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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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NATUS NEUROLOGY INCORPORATED - 00382830029322

RESPONSE UNIT ASSY, SYNERGY
NATUS NEUROLOGY INCORPORATED
031C006
In Commercial Distribution

  • 00382830029322 ()


  • Electromyograph

NATUS NEUROLOGY - 00382830029001

PATIENT INTERFACE UNIT
NATUS NEUROLOGY INCORPORATED
S035K020
In Commercial Distribution

  • 00382830029001 ()


  • Electromyograph

NATUS NEUROLOGY - 00382830028998

PATIENT INTERFACE UNIT-FIXED
NATUS NEUROLOGY INCORPORATED
S035K020F
In Commercial Distribution

  • 00382830028998 ()


  • Electromyograph

NATUS NEUROLOGY - 00382830028691

SAMPLE ELC/NCS BAR ELEC
NATUS NEUROLOGY INCORPORATED
S-N6003
In Commercial Distribution

  • 00382830028691 ()


  • Electromyograph

Natus - 00382830020923

P32-STIM POD 2 (A-D)-20' (CR)
XLTEK
002512
In Commercial Distribution

  • 00382830020923 ()


  • Electromyograph

Natus - 00382830020916

P32-STIM POD 1 (E-H)-20' (CR)
XLTEK
002511
In Commercial Distribution

  • 00382830020916 ()


  • Electromyograph

Natus - 00382830020909

P32-STIM POD 1 (A-D)-20' (CR)
XLTEK
002510
In Commercial Distribution

  • 00382830020909 ()


  • Electromyograph

Natus - 00382830020886

P32 ACQ POD 3 - 20'
XLTEK
002500
In Commercial Distribution

  • 00382830020886 ()


  • Electromyograph

Natus - 00382830020862

P32 ACQ Pod 1 - 20'
XLTEK
002498
In Commercial Distribution

  • 00382830020862 ()


  • Electromyograph

Natus - 00382830020855

P32-STIM POD 2 (E-H)-10' (CR)
XLTEK
002509
In Commercial Distribution

  • 00382830020855 ()


  • Electromyograph

Natus - 00382830020848

P32 - STIM POD 2 (A-D) - 10'
XLTEK
002508
In Commercial Distribution

  • 00382830020848 ()


  • Electromyograph

Natus - 00382830020831

P32-STIM POD 1 (E-H)-10' (CR)
XLTEK
002507
In Commercial Distribution

  • 00382830020831 ()


  • Electromyograph

Natus - 00382830020824

P32-STIM POD 1 (A-D)-10' (CR)
NATUS NEUROLOGY INCORPORATED
002506
In Commercial Distribution

  • 00382830020824 ()


  • Electromyograph

Natus - 00382830020817

P32 ACQ POD 4 - 10' (CR)
XLTEK
002497
In Commercial Distribution

  • 00382830020817 ()


  • Electromyograph

Natus - 00382830020787

P32 ACQ POD 1 - 10'
XLTEK
002494
In Commercial Distribution

  • 00382830020787 ()


  • Electromyograph

Natus - 00382830020770

P32 - TCMEP Pod (Cr)
XLTEK
002514
In Commercial Distribution

  • 00382830020770 ()


  • Electromyograph

Natus - 00382830020763

Probe Pod - P32 (Cr)
XLTEK
003708
In Commercial Distribution

  • 00382830020763 ()


  • Electromyograph

Natus - 00382830020756

P32-STIM POD 2 (E-H)-20' (CR)
XLTEK
002513
In Commercial Distribution

  • 00382830020756 ()


  • Electromyograph

Natus - 00382830019101

NATUS PHOTIC STIM KIT, NO INTERFACE CABLE
XLTEK
003555-JP
In Commercial Distribution

  • 00382830019101 ()


  • Electromyograph

NATUS NEUROLOGY - 00382830019095

SYNERGY N PORTABLE 5 CH W/EP
NATUS NEUROLOGY INCORPORATED
N5EP-MU
In Commercial Distribution

  • 00382830019095 ()


  • Electromyograph

Natus - 00382830016094

AUDITORY STIMULATION HEADPHONES FOR XLTEK NEUROMAX
XLTEK
102610
In Commercial Distribution

  • 00382830016094 ()


  • Electromyograph

Natus - 00382830015967

P32 Pulse Oxi LP Cable
XLTEK
010384
In Commercial Distribution

  • 00382830015967 ()


  • Electromyograph

Natus - 00382830015950

Nonin LP Trex cable
XLTEK
010382
In Commercial Distribution

  • 00382830015950 ()


  • Electromyograph

Natus - 00382830015790

Natus Photic Stim Kit
XLTEK
003555
In Commercial Distribution

  • 00382830015790 ()


  • Electromyograph

Natus - 00382830011259

Protektor 32 Auditory Stim H/phone
XLTEK
005032
In Commercial Distribution

  • 00382830011259 ()


  • Electromyograph

Natus - 00382830011013

Protektor 32 Ear Inserts
XLTEK
005562
In Commercial Distribution

  • 00382830011013 ()


  • Electromyograph

Natus - 00382830011006

Protektor 32 Pulse Oximeter Cable
XLTEK
005033
In Commercial Distribution

  • 00382830011006 ()


  • Electromyograph

Natus - 00382830010986

Protektor 32 Cautery Detector
XLTEK
005030
In Commercial Distribution

  • 00382830010986 ()


