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
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.
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
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 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
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
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-027
In Commercial Distribution

  • 09348215081423 ()


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

  • 09348215055783 ()


  • Surgical implant template, reusable
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11668590
In Commercial Distribution

  • 04056869996295 ()


  • General-purpose ultrasound imaging system
Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Smoke Evacuator,100-120 V, 50/60 Hz; 10 Amps
Covidien LP
SE3690
In Commercial Distribution

  • 10884524001555 ()


  • Surgical plume evacuation system
Smoke Evacuator 110V
Covidien LP
SE3690ZD
In Commercial Distribution

  • 10884521134140 ()


  • Surgical plume evacuation system
Smoke Evacuator,220-240 V, 50/60 Hz; 8 Amps
Covidien LP
SE3695
In Commercial Distribution

  • 10884524001753 ()


  • Surgical plume evacuation system
Smoke evacuation system 220V for Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters required and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
ELVV220
In Commercial Distribution

  • 10841736114992 ()


  • Surgical plume evacuation system
Smoke Evacuation System for Models Ergon 2 and 3, includes pneumatic foot switch. Requires H8-300-41-A mounting bracket. AIR SAFE filters and QUIKLINK automatic activation device sold separately.
SKYTRON LLC
SMOKE-E-VAC
In Commercial Distribution

  • 10841736100810 ()
SMOKE-E-VAC

  • Surgical plume evacuation system
Automatic activation device for Smoke-e-vac
SKYTRON LLC
QUIKLINK
In Commercial Distribution

  • 10841736100773 ()
QUIKLINK

  • Surgical plume evacuation system
ULPA/CHARCOAL FILTER CATRIDGES
Conmed Corporation
60-5902-001
Not in Commercial Distribution

  • 20848584045456 ()
  • 10848584045459 ()
  • 00848584045452 ()
60-5902-001

  • Surgical plume evacuation system
MiniVac Smoke Evacuation System 220-240V 50/60 Hz
Conmed Corporation
ECVV220
Not in Commercial Distribution

ECVV220

  • Surgical plume evacuation system
MiniVac Smoke Evacuation System 100V-120V 50/60 Hz
Conmed Corporation
ECVV120
In Commercial Distribution

  • 10614559104422 ()
  • 10845854053096 ()
  • 30845854053090 ()
ECVV120

  • Surgical plume evacuation system
Smoke Shark III Smoke Evacuator 100V-120V 50/60Hz
Conmed Corporation
SE03-120
In Commercial Distribution

  • 20845854600099 ()
  • 10845854600092 ()
SE03-120

  • Surgical plume evacuation system
Smoke Shark III Smoke Evacuator 220V-240V 50/60Hz
Conmed Corporation
SE03-220
In Commercial Distribution

  • 20845854600082 ()
  • 10845854600085 ()
SE03-220

  • Surgical plume evacuation system
No Description
NORTHGATE TECHNOLOGIES INC.
7-700-00
In Commercial Distribution

  • 00817183020684 ()


  • Surgical plume evacuation system
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