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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CADIERE FORCEPS
INTUITIVE SURGICAL, INC.
478055
In Commercial Distribution

  • 00886874113608 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical forceps, reusable
SUCTION IRRIGATOR
INTUITIVE SURGICAL, INC.
478054
In Commercial Distribution

  • 00886874113592 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical irrigation/aspiration cannula, reusable
CLIP APPLIER, MEDIUM-LARGE
INTUITIVE SURGICAL, INC.
478053
In Commercial Distribution

  • 00886874113585 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical ligation clip applier
MARYLAND DISSECTOR
INTUITIVE SURGICAL, INC.
478050
In Commercial Distribution

  • 00886874113561 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical scissors, endoscopic
ACCESSORY OBTRUATOR
INTUITIVE SURGICAL, INC.
478013
In Commercial Distribution

  • 00886874113554 ()

  • Outer Diameter: 5 Millimeter


  • Rigid endoscope obturator
BLUNT OBTRUATOR
INTUITIVE SURGICAL, INC.
478008
In Commercial Distribution

  • 00886874113547 ()

  • Outer Diameter: 8 Millimeter


  • Rigid endoscope obturator
DOCK ASSIST TOOL
INTUITIVE SURGICAL, INC.
428083
In Commercial Distribution

  • 00886874113479 ()


  • Surgical instrument assist arm system, manually-adjusted
CANNULA SEAL
INTUITIVE SURGICAL, INC.
478161
In Commercial Distribution

  • 30886874112725 ()
  • 10886874112721 ()
  • 00886874112724 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 5 Millimeter


  • Laparoscopic access cannula seal, single-use
STAPLER BLADELESS OBTURATOR, LONG
INTUITIVE SURGICAL, INC.
470396
In Commercial Distribution

  • 00886874112649 ()

  • Outer Diameter: 12 Millimeter


  • Laparoscopic trocar blade, reusable
STAPLER BLADELESS OBTURATOR
INTUITIVE SURGICAL, INC.
470395
In Commercial Distribution

  • 00886874112632 ()

  • Outer Diameter: 12 Millimeter


  • Laparoscopic trocar blade, reusable
CURVED NEEDLE DRIVER
INTUITIVE SURGICAL, INC.
428088
In Commercial Distribution

  • 00886874112083 ()

  • Outer Diameter: 8 Millimeter


  • Robotic surgical needle holder, reusable
BLUNT LATCHING OBTURATOR
INTUITIVE SURGICAL, INC.
428084
In Commercial Distribution

  • 00886874112076 ()

  • Outer Diameter: 10 Millimeter


  • Rigid endoscope obturator
BIPOLAR MARYLAND
INTUITIVE SURGICAL, INC.
428080
In Commercial Distribution

  • 10886874112066 ()
  • 00886874112069 ()

  • Outer Diameter: 5 Millimeter


  • Robotic electrosurgical instrument, bipolar, single-use
ACCESSORY CANNULA
INTUITIVE SURGICAL, INC.
428076
In Commercial Distribution

  • 00886874112052 ()

  • Lumen/Inner Diameter: 10 Millimeter


  • Laparoscopic access cannula, reusable
FLEXIBLE BLUNT OBTRUATOR
INTUITIVE SURGICAL, INC.
428074
In Commercial Distribution

  • 00886874112045 ()

  • Length: 250 Millimeter
  • Outer Diameter: 5 Millimeter


  • Rigid endoscope obturator
CURVED CANNULA ARM2
INTUITIVE SURGICAL, INC.
428072
In Commercial Distribution

  • 00886874112038 ()

  • Length: 250 Millimeter
  • Lumen/Inner Diameter: 5 Millimeter


  • Laparoscopic access cannula, reusable
CURVED CANNULA ARM1
INTUITIVE SURGICAL, INC.
428071
In Commercial Distribution

  • 00886874112021 ()

  • Length: 250 Millimeter
  • Lumen/Inner Diameter: 5 Millimeter


  • Laparoscopic access cannula, reusable
FLEXIBLE BLUNT OBTRUATOR
INTUITIVE SURGICAL, INC.
428064
In Commercial Distribution

  • 00886874112007 ()

  • Outer Diameter: 5 Millimeter


  • Rigid endoscope obturator
CURVED CANNULA ARM2
INTUITIVE SURGICAL, INC.
428062
In Commercial Distribution

  • 00886874111994 ()

  • Length: 250 Millimeter
  • Lumen/Inner Diameter: 5 Millimeter


  • Laparoscopic access cannula, reusable
CURVED CANNULA ARM1
INTUITIVE SURGICAL, INC.
428061
In Commercial Distribution

  • 00886874111987 ()

  • Lumen/Inner Diameter: 5 Millimeter
  • Length: 250 Millimeter


  • Laparoscopic access cannula, reusable
ACCESSORY CANNULA
INTUITIVE SURGICAL, INC.
428060
In Commercial Distribution

  • 00886874111970 ()

  • Lumen/Inner Diameter: 5 Millimeter


  • Laparoscopic access cannula, reusable
CROCODILE GRASPER
INTUITIVE SURGICAL, INC.
428059
In Commercial Distribution

  • 00886874111963 ()

