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

Show Filters

No Description
SHIMADZU CORPORATION
566-16130-82
In Commercial Distribution

  • 04540217071609 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-16130-81
In Commercial Distribution

  • 04540217071593 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-16130-80
In Commercial Distribution

  • 04540217071586 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-65
In Commercial Distribution

  • 04540217071395 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-64
In Commercial Distribution

  • 04540217071388 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-63
In Commercial Distribution

  • 04540217071371 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-62
In Commercial Distribution

  • 04540217071364 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-61
In Commercial Distribution

  • 04540217071357 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-60
In Commercial Distribution

  • 04540217071340 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-54
In Commercial Distribution

  • 04540217071333 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-53
In Commercial Distribution

  • 04540217071326 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-26000-50
In Commercial Distribution

  • 04540217071319 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-12700-75
In Commercial Distribution

  • 04540217062621 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
SHIMADZU CORPORATION
566-12700-65
In Commercial Distribution

  • 04540217062577 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
LIFE TECHNOLOGIES CORPORATION
A32444
In Commercial Distribution

  • 10190302006156 ()


  • PCR/NAT negative control IVD
ONC DX TARGET DNA CONTROL
LIFE TECHNOLOGIES CORPORATION
A32442
In Commercial Distribution

  • 10190302006095 ()


  • Nucleic acid hybridization detection IVD, control
ODXTT UG AND ADF 1.8 - US
LIFE TECHNOLOGIES CORPORATION
A32461
In Commercial Distribution

  • 10190302006071 ()


  • Human genomic analysis interpretive software
No Description
LIFE TECHNOLOGIES CORPORATION
A32443
In Commercial Distribution

  • 10190302006064 ()


  • Nucleic acid hybridization detection IVD, control
No Description
LIFE TECHNOLOGIES CORPORATION
A29362
In Commercial Distribution

  • 10190302005852 ()


  • Nucleic acid hybridization detection IVD, control
No Description
LIFE TECHNOLOGIES CORPORATION
A29361
In Commercial Distribution

  • 10190302005845 ()


  • Nucleic acid hybridization detection IVD, control
No Description
LIFE TECHNOLOGIES CORPORATION
A30320
In Commercial Distribution

  • 10190302000888 ()


  • PCR/NAT negative control IVD
No Description
Resolution Bioscience, Inc.
500029
Not in Commercial Distribution

  • 00850059806005 ()


  • Venous blood collection kit IVD
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000051 ()
MXU-RV71

  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000044 ()
MXU-RV60

  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000037 ()
MXU-RV35

  • Mobile basic diagnostic x-ray system, digital
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 09357123000013 ()
MXU-RV19

  • Mobile basic diagnostic x-ray system, digital
MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI) tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the approved therapeutic product labeling. Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed as companion diagnostic indications are not prescriptive or conclusive for labeled use of any specific therapeutic product.
CARIS MPI, INC.
MCS000
In Commercial Distribution

  • 00860008613325 ()


  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
MasteRad MX-30 Radiographic System
Medicatech Usa, Inc.
MasteRad MX30
In Commercial Distribution

  • 00860001404753 ()
MasteRad MX30

  • Stationary basic diagnostic x-ray system, digital
oncoReveal CDx - Kit (Boxes 1 through 4)
Pillar Biosciences, Inc.
HDA-LC-2001-48
In Commercial Distribution

  • 00860001218282 ()
HDA-LC-2001-4

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution

  • 00860001218275 ()
SFW-2012

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
oncoReveal CDx Box 4 of 4. This box contains extra white and orange caps for reagents.
Pillar Biosciences, Inc.
HDA-LC-2001-48-4
In Commercial Distribution

  • 00860001218251 ()
HDA-LC-2001-48-4

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
oncoReveal CDx Box 3 of 4. This box contains Purification Beads.
Pillar Biosciences, Inc.
HDA-LC-2001-48-3
In Commercial Distribution

  • 00860001218244 ()
HDA-LC-2001-48-3

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
oncoReveal CDx Box 2 of 4. This box contains all of the indexing primers and indexing PCR master mix.
Pillar Biosciences, Inc.
HDA-LC-2001-48-2
In Commercial Distribution

  • 00860001218237 ()
HDA-LC-2001-48-2

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
oncoReveal CDx Box 1 of 4. This box contains the Oligo Pool, Gene Specific Master Mix, Uracil-DNA Glycosylase (UDG), and Positive Control.
Pillar Biosciences, Inc.
HDA-LC-2001-48-1
In Commercial Distribution

  • 00860001218220 ()
HDA-LC-2001-48-1

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost
Not in Commercial Distribution

  • 00884838064751 ()
712214

  • Stationary basic diagnostic x-ray system, digital
The DuraDiagnost Compact is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost Compact
Not in Commercial Distribution

  • 00884838064737 ()
712213

  • Stationary basic diagnostic x-ray system, digital
SYRINGE LABELER
BECTON, DICKINSON AND COMPANY
516800
In Commercial Distribution

  • 00382905168000 ()
516800

  • Intravenous injection automated detection/documentation system processor/transmitter
SKANMOBILE DR is a digital radiographic system designed for superior image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator.
SKANRAY TECHNOLOGIES LIMITED
303-000018-16
In Commercial Distribution

  • 08904269403683 ()


  • Mobile basic diagnostic x-ray system, digital
SCHICK33 S0 SENSOR RMA KIT, 9FT
Dentsply International Inc.
B1318052
In Commercial Distribution

  • D003B13180520 ()
B1318052

  • Dental digital imaging sensor, intraoral
SCHICK33 S0 SENSOR RMA KIT, 6FT
Dentsply International Inc.
B1318051
In Commercial Distribution

  • D003B13180510 ()
B1318051

  • Dental digital imaging sensor, intraoral
< 1 ... 144 145 146 147 148 ... 220 >