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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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0901
In Commercial Distribution

  • 09348215051549 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1800
In Commercial Distribution

  • 09348215051532 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1500
In Commercial Distribution

  • 09348215051518 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1400
In Commercial Distribution

  • 09348215051501 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1300
In Commercial Distribution

  • 09348215051495 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1200
In Commercial Distribution

  • 09348215051488 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1100
In Commercial Distribution

  • 09348215051471 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1000
In Commercial Distribution

  • 09348215051464 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0900
In Commercial Distribution

  • 09348215051457 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0800
In Commercial Distribution

  • 09348215051440 ()


  • Coated femoral stem prosthesis, modular
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11668590
In Commercial Distribution

  • 04056869996295 ()


  • General-purpose ultrasound imaging system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10413009
In Commercial Distribution

  • 04056869002729 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08419009
In Commercial Distribution

  • 04056869001272 ()
8419009..

  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910501
In Commercial Distribution

  • 04056869001265 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910500
In Commercial Distribution

  • 04056869001258 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08717741
In Commercial Distribution

  • 04056869001166 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10275879
In Commercial Distribution

  • 04056869001159 ()


  • Stationary gamma camera 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
Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical
The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical
No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228033905 ()
691221

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
DEPTH ELECTRODE, PLATINUM, 2 CONTACT, MINI CONNECTOR
PMT CORPORATION
2102-02-MN-SS
In Commercial Distribution

  • 00650551101949 ()

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

  • Depth electrode
MICROWIRE DEPTH ELECTRODE, 8 MACRO CONTACTS, 24 MICROWIRES, INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS
PMT CORPORATION
2104-08-24-001
In Commercial Distribution

  • 00650551098386 ()

  • Recording Depth 34.5 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 46 Centimeter
  • Contact Size 2 Millimeter
2104-08-24-001

  • Depth electrode
MICROWIRE DEPTH ELECTRODE, 5 MACRO CONTACTS, 20 MICROWIRES, INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS
PMT CORPORATION
2104-05-20-02-IL
In Commercial Distribution

  • 00650551098362 ()

  • Recording Depth 19.5 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 16.5 Centimeter
  • Contact Size 1.5 Millimeter
2104-05-20-02-IL

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-154
In Commercial Distribution

  • 00650551098133 ()

  • Main Tube Length 32 Centimeter
  • Spacing 2.4 Millimeter
  • Recording Depth 110 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-154

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-153
In Commercial Distribution

  • 00650551098126 ()

  • Main Tube Length 32 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 95 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-153

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-152
In Commercial Distribution

  • 00650551098119 ()

  • Main Tube Length 32 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-152

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-151
In Commercial Distribution

  • 00650551098102 ()

  • Main Tube Length 32 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 65 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-151

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-141
In Commercial Distribution

  • 00650551098096 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 100 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-141

  • Depth electrode
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