  • Outer Diameter: 5 Millimeter


  • Flexible endoscopic tissue manipulation forceps, reusable
FUNDUS GRASPER
INTUITIVE SURGICAL, INC.
428058
In Commercial Distribution

  • 00886874111956 ()

  • Outer Diameter: 5 Millimeter


  • Flexible endoscopic tissue manipulation forceps, reusable
CURVED SCISSORS
INTUITIVE SURGICAL, INC.
428057
In Commercial Distribution

  • 00886874111949 ()

  • Outer Diameter: 5 Millimeter


  • Flexible endoscopic scissors, reusable
CADIERE FORCEPS
INTUITIVE SURGICAL, INC.
428055
In Commercial Distribution

  • 00886874111925 ()

  • Outer Diameter: 5 Millimeter


  • Flexible endoscopic tissue manipulation forceps, reusable
SUCTION IRRIGATOR
INTUITIVE SURGICAL, INC.
428054
In Commercial Distribution

  • 00886874111918 ()

  • Outer Diameter: 5 Millimeter


  • Surgical irrigation/aspiration handpiece, reusable
CLIP APPLIER, HEM-O-LOK ML
INTUITIVE SURGICAL, INC.
428053
In Commercial Distribution

  • 00886874111901 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical ligation clip applier
MONOPOLAR CAUTERY
INTUITIVE SURGICAL, INC.
428052
In Commercial Distribution

  • 00886874111895 ()

  • Outer Diameter: 5 Millimeter


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
MARYLAND DISSECTOR
INTUITIVE SURGICAL, INC.
428050
In Commercial Distribution

  • 00886874111888 ()

  • Outer Diameter: 5 Millimeter


  • Flexible endoscopic scissors, reusable
ENDOSCOPE
INTUITIVE SURGICAL, INC.
311465
In Commercial Distribution

  • 00886874110010 ()

  • Outer Diameter: 12 Millimeter
  • Angle: 30 degree


  • Rigid optical laparoscope
ENDOSCOPE
INTUITIVE SURGICAL, INC.
311464
In Commercial Distribution

  • 00886874110003 ()

  • Outer Diameter: 12 Millimeter
  • Angle: 0 degree


  • Rigid optical laparoscope
ENDOSCOPE PORT
INTUITIVE SURGICAL, INC.
428065
In Commercial Distribution

  • 30886874112015 ()
  • 10886874112011 ()
  • 00886874112014 ()

  • Lumen/Inner Diameter: 8.5 Millimeter


  • Laparoscopic multi-instrument access port, single-use
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE17
In Commercial Distribution

  • B201CGCORE170 ()
  • B201CGCORE171 ()
CG-CORE17

  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
No Description
medimaps group SA
3
In Commercial Distribution

  • B214OSPTM3 ()


  • Bone densitometry ultrasound phantom, test object
  • Bone densitometry x-ray phantom, test object
  • Diagnostic ultrasound phantom, test object
  • CT phantom, test object
  • General-purpose diagnostic x-ray phantom, test object
  • Multi-modality diagnostic imaging phantom, test object
Norav 1200 Series PC-ECG Software Kit for COSMED with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I1 = Restin-ECG Measurement The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1
In Commercial Distribution

  • 07290110252793 ()
HASP-SW-K-S2I1-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer
The BOND Controller provides the computer that contains the software (version 6.0/W10 IoT) that controls the processing Module(s).
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND Controller (6.0/W10 loT)
In Commercial Distribution

  • 09349458004859 ()
S21.4621

  • Microscope slide stainer IVD
Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows computer running ShuntCheck software to the ShuntCheck Thermosensor
NEURODX DEVELOPMENT LLC
DAQ-1
In Commercial Distribution

  • 00865435000328 ()
DAQ-1

  • Heater/cooler system tester kit
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
8-Channel
In Commercial Distribution

  • EBCI5120PRO0 ()

  • Channel Number 8
5120PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel-rX
In Commercial Distribution

  • EBCI5112PRO0 ()

  • Channel Number 16
5112PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel-mB
In Commercial Distribution

  • EBCI5111PRO0 ()

  • Channel Number 16
5111PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel
In Commercial Distribution

  • EBCI5110PRO0 ()

  • Channel Number 16
5110PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32-Channel-CSP
In Commercial Distribution

  • EBCI5101PRO0 ()

  • Channel Number 32
5101PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32-Channel
In Commercial Distribution

  • EBCI5100PRO0 ()

  • Channel Number 32
5100PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
19 FLEXIBLE channels
In Commercial Distribution

  • EBCI5730PRO0 ()
5730PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
8 FLEXIBLE channels
In Commercial Distribution

  • EBCI5720PRO0 ()
5720PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16 FLEXIBLE channels
In Commercial Distribution

  • EBCI5710PRO0 ()
5710PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
32 FLEXIBLE channels
In Commercial Distribution

  • EBCI5700PRO0 ()
5700PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
8-Channel Sahara
In Commercial Distribution

  • EBCI5220PRO0 ()

  • Channel Number 8
5220PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel-rX Sahara
In Commercial Distribution

  • EBCI5212PRO0 ()

  • Channel Number 16
5212PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16-Channel-mB Sahara
In Commercial Distribution

  • EBCI5211PRO0 ()

  • Channel Number 16
5211PRO

  • Multiple physiological signal amplifier
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