  • Outer Diameter: 1.24 Millimeter
MTDPXN(SP)(AO9)

  • Depth electrode
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660179 ()
30684

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660162 ()
30683

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660155 ()
30682

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660148 ()
30681

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660117 ()
30005

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660100 ()
30004

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660094 ()
30003

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660087 ()
30002

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660070 ()
30001

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660063 ()
30000

  • Treadmill/elliptical gait rehabilitation system
Robotic-assisted gait trainer
Reha Technology AG
G-EO
In Commercial Distribution

  • 07640174420032 ()


  • Treadmill/elliptical gait rehabilitation system
Robotic-assisted gait trainer
Reha Technology AG
G-EO System
In Commercial Distribution

  • 07640174420018 ()


  • Treadmill/elliptical gait rehabilitation system
No Description
CUREXO, Inc.
MW-V100
In Commercial Distribution

  • 08800043810121 ()


  • Treadmill/elliptical gait rehabilitation system
MW-S200
CUREXO, Inc.
MW-S200
In Commercial Distribution

  • 08800043810022 ()
AC-00000-000

  • Treadmill/elliptical gait rehabilitation system
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
sEEG DEPTH ELECTRODE, 4 MACRO CONTACTS, 12.5 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-04-091-NS
In Commercial Distribution

  • 00650551025412 ()


  • Depth electrode
SEEG, PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH, NON-STERILE
PMT CORPORATION
2102-16-185-NS
In Commercial Distribution

  • 00650551002659 ()


  • Depth electrode
SEEG, PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH, NON-STERILE
PMT CORPORATION
2102-16-184-NS
In Commercial Distribution

  • 00650551002642 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 41MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL. NON-STERILE
PMT CORPORATION
2102-16-177-NS
In Commercial Distribution

  • 00650551001140 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 48MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-176-NS
In Commercial Distribution

  • 00650551000860 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 44.5MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-175-NS
In Commercial Distribution

  • 00650551000853 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1.5MM CONTACTS MARCO CONTACT DIA., 8 MACRO CONTACTS, 16 MICROWIRE CONTACTS, 51.1MM RECORDING LENGTH, MINI CONNECTOR, NON-STERILE
PMT CORPORATION
2104-08-16-006-NS
In Commercial Distribution

  • 00650551000471 ()


  • Depth electrode
LiteGait is a Physical Therapy Patient lifting device that allows for body weight support gait therapy.
Mobility Research, Inc.
ALL LiteGait devices
In Commercial Distribution

  • 00850040235012 ()
N/A

  • Gait rehabilitation system harness
The Optimal-G is a robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The Optimal-G enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
A
In Commercial Distribution

  • 07290017844312 ()
OG01-0000-01

  • Gait rehabilitation system harness
The ReoAmbulator model is robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The ReoAmbulator enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
B
In Commercial Distribution

  • 07290017844305 ()
RA01-0000-00

  • Gait rehabilitation system harness
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega MER Headstage
In Commercial Distribution

  • 07290014954991 ()
750-000023-00

  • Depth electrode
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