Company Name Brand Name GMDN Term 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
112-212-110
In Commercial Distribution

  • 09348215074739 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-109
In Commercial Distribution

  • 09348215074722 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-108
In Commercial Distribution

  • 09348215074715 ()


  • Surgical implant template, reusable
Queen's Square Bladder Stimulator (PC9)
MALEM MEDICAL LIMITED
PC9
In Commercial Distribution

  • 05060049630199 ()


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

  • 05060049630144 ()


  • Bladder-emptying vibratory stimulator
Digital Transmitter for the Avery Breathing Pacemaker System
Avery Biomedical Devices Inc
NeurostimulatorTransmitter Digital
In Commercial Distribution

  • 00850252006066 ()
Spirit

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Avery Biomedical Devices Inc
Transtelephonic Monitor
In Commercial Distribution

  • 00850252006059 ()
TTM

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
(902A) 2.0 m Lead Length
Avery Biomedical Devices Inc
External Antenna
In Commercial Distribution

  • 00850252006042 ()
902AL

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
(902A) 1.0 m Lead Length
Avery Biomedical Devices Inc
External Antenna
In Commercial Distribution

  • 00850252006035 ()
902A

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Avery Biomedical Devices Inc
Neurostimulator Transmitter
In Commercial Distribution

  • 00850252006004 ()
MARK IV

  • Extramuscular diaphragm/phrenic nerve electrical stimulation 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
The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
EKSO BIONICS, INC.
GT
In Commercial Distribution

  • B1431200000 ()


  • Programmable ambulation exoskeleton, clinical
Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
PARKER-HANNIFIN CORPORATION
501-110-001
In Commercial Distribution

  • M704501110001 ()


  • Programmable ambulation exoskeleton, clinical
Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
PARKER-HANNIFIN CORPORATION
501-100-000
In Commercial Distribution

  • M704501100000 ()


  • Programmable ambulation exoskeleton, clinical
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter.
Flowonix Medical, Inc.
11827
In Commercial Distribution

  • 00810335020082 ()


  • Implantable intrathecal infusion pump, programmable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroProbe
In Commercial Distribution

  • 17290014954974 ()
  • 07290014954977 ()
STR-94685Z-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroProbe
In Commercial Distribution

  • 17290014954967 ()
  • 07290014954960 ()
STR-94685L-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroProbe
In Commercial Distribution

  • 17290014954950 ()
  • 07290014954953 ()
STR-000664-21

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroProbe
In Commercial Distribution

  • 17290014954943 ()
  • 07290014954946 ()
STR-AP9080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 17290014954875 ()
  • 07290014954878 ()
STR-050925-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-Shielded
In Commercial Distribution

  • 17290014954868 ()
  • 07290014954861 ()
STR-000136-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954847 ()
  • 17290014954844 ()
STR-001080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954830 ()
  • 17290014954837 ()
STR-000081-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290014954625 ()
  • 17290014954622 ()
STR-901079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290014954618 ()
  • 17290014954615 ()
STR-901024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290014954601 ()
  • 17290014954608 ()
STR-009024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290014954595 ()
  • 17290014954592 ()
STR-009079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290014954588 ()
  • 17290014954585 ()
STR-090244-00

  • Depth electrode
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