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
HOCOMA AG
V2.0
In Commercial Distribution

  • 07640174660230 ()
31585

  • Mobile gait rehabilitation system, harness-support
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003010 ()
403507

  • Intraurethral valve/pump
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003001 ()
403507

  • Intraurethral valve/pump
Vector Gait and Safety System, Base Model
BIONESS INC.
VEC-3000
In Commercial Distribution

  • 00815962020283 ()


  • Gait rehabilitation frame, manual
Vector Trolley Assembly, Elite Model
BIONESS INC.
VEC-1100
In Commercial Distribution

  • 00815962020276 ()


  • Gait rehabilitation frame, electric
Vector Gait and Safety System
BIONESS INC.
VEC-1000
In Commercial Distribution

  • 00815962020269 ()


  • Gait rehabilitation frame, electric
830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00195278788252 ()
5376204-33

  • Stationary gamma camera system
MyoSPECT ES to MyoSPECT Upgrade kit
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BS
In Commercial Distribution

  • 00195278722546 ()
5941445

  • Stationary gamma camera system
MyoSPECT ES MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BD
In Commercial Distribution

  • 00195278488626 ()
5875815-40

  • Stationary gamma camera system
MyoSPECT MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BC
In Commercial Distribution

  • 00195278488619 ()
5875815-30

  • Stationary gamma camera system
MyoSPECT GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AA
In Commercial Distribution

  • 00195278421586 ()
5875815-10

  • Stationary gamma camera system
MyoSPECT ES GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AB
In Commercial Distribution

  • 00195278421579 ()
5875815-20

  • Stationary gamma camera system
Number of legs: Double Leg length: eXtra long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DXWUS
In Commercial Distribution

  • 04560340091091 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Long Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DLWUS
In Commercial Distribution

  • 04560340091084 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Medium Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DMWUS
In Commercial Distribution

  • 04560340091077 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Short Hip width: Wide
CYBERDYNE, INC.
HAL-ML05-DSWUS
In Commercial Distribution

  • 04560340091060 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: eXtra long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DXMUS
In Commercial Distribution

  • 04560340090971 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Long Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DLMUS
In Commercial Distribution

  • 04560340090964 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Medium Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DMMUS
In Commercial Distribution

  • 04560340090957 ()


  • Neuro-controlled ambulation exoskeleton
Number of legs: Double Leg length: Short Hip width: Medium
CYBERDYNE, INC.
HAL-ML05-DSMUS
In Commercial Distribution

  • 04560340090940 ()


  • Neuro-controlled ambulation exoskeleton
The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
PICOLA-SCINTRON
In Commercial Distribution

  • 04260484140074 ()


  • Stationary gamma camera system
The MIE - Gamma Camera Systems for nuclear medicine is used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients.
MiE medical imaging electronics GmbH
SYNGULA-SCINTRON
In Commercial Distribution

  • 04260484140043 ()


  • Stationary gamma camera system
The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnostic nuclear medicine used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients. The ECAM SCINTRON Gamma Camera System is substantially equivalent to the legally market device e.cam, K963983, from Siemens and our device SCINTRON, K101 01 3. The changes incorporated into the remanufactured ECAM Gamma Camera include economical and ecological issues. This closes the gap between more durable electronics and mechanics lifetimes and shortened development cycles.
MiE medical imaging electronics GmbH
ECAM-SCINTRON
In Commercial Distribution

  • 04260484140036 ()


  • Stationary gamma camera system
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-027
In Commercial Distribution

  • 09348215081423 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-170
In Commercial Distribution

  • 09348215055974 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-168
In Commercial Distribution

  • 09348215055967 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-166
In Commercial Distribution

  • 09348215055950 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-165
In Commercial Distribution

  • 09348215055943 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-164
In Commercial Distribution

  • 09348215055936 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-163
In Commercial Distribution

  • 09348215055929 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-162
In Commercial Distribution

  • 09348215055912 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-161
In Commercial Distribution

  • 09348215055905 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-160
In Commercial Distribution

  • 09348215055899 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-159
In Commercial Distribution

  • 09348215055882 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-158
In Commercial Distribution

  • 09348215055875 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-024
In Commercial Distribution

  • 09348215055790 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-023
In Commercial Distribution

  • 09348215055783 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
101-139
In Commercial Distribution

  • 09348215055356 ()


  • Orthopaedic broach
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11668590
In Commercial Distribution

  • 04056869996295 ()


  • General-purpose ultrasound imaging system
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi 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 OM2
In Commercial Distribution

  • D960BPMM2141 ()
30112199

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi 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 C2
In Commercial Distribution

  • D960BPMC2141 ()
30112210

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi 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 C1
In Commercial Distribution

  • D960BPMC1141 ()
30112209

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi 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 B4
In Commercial Distribution

  • D960BPMB4141 ()
30112208

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi 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 B3
In Commercial Distribution

  • D960BPMB3141 ()
30112207

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi 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 B2
In Commercial Distribution

  • D960BPMB2141 ()
30112206

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi 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 B1
In Commercial Distribution

  • D960BPMB1141 ()
30112205

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi 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 A3.5
In Commercial Distribution

  • D960BPMA5141 ()
30112203

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi 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 A4
In Commercial Distribution

  • D960BPMA4141 ()
30112204

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi 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 A3
In Commercial Distribution

  • D960BPMA3141 ()
30112202

  • Dental appliance fabrication material, ceramic
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi 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 A2
In Commercial Distribution

  • D960BPMA2141 ()
30112201

  • Dental appliance fabrication material, ceramic
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