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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DIASORIN MOLECULAR LLC
MOL2500
In Commercial Distribution

  • 20816101025521 ()


  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
JBAIDS IVD Influenza A Subtyping Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0138
Not in Commercial Distribution

  • 00851458005075 ()
JRPD-ASY-0138

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
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
EKSO BIONICS SYSTEM, Ekso NR
EKSO BIONICS, INC.
EKSONR
In Commercial Distribution

  • B168EKSONR0 ()
EKSONR

  • Programmable ambulation exoskeleton, clinical
EKSO BIONICS SYSTEM, Ekso GT
EKSO BIONICS, INC.
EKSOGT
In Commercial Distribution

  • B168EKSOGT0 ()
EKSOGT

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

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical
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
Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
EKSO BIONICS, INC.
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.
EKSO BIONICS, INC.
501-100-000
In Commercial Distribution

  • M704501100000 ()


  • Programmable ambulation exoskeleton, clinical
Trexo Robotics XL Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321072 ()

  • XL
A001BPX

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Large Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321065 ()

  • Large
A001BPR

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Medium Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321058 ()

  • Medium
A001BPR

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Small Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321041 ()

  • Small
A001BPR

  • Programmable ambulation exoskeleton, clinical
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D30mm
In Commercial Distribution

  • D960BPX00301 ()
30111610

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D28mm
In Commercial Distribution

  • D960BPX00281 ()
30111609

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D25mm
In Commercial Distribution

  • D960BPX00251 ()
30111608

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D24mm
In Commercial Distribution

  • D960BPX00241 ()
30111607

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D22mm
In Commercial Distribution

  • D960BPX00221 ()
30111606

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D20mm
In Commercial Distribution

  • D960BPX00201 ()
30111605

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D18mm
In Commercial Distribution

  • D960BPX00181 ()
30111604

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D16mm
In Commercial Distribution

  • D960BPX00161 ()
30111603

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm
In Commercial Distribution

  • D960BPX00141 ()
30111602

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D12mm
In Commercial Distribution

  • D960BPX00121 ()
30111601

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D10mm
In Commercial Distribution

  • D960BPX00101 ()
30111600

  • Dental appliance fabrication material, ceramic
60" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB60QRNRB
In Commercial Distribution

  • 00840216113978 ()


  • Gait rehabilitation system harness
5 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002446 ()
ADP-05

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

  • 03664539002422 ()
ADP-08

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

  • 03664539002415 ()
ADP-10

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

  • 03664539002408 ()
ADP-12

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

  • 03664539002392 ()
ADP-15

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

  • 03664539002385 ()
ADP-18

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

  • 03664539002279 ()

  • Length: 300 Centimeter
PCP-18A/300

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

  • 03664539002262 ()

  • Length: 90 Centimeter
PCP-18A/90

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

  • 03664539002231 ()

  • Length: 300 Centimeter
PCP-18/300

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

  • 03664539002217 ()

  • Length: 90 Centimeter
PCP-18/90

  • Depth electrode
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
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
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
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
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
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
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
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
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
15 CONTACTS, LENGTH 30CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
Not in Commercial Distribution

  • 03664539001920 ()

  • Length: 30 Centimeter
CBL-15/30

  • Depth electrode
12 CONTACTS, LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001838 ()

  • Length: 300 Centimeter
CBL-12/300

  • Depth electrode
12 CONTACTS, LENGTH 180CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001821 ()

  • Length: 180 Centimeter
CBL-12/180

  • Depth electrode
12 CONTACTS, LENGTH 150CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001814 ()

  • Length: 150 Centimeter
CBL-12/150

  • Depth electrode
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