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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NxSTEP Unweighing System
BIODEX MEDICAL SYSTEMS, INC.
945-480
In Commercial Distribution

  • 00718175004807 ()
945-480

  • Mobile gait rehabilitation system, harness-support
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
The ZeroG-Lite system is intended to assist patients with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Lite should never be used to lift and transport patients, and should never be connected to inanimate objects. ZeroG-Lite should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG-Lite training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGL-V3
In Commercial Distribution

  • 00850018836234 ()


  • Gait rehabilitation frame, electric
The ZeroG-Passive System is intended to assist subjects with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Passive should never be connected to inanimate objects. ZeroG-Passive should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use.
ARETECH, LLC
ZGP-110
In Commercial Distribution

  • 00850018836067 ()


  • Gait rehabilitation frame, manual
The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer. The Ovation 700 model allows for a patient weight capacity of up to 700 pounds with a dynamic body-weight support range of 25 to 300 pounds.
ARETECH, LLC
OV-700
In Commercial Distribution

  • 00850018836043 ()


  • Gait rehabilitation frame, electric
The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer. The Ovation 400 model allows for a patient weight capacity of up to 400 pounds with a dynamic body-weight support range of 10 to 200 pounds.
ARETECH, LLC
OV-400
In Commercial Distribution

  • 00850018836029 ()


  • Gait rehabilitation frame, electric
The ZeroG Gait & Balance System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG can also be used to train subjects ambulating on a treadmill. ZeroG should never be used to lift and transport subjects, and should never be connected to inanimate objects. ZeroG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGGB-V3
In Commercial Distribution

  • 00850018836012 ()


  • Gait rehabilitation frame, electric
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-02
In Commercial Distribution

  • 00850005539025 ()


  • Neuro-controlled joint movement exoskeleton
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-01
In Commercial Distribution

  • 00850005539018 ()


  • Neuro-controlled joint movement exoskeleton
Gait Trainer
RIFTON EQUIPMENT
K620
In Commercial Distribution

  • 00850001752244 ()


  • Gait rehabilitation frame, manual
Gait Trainer
RIFTON EQUIPMENT
K610
In Commercial Distribution

  • 00850001752237 ()


  • Gait rehabilitation frame, manual
Luminaire is a robotic body-weight support system fixed above a slat-belt treadmill. The system provides precise levels of dynamic body-weight support to the patient as they walk on the treadmill, while simultaneously preventing falls. Clinician seating and footplates can be used for situations where manual-assisted ambulation is desired. The Luminaire System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice ambulating on a treadmill. Luminaire should never be used to lift subjects and should never be connected to inanimate objects. Luminaire should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the Luminaire training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
LU-001
In Commercial Distribution

  • 00850018836272 ()


  • Gait rehabilitation frame, electric
ZeroG 3D is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The ZeroG 3D System is intended to assist subjects who have experienced neurological and orthopedic injures as they practice therapeutic activities related to walking and balance activities. ZeroG 3D can also be used to train subjects ambulating on a treadmill. ZeroG 3D should never be used to lift and transport subjects and should never be connected to inanimate objects. ZeroG 3D should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG 3D training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZG3D-001
In Commercial Distribution

  • 00850018836265 ()


  • Gait rehabilitation frame, electric
The BabyG Early Mobilization System is a robotic body-weight support system which automatically tracks patients as they move freely in any direction. The dynamic body-weight support offloads a percentage of the patient’s weight as they perform activities in a full 3-dimensional workspace, while the advanced fall protection provides the highest level of safety. The BabyG System is intended to assist subjects weighing 50 pounds or less as they practice therapeutic activities related to walking and balance activities. BabyG should never be used to lift and transport subjects and should never be connected to inanimate objects. BabyG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the BabyG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
BG-001
In Commercial Distribution

  • 00850018836258 ()


  • Gait rehabilitation frame, electric
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
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 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 ES GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AB
In Commercial Distribution

  • 00195278421579 ()
5875815-20

  • 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 GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912AA
In Commercial Distribution

  • 00195278421586 ()
5875815-10

  • Stationary gamma camera system
Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
SENTINELLA 102 HORUS
In Commercial Distribution

  • 08437018413027 ()

  • Height: 185 Centimeter
  • Depth: 77 Centimeter
  • Width: 63 Centimeter
  • Weight: 134 Kilogram
FP-0055

  • Mobile gamma camera system
Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
SENTINELLA 102
In Commercial Distribution

  • 08437018413010 ()

  • Height: 185 Centimeter
  • Depth: 77 Centimeter
  • Width: 63 Centimeter
  • Weight: 134 Kilogram
FP-0040

  • Mobile gamma camera system
GammaPro Straight Standard Probe for wireless ionizing radiation detection.
Kubtec
K0018C01
In Commercial Distribution

  • B619GPROSTDPROBE0 ()


  • Mobile gamma camera system
GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0018C02
In Commercial Distribution

  • B619GPROSTDKIT0 ()


  • Mobile gamma camera system
GammaPro Angled Standard Probe used for wireless ionizing radiation detection.
Kubtec
K0021C01
In Commercial Distribution

  • B619GPROSTDANGPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.
Kubtec
K0020C01
In Commercial Distribution

  • B619GPROLAPPROBE0 ()


  • Mobile gamma camera system
GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0020C02
In Commercial Distribution

  • B619GPROLAPKIT0 ()


  • Mobile gamma camera system
GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
Kubtec
K0019C01
In Commercial Distribution

  • B619GPROHISPROBE0 ()


  • Mobile gamma camera system
GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0019C02
In Commercial Distribution

  • B619GPROHISKIT0 ()


  • Mobile gamma camera system
Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.
Kubtec
K0017C01
In Commercial Distribution

  • B619GPROCASETABL2 ()


  • Mobile gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
SoloMobile Gamma Camera System
In Commercial Distribution

  • 05711665004009 ()

  • Weight: 252 Kilogram
  • Height: 173 Centimeter
  • Depth: 138 Centimeter
  • Width: 70 Centimeter
9SOL2210

  • Mobile gamma camera system
Stat Profile pHOx Ultra/CCX Control CO-Ox Tri Level L7, 8 ,9 (amps)
NOVA BIOMEDICAL CORPORATION
phox ultra/ccx
In Commercial Distribution

  • 00385480491877 ()
  • 00385489491878 ()
49187

  • Assisted reproduction centrifuge tube
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