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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ELI 380 upgrade to enable use with the WAM Wireless Acquisition Module. Upgrade includes WAM Wireless Acquisition Module, 12 lead IEC lead set, set of 10 adapter clips.
WELCH ALLYN, INC.
901095
In Commercial Distribution

  • 00732094261349 ()
UPG380-B-WAM-B

  • Electrocardiograph, professional, multichannel
A standalone HeRO monitor for two infants
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000234 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware
A HeRO System for the private room
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000227 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware
No Description
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000210 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware
Server based HeRO System
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000203 ()


  • Neonatal/paediatric heart rate monitoring hardware
  • Neonatal/paediatric heart rate monitoring application software
Magphan® 172, Complete Magphan® including 20cm spherical housing, 20cm cylindrical housing, 10cm test cube and cases.
Providus Holdings, Inc.
SMR172
In Commercial Distribution

  • 00812266030925 ()
SMR172

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
Magphan® 140, 10cm sphere with support disk.
Providus Holdings, Inc.
SMR140
In Commercial Distribution

  • 00812266030901 ()
SMR140

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
Magphan® 100, Complete Magphan® including 20cm spherical housing, 10cm test cube and case.
Providus Holdings, Inc.
SMR100
In Commercial Distribution

  • 00812266030895 ()
SMR100

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
Magphan® 170, Complete Magphan® including 20cm cylindrical housing, 10cm test cube and case.
Providus Holdings, Inc.
SMR170
In Commercial Distribution

  • 00812266030918 ()
SMR170

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
LiquiPhil™ End-to-End Pelvis, includes pelvis form, two 10cm ovoid tumor vessels and permanent storage case
Providus Holdings, Inc.
TLP260
In Commercial Distribution

  • 00812266030772 ()
TLP260

  • MRI phantom, test object
  • Multi-modality therapeutic radiation phantom, test object
The device is an optical impression system. It is used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.
CEFLA SOCIETA' COOPERATIVA
NewTom IOS
In Commercial Distribution

  • 08033837932970 ()
70960000

  • Intraoral optical scanning system
  • Dental milling system, CAD/CAM, chairside
Norav Receiver for wireless PC-ECG Acquisition Device Norav 1200W with ECG Trigger Output.
Norav Medical GmbH
1200WR
In Commercial Distribution

  • 04260498566907 ()
1200WR-D-00-09

  • Electrocardiographic signal amplifier
Safety Deluxe bone Marrow Biopsy/Aspiration Tray with Snare-it marrow acquisition & Aspiration needle
ROBERT BUSSE & CO., INC.
988
Not in Commercial Distribution

  • 10849233013831 ()
  • 00849233013834 ()
988

  • Bone marrow biopsy procedure kit
J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula 11g x4"
ROBERT BUSSE & CO., INC.
628
In Commercial Distribution

  • 00849233013179 ()
  • 10849233013176 ()
628

  • Bone marrow biopsy needle, single-use
Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru2301CF)
VATECH CO., LTD.
VistaPano
Not in Commercial Distribution

  • 08800016401868 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PHT-35LHS
In Commercial Distribution

  • 08800016401318 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT/CEPH Image Acquisition Xmaru1404CF-Plus, Xmaru2602CF
VATECH CO., LTD.
PHT-30CSS
In Commercial Distribution

  • 08800016401103 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1404CF/W-Pano_R1/MASTER)
VATECH CO., LTD.
PHT-30LFO
Not in Commercial Distribution

  • 08800016400618 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1314CF/G2/MASTER)
VATECH CO., LTD.
PHT-65LHS
In Commercial Distribution

  • 08800016400595 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF-PLUS / Xmaru2602CF)
VATECH CO., LTD.
VistaPano S Ceph
In Commercial Distribution

  • 08800016401967 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PHT-65LHS
In Commercial Distribution

  • 08800016400410 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PHT-65LHS
Not in Commercial Distribution

  • 08800016400397 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PHT-35LHS
Not in Commercial Distribution

  • 08800016400373 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru2301CF)
VATECH CO., LTD.
ProVecta S-Pan
In Commercial Distribution

  • 08800016400311 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Digital X-ray Imaging System functioning Pano/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / 910SGA)
VATECH CO., LTD.
PCH-2500
Not in Commercial Distribution

  • 08800016400298 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Digital X-ray Imaging System functioning Pano/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / 1210SGA)
VATECH CO., LTD.
PCH-2500
Not in Commercial Distribution

  • 08800016400281 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru2301CF)
VATECH CO., LTD.
PCH-2500
In Commercial Distribution

  • 08800016400274 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1524CF(H))
VATECH CO., LTD.
PHT-60CFO
In Commercial Distribution

  • 08800016400113 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
Dental Computed Tomography X-ray System functioning Pano/CT Image Acquisition (Xmaru1501CF / Xmaru1524CF(V))
VATECH CO., LTD.
PHT-60CFO
Not in Commercial Distribution

  • 08800016400076 ()


  • Stationary panoramic/tomographic dental x-ray system, digital
JAMSHIDI (TJ) BONE MARROW BIOPSY/ASPIRATION NEEDLE WITH MARROW ACQUISITION CRADLE 11G X6
CAREFUSION 2200, INC
TJM6011
In Commercial Distribution

