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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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Avery Breathing Pacemaker System - 00850252006004

No Description
Avery Biomedical Devices Inc
Neurostimulator Transmitter
In Commercial Distribution

  • 00850252006004 ()
MARK IV

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Malem - 05060049630199

Queen's Square Bladder Stimulator (PC9)
MALEM MEDICAL LIMITED
PC9
In Commercial Distribution

  • 05060049630199 ()


  • Bladder-emptying vibratory stimulator

Malem - 05060049630144

Queen's Square Bladder Stimulator - Selectable (PC9S)
MALEM MEDICAL LIMITED
PC9S
In Commercial Distribution

  • 05060049630144 ()


  • Bladder-emptying vibratory stimulator

Origin Size 18 Template - 09348215074807

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-118
In Commercial Distribution

  • 09348215074807 ()


  • Surgical implant template, reusable

Origin Size 16 Template - 09348215074791

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-116
In Commercial Distribution

  • 09348215074791 ()


  • Surgical implant template, reusable

Origin Size 14 Template - 09348215074777

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-114
In Commercial Distribution

  • 09348215074777 ()


  • Surgical implant template, reusable

Origin Size 13 Template - 09348215074760

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-113
In Commercial Distribution

  • 09348215074760 ()


  • Surgical implant template, reusable

Origin Size 12 Template - 09348215074753

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-112
In Commercial Distribution

  • 09348215074753 ()


  • Surgical implant template, reusable

Origin Size 11 Template - 09348215074746

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-111
In Commercial Distribution

  • 09348215074746 ()


  • Surgical implant template, reusable

Origin Size 10 Template - 09348215074739

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-110
In Commercial Distribution

  • 09348215074739 ()


  • Surgical implant template, reusable

Origin Size 9 Template - 09348215074722

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-109
In Commercial Distribution

  • 09348215074722 ()


  • Surgical implant template, reusable

Origin Size 8 Template - 09348215074715

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-108
In Commercial Distribution

  • 09348215074715 ()


  • Surgical implant template, reusable

Origin Size 15 Template - 09348215074784

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-115
In Commercial Distribution

  • 09348215074784 ()


  • Surgical implant template, reusable

Atalante X - 03665965000129

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

KEEOGO - CLINICIAN KIT - 07540162060007

Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical

ReWalk(TM) Rehabilitaiton - 00861803000327

Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical

ReStore - 00860001744507

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

Trexo Robotics - 00628719321072

Trexo Robotics XL Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321072 ()

  • XL
A001BPX

  • Programmable ambulation exoskeleton, clinical

Trexo Robotics - 00628719321065

Trexo Robotics Large Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321065 ()

  • Large
A001BPR

  • Programmable ambulation exoskeleton, clinical

Trexo Robotics - 00628719321058

Trexo Robotics Medium Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321058 ()

  • Medium
A001BPR

  • Programmable ambulation exoskeleton, clinical

Trexo Robotics - 00628719321041

Trexo Robotics Small Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321041 ()

  • Small
A001BPR

  • Programmable ambulation exoskeleton, clinical

NA - 03664539002446

5 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002446 ()
ADP-05

  • Depth electrode

NA - 03664539002422

8 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002422 ()
ADP-08

  • Depth electrode

NA - 03664539002415

10 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002415 ()
ADP-10

  • Depth electrode

NA - 03664539002408

12 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002408 ()
ADP-12

  • Depth electrode

NA - 03664539002392

15 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002392 ()
ADP-15

  • Depth electrode

NA - 03664539002385

18 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002385 ()
ADP-18

  • Depth electrode

NA - 03664539002279

LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
Not in Commercial Distribution

  • 03664539002279 ()

  • Length: 300 Centimeter
PCP-18A/300

  • Depth electrode

NA - 03664539002262

LENGTH 90CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
Not in Commercial Distribution

  • 03664539002262 ()

  • Length: 90 Centimeter
PCP-18A/90

  • Depth electrode

NA - 03664539002231

LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
In Commercial Distribution

  • 03664539002231 ()

  • Length: 300 Centimeter
PCP-18/300

  • Depth electrode

NA - 03664539002217

LENGTH 90CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
In Commercial Distribution

  • 03664539002217 ()

  • Length: 90 Centimeter
PCP-18/90

  • Depth electrode

NA - 03664539002187

18 CONTACTS, LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539002187 ()

  • Length: 300 Centimeter
CBL-18/300

  • Depth electrode

NA - 03664539002170

18 CONTACTS, LENGTH 180CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539002170 ()

  • Length: 180 Centimeter
CBL-18/180

  • Depth electrode

NA - 03664539002163

18 CONTACTS, LENGTH 150CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539002163 ()

  • Length: 150 Centimeter
CBL-18/150

  • Depth electrode

NA - 03664539002156

18 CONTACTS, LENGTH 120CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539002156 ()

  • Length: 120 Centimeter
CBL-18/120

  • Depth electrode

NA - 03664539002118

18 CONTACTS, LENGTH 30CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
Not in Commercial Distribution

  • 03664539002118 ()

  • Length: 30 Centimeter
CBL-18/30

  • Depth electrode

NA - 03664539001999

15 CONTACTS, LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001999 ()

  • Length: 300 Centimeter
CBL-15/300

  • Depth electrode

NA - 03664539001982

15 CONTACTS, LENGTH 180CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001982 ()

  • Length: 180 Centimeter
CBL-15/180

  • Depth electrode

NA - 03664539001975

15 CONTACTS, LENGTH 150CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001975 ()

  • Length: 150 Centimeter
CBL-15/150

  • Depth electrode

NA - 03664539001968

15 CONTACTS, LENGTH 120CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001968 ()

  • Length: 120 Centimeter
CBL-15/120

  • Depth electrode
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