  • Electromyograph

Natus - 00382830010979

Protektor 32 Acquisition Box
XLTEK
002980
In Commercial Distribution

  • 00382830010979 ()


  • Electromyograph

Natus - 00382830010962

Protektor 32 Stimulation Box
XLTEK
002979
In Commercial Distribution

  • 00382830010962 ()


  • Electromyograph

Natus - 00382830010955

Protektor 32 - Isolation Box
XLTEK
002978
In Commercial Distribution

  • 00382830010955 ()


  • Electromyograph

NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System - 00850015518294

Controller. The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator
ANX ROBOTICA CORP
Controller/ NaviEC-2000
In Commercial Distribution

  • 00850015518294 ()
MC-US-1002

  • Video capsule endoscopy system capsule magnetic manipulation unit

NaviCam Capsule Endoscope System - 00850015518201

Controller. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule to be controlled by an operator.
ANX ROBOTICA CORP
Controller/NaviEC-1000
In Commercial Distribution

  • 00850015518201 ()
MC-US-1001

  • Video capsule endoscopy system capsule magnetic manipulation unit

Alpine BioMed - 00613994242297

KEYPOINT WS UKXP-OS
Alpine Biomed ApS
9031A006501
Not in Commercial Distribution

  • 00613994242297 ()


  • Electromyograph

ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENT - 04953170360824

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2039
Not in Commercial Distribution

  • 04953170360824 ()
N5368940

  • Video capsule endoscopy system application software

ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENT - 04953170360817

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2038
Not in Commercial Distribution

  • 04953170360817 ()
N5368840

  • Video capsule endoscopy system application software

ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE - 04953170373848

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2190
In Commercial Distribution

  • 14953170373845 ()
  • 04953170373848 ()
N5400540

  • Video capsule endoscopy system application software

ENDOCAPSULE SOFTWARE 10 LIGHT - 04953170373800

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2189
In Commercial Distribution

  • 14953170373807 ()
  • 04953170373800 ()
N5400440

  • Video capsule endoscopy system application software

ENDOCAPSULE SOFTWARE 10 - 04953170373763

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2188
In Commercial Distribution

  • 14953170373760 ()
  • 04953170373763 ()
N5400340

  • Video capsule endoscopy system application software

N/A - 04961333241903

BULB, HALOGEN
PENTAX OF AMERICA, INC.
2140-0031
In Commercial Distribution

  • 04961333241903 ()


  • Laryngostroboscope system

Focus - 04650075330074

2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms.
NEUROSOFT, OOO
Focus
In Commercial Distribution

  • 04650075330074 ()


  • Electromyograph

Sun Nuclear Tissue Mimicking Phantom - B136411LE0

No Description
SUN NUCLEAR CORP.
TMM
In Commercial Distribution

  • B136411LE0 ()


  • Diagnostic ultrasound phantom, test object

Sun Nuclear Sono403 Multi-Purpose Phantom SCG - B136403GSLE0

No Description
SUN NUCLEAR CORP.
403GSLE
In Commercial Distribution

  • B136403GSLE0 ()


  • Diagnostic ultrasound phantom, test object

TMJOINT - B179TMJ

BTS TMJOINT is a wireless surface electromyograph to measure the differential influence of the occlusal function through indices validated and published in scientific literature
BTS SPA
1.0
In Commercial Distribution

  • B179TMJ1 ()
  • B179TMJ ()
BTSEMB1BM

  • Electromyograph

TEETHAN - B179THN2

Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system To measure relative (intra-patient) levels of activity of 2 muscles during a functional act
BTS SPA
2.0
In Commercial Distribution

  • B179THN1 ()
  • B179THN2 ()
BTSEMB1BM

  • Electromyograph

OMNIsEMG - B179OMN

BTS OMNIsEMG is an instrument for the electromyographic surface analysis.
BTS SPA
1.0
In Commercial Distribution

  • B179OMN ()
BTSEMB1BM

  • Electromyograph

FREEEMG - B179FR1

BTS FREEEMG 1000 is a wireless surface electromyograph for the acquisition and transmission of EMG signals and for the assessment of angles, angular velocities, angular accelerations and foot-floor contact areas. It allows the functional evaluation and a real-time visualization of the acquired signals for biofeedback and monitoring applications.
BTS SPA
1000
In Commercial Distribution

  • B179FR11 ()
  • B179FR1 ()
BTSEMB1BM

  • Electromyograph

FREEEMG - B179FE3

BTS FREEEMG 300 is a wireless surface electromyograph, which makes the selection of muscles, the setting of duration and frequency of acquisition, amplification gain and the correct positioning of electrodes, simple and rapid.
BTS SPA
300
In Commercial Distribution

  • B179FE31 ()
  • B179FE3 ()
BTSFE3

  • Electromyograph

Eckert & Ziegler Isotope Products, Inc. - 00810117211141

Attenuation Correction Point Source
Eckert & Ziegler Isotope Products, Inc.
A3015
In Commercial Distribution

  • 00810117211141 ()


  • Nuclear medicine phantom, point source

Eckert & Ziegler Isotope Products, Inc. - 00810117211134

Attenuation Correction Point Source
Eckert & Ziegler Isotope Products, Inc.
35-2-1
In Commercial Distribution

  • 00810117211134 ()


  • Nuclear medicine phantom, point source
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