  • 50885403044609 ()
  • 10885403044601 ()

  • Length: 6 Inch
  • Needle Gauge: 11 Gauge
TJM6011

  • Bone marrow biopsy needle, single-use
JAMSHIDI (TJ) BONE MARROW BIOPSY/ASPIRATION NEEDLE WITH MARROW ACQUISITION CRADLE 11G X4
CAREFUSION 2200, INC
TJM4011
In Commercial Distribution

  • 50885403044586 ()
  • 10885403044588 ()

  • Length: 4 Inch
  • Needle Gauge: 11 Gauge
TJM4011

  • Bone marrow biopsy needle, single-use
JAMSHIDI (TJ) BONE MARROW BIOPSY/ASPIRATION NEEDLE WITH MARROW ACQUISITION CRADLE 13G X3.5
CAREFUSION 2200, INC
TJM3513
In Commercial Distribution

  • 50885403044548 ()
  • 10885403044540 ()

  • Needle Gauge: 13 Gauge
  • Length: 3.5 Inch
TJM3513

  • Bone marrow biopsy needle, single-use
PC-ECG Wireless Acquisition Device (Rev.01) for Stress-Test ECG with IEC type labelling
NORAV MEDICAL LTD.
1200W1
In Commercial Distribution

  • 07290110253752 ()
1200W1-D-00E-01

  • Electrocardiography telemetric monitoring system transmitter
PC-ECG Wireless Acquisition Device (Rev.01) for Stress-Test ECG with AHA type labelling
NORAV MEDICAL LTD.
1200W1
In Commercial Distribution

  • 07290110253769 ()
1200W1-D-00U-01

  • Electrocardiography telemetric monitoring system transmitter
Drill bit D4.5 L300 conical
WITTENSTEIN intens GmbH
DRBI D4.5 L300 CO
Not in Commercial Distribution

  • 04260170140692 ()
60001605

  • Orthopaedic bur, reusable
Remanufactured Stat Profile pHOx Ultra CO-Oximeter Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA CO OX
In Commercial Distribution

  • 10385480420171 ()
  • 00385480420174 ()
42017

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Stat Profile pHOx Ultra Co-Oximeter Analyzer
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA CO OX
In Commercial Distribution

  • 10385480420133 ()
  • 00385480420136 ()
42013

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Magnetic stimulation coil
Tonica Elektronik A/S
Coil Cool B-70 CO
In Commercial Distribution

  • 05713484020468 ()
9016E0181

  • Magnetic neural stimulation system
Sunglasses (non-prescriptionincluding photosensitive)
Etnia Barcelona, Llc.
5 GORGON 51S CO
In Commercial Distribution

  • 18435736022818 ()
  • 08435736022811 ()


  • Tinted non-prescription spectacles
Frame Spectacle
Etnia Barcelona, Llc.
5 GORGON 51D CO
In Commercial Distribution

  • 18435736022801 ()
  • 08435736022804 ()


  • Spectacle frame
Sunglasses (non-prescriptionincluding photosensitive)
Etnia Barcelona, Llc.
5 AVINY3 51S CO
In Commercial Distribution

  • 18435736007006 ()
  • 08435736007009 ()


  • Tinted non-prescription spectacles
Frame Spectacle
Etnia Barcelona, Llc.
5 AVINY3 51D CO
In Commercial Distribution

  • 18435736006993 ()
  • 08435736006996 ()


  • Spectacle frame
Frame Spectacle
Etnia Barcelona, Llc.
5 BRUT31 47O CO
In Commercial Distribution

  • 18435736061992 ()
  • 08435736061995 ()


  • Spectacle frame
Frame Spectacle
Etnia Barcelona, Llc.
6 NERI 49O CO
In Commercial Distribution

  • 18435685008604 ()
  • 08435685008607 ()


  • Spectacle frame
Frame Spectacle
Etnia Barcelona, Llc.
6 FLUX 53O CO
In Commercial Distribution

  • 18435685006600 ()
  • 08435685006603 ()


  • Spectacle frame
Frame Spectacle
Etnia Barcelona, Llc.
6 AURA 55O CO
In Commercial Distribution

  • 18435685004569 ()
  • 08435685004562 ()


  • Spectacle frame
Frame Spectacle
Etnia Barcelona, Llc.
6 FLUX 51O CO
In Commercial Distribution

  • 18435685006280 ()
  • 08435685006283 ()


  • Spectacle frame
sunglasses (non-prescriptionincluding photosensitive)
Etnia Barcelona, Llc.
5 EPIC 52S CO
In Commercial Distribution

  • 18435736076224 ()
  • 08435736076227 ()


  • Tinted non-prescription spectacles
Frame Spectacle
Etnia Barcelona, Llc.
5 EPIC 52D CO
In Commercial Distribution

  • 18435736076217 ()
  • 08435736076210 ()


  • Spectacle frame
HANDLE AXIAL MONO with monopolar HF connection, for use with all insulated ERAGON outer sheath tubes, reusable
Richard Wolf GmbH
83930084
In Commercial Distribution

  • 04055207026656 ()
83930084

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
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