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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BD MAX™ Vaginal Panel
BECTON, DICKINSON AND COMPANY
443712
In Commercial Distribution

  • 00382904437121 ()
443712

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
EMG USB Control Panel II
NATUS NEUROLOGY INCORPORATED
043281
In Commercial Distribution

  • 00382830063272 ()


  • Electromyograph
Endeavor CR Mini Control Panel
NATUS NEUROLOGY INCORPORATED
515-013400
In Commercial Distribution

  • 00382830041621 ()


  • Electromyograph
Negative Control for T2Bacteria Panel
T2 BIOSYSTEMS, INC.
85-08074
In Commercial Distribution

  • M70885080743 ()
  • M70883080760 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control
PANEL,MESH,REPLACEMENT FOR 13672,1
MEDLINE INDUSTRIES, INC.
MDT013672RM
In Commercial Distribution

  • 10888277417717 ()
MDT013672RM

  • Patient surgical drape, reusable
Alere Triage® Cardiac Panel
ALERE SAN DIEGO, INC.
97000HSEU
Not in Commercial Distribution

  • 00899722002719 ()
97000HSEU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Remote MRI needle connection panel
GALIL MEDICAL LTD
FPRCH2030
Not in Commercial Distribution

  • 07290104830884 ()
FPRCH2030

  • General cryosurgical system, cryogen gas, electronic
Triage Profiler SOB Panel (OUS)
QUIDEL CARDIOVASCULAR INC.
97300EU
In Commercial Distribution

  • 30014613337959 ()
97300EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardiac Panel (CK/TnI)
QUIDEL CARDIOVASCULAR INC.
97022HS
In Commercial Distribution

  • 30014613337942 ()
97022HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
DOA Panel cutoff +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008419
In Commercial Distribution

  • 00810042684164 ()
18008419

  • Multiple drugs of abuse IVD, control
DOA Panel cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008418
In Commercial Distribution

  • 00810042684157 ()
18008418

  • Multiple drugs of abuse IVD, control
16 Panel 3X cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18001425
In Commercial Distribution

  • 00810042683990 ()
18001425

  • Multiple drugs of abuse IVD, control
16 Panel cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18001424
In Commercial Distribution

  • 00810042683983 ()
18001424

  • Multiple drugs of abuse IVD, control
16 Panel cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18001423
In Commercial Distribution

  • 00810042683976 ()
18001423

  • Multiple drugs of abuse IVD, control
22 Panel High Positive 2x5mL
BIOCHEMICAL DIAGNOSTICS INC
PQ-22H-01
In Commercial Distribution

  • 00810042683969 ()
PQU-22H-01

  • Multiple drugs of abuse IVD, control
22 Panel Low Positive 2x5mL
BIOCHEMICAL DIAGNOSTICS INC
PQ-22-01
In Commercial Distribution

  • 00810042683952 ()
PQ-22U-01

  • Multiple drugs of abuse IVD, control
Drug Evaluation Panel, #1-20, 3mL
BIOCHEMICAL DIAGNOSTICS INC
26657
In Commercial Distribution

  • 00810042680913 ()
26657

  • Multiple drugs of abuse IVD, control
11 PANEL, 2X Cutoff 20mL
BIOCHEMICAL DIAGNOSTICS INC
18007713
In Commercial Distribution

  • 00810042680654 ()
18007713

  • Multiple drugs of abuse IVD, control
9 PANEL, 2X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18007710
In Commercial Distribution

  • 00810042680647 ()
18007710

  • Multiple drugs of abuse IVD, control
CP-UR Panel, Cutoff +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18007525
In Commercial Distribution

  • 00810042680562 ()
18007525

  • Multiple drugs of abuse IVD, control
FRONT PANEL DRAPES, STERILE/10
Bausch & Lomb Incorporated
DP5300
In Commercial Distribution

  • 20757770055276 ()
  • 00757770055272 ()
DP5300

  • General surgical procedure kit, non-medicated, single-use
DRX-LC Digital Flat Panel Detector
iRay Group
DRX-LC
In Commercial Distribution

  • 06970569090504 ()


  • Indirect flat panel x-ray detector
Venu1748V-WF Digital Flat Panel Detector
iRay Group
Venu1748V
In Commercial Distribution

  • 06970569090498 ()


  • Indirect flat panel x-ray detector
Mercu1717V Digital Flat Panel Detector
iRay Group
Mercu1717V
In Commercial Distribution

  • 06970569090450 ()


  • Indirect flat panel x-ray detector
Venu1748V Digital Flat Panel Detector
iRay Group
Venu1748V
In Commercial Distribution

  • 06970569090399 ()


  • Indirect flat panel x-ray detector
DR17T Digital Flat Panel Detector_LTF
iRay Group
DR17T
In Commercial Distribution

  • 06970569090306 ()


  • Indirect flat panel x-ray detector
Panel Phoenix Nmic Id 303
BECTON, DICKINSON AND COMPANY
448744
Not in Commercial Distribution

  • 30382904487448 ()
  • 00382904487447 ()
448744

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix Nmic Id 304
BECTON, DICKINSON AND COMPANY
448743
Not in Commercial Distribution

  • 30382904487431 ()
  • 00382904487430 ()
448743

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix Pmic/Id 109
BECTON, DICKINSON AND COMPANY
448609
Not in Commercial Distribution

  • 30382904486090 ()
  • 00382904486099 ()
448609

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix Pmic/Id 108
BECTON, DICKINSON AND COMPANY
448608
Not in Commercial Distribution

  • 30382904486083 ()
  • 00382904486082 ()
448608

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
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