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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No Description
OXOID LIMITED
MB1561A
In Commercial Distribution

  • 05032384128006 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1133A
In Commercial Distribution

  • 05032384127979 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1132A
In Commercial Distribution

  • 05032384127962 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1131A
In Commercial Distribution

  • 05032384127955 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1082A
In Commercial Distribution

  • 05032384127917 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1128A
In Commercial Distribution

  • 05032384127498 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
The VITEK® 2 GN Identification Card is intended for use with the VITEK 2 to determine ID of clinically important Gram negative bacteria
BIOMERIEUX , INC.
VITEK® 2 GN
In Commercial Distribution

  • 03573026131913 ()
  • 03573026529987 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
VITEK® 2 GP Identification Card is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms
BIOMERIEUX , INC.
VITEK® 2 GP
In Commercial Distribution

  • 03573026131920 ()
  • 03573026529994 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
Kit Crystal Rapid Gram-Positive Id
BECTON, DICKINSON AND COMPANY
245250
Not in Commercial Distribution

  • 30382902452509 ()
  • 00382902452508 ()
245250

  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
BD BBL™ Crystal™ GP Gram-Positive ID System
BECTON, DICKINSON AND COMPANY
245240
Not in Commercial Distribution

  • 30382902452400 ()
  • 00382902452409 ()
245240

  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
BD BBL™ Crystal™ Enteric/ID Inoculum Fluid
BECTON, DICKINSON AND COMPANY
245029
Not in Commercial Distribution

  • 30382902450291 ()
  • 00382902450290 ()
245029

  • Multiple gram negative bacteria species culture isolate identification IVD, kit
BD BBL™ Crystal™ E/NF
BECTON, DICKINSON AND COMPANY
245000
Not in Commercial Distribution

  • 30382902450000 ()
  • 00382902450009 ()
245000

  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Neg ID Panel Type 2
Beckman Coulter, Inc.
B1017-27
In Commercial Distribution

  • 15099590657604 ()
  • 05099590657607 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Pos ID Panel Type 3
Beckman Coulter, Inc.
B1017-221
In Commercial Distribution

  • 15099590657581 ()
  • 05099590657584 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
MicroScan Rapid Pos ID Panel Type 2
Beckman Coulter, Inc.
B1017-166
In Commercial Distribution

  • 15099590657338 ()
  • 05099590657331 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
MicroScan Rapid Neg ID Panel Type 4
Beckman Coulter, Inc.
B1017-165
In Commercial Distribution

  • 15099590657321 ()
  • 05099590657324 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Rapid Neg ID Panel Type 3
Beckman Coulter, Inc.
B1017-110
In Commercial Distribution

  • 15099590657239 ()
  • 05099590657232 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan 10% Ferric Chloride - 250ml
Beckman Coulter, Inc.
B1015-48
In Commercial Distribution

  • 15099590655884 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan 0.5% N, N-Dimethylalphanaphthylamine - 250mL
Beckman Coulter, Inc.
B1015-45
In Commercial Distribution

  • 15099590655860 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan 0.8% Sulfanilic Acid - 250ml
Beckman Coulter, Inc.
B1015-44
In Commercial Distribution

  • 15099590655853 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan 40% Potassium Hydroxide - 250ml
Beckman Coulter, Inc.
B1015-43
In Commercial Distribution

  • 15099590655846 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan Kovac's Reagent - 250ml
Beckman Coulter, Inc.
B1015-41
In Commercial Distribution

  • 15099590655822 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Peptidase - 250ml
Beckman Coulter, Inc.
B1015-30
In Commercial Distribution

  • 15099590655808 ()


  • Multiple Candida/yeast species culture isolate identification IVD, kit
MicroScan Rapid Indole Reagent-F
Beckman Coulter, Inc.
B1015-17
In Commercial Distribution

  • 15099590655709 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan HNID Indole Reagent - 30ml
Beckman Coulter, Inc.
B1015-15
In Commercial Distribution

  • 15099590655686 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Peptidase - 30ml
Beckman Coulter, Inc.
B1012-30B
In Commercial Distribution

  • 15099590655495 ()


  • Multiple Candida/yeast species culture isolate identification IVD, kit
MicroScan 10% Ferric Chloride - 30ml
Beckman Coulter, Inc.
B1010-48A
In Commercial Distribution

  • 15099590655259 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan 0.5% N, N-Dimethylalphanaphthylamine - 30mL
Beckman Coulter, Inc.
B1010-45A
In Commercial Distribution

  • 15099590655242 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan 0.8% Sulflanilic Acid - 30ml
Beckman Coulter, Inc.
B1010-44A
In Commercial Distribution

  • 15099590655235 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan 40% Potassium Hydroxide - 30ml
Beckman Coulter, Inc.
B1010-43A
In Commercial Distribution

  • 15099590655228 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan Kovac's Reagent - 30ml
Beckman Coulter, Inc.
B1010-41A
In Commercial Distribution

  • 15099590655204 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Alpha Naphthol - 1.5g
Beckman Coulter, Inc.
B1010-42A
In Commercial Distribution

  • 15099590655211 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan Mineral Oil - 250ml
Beckman Coulter, Inc.
B1010-40A
In Commercial Distribution

  • 15099590655198 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan Mineral Oil - 60ml
Beckman Coulter, Inc.
B1010-40
In Commercial Distribution

  • 15099590655181 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
BD Phoenix™ PID
BECTON, DICKINSON AND COMPANY
448008
In Commercial Distribution

  • 00382904480080 ()
  • 30382904480081 ()
448008

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
BD Phoenix™ NID
BECTON, DICKINSON AND COMPANY
448007
In Commercial Distribution

  • 00382904480073 ()
  • 30382904480074 ()
448007

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
ORTHO Ficin Panel System RESOLVE PANEL C Ficin Treated and Untreated 22X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
719410
In Commercial Distribution

  • 10758750003976 ()
719410

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1828
Not in Commercial Distribution

  • 04953170291470 ()
N3626130

  • Touchscreen
No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
OMST1065
In Commercial Distribution

  • 00889024596078 ()

  • Width: 65.00 Inch
OMST1065

  • Touchscreen
No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
OMST1050
In Commercial Distribution

  • 00889024596061 ()

  • Width: 50.00 Inch
OMST1050

  • Touchscreen
AM Systems SCC Touchscreen Monitor
ABBOTT MOLECULAR INC.
02J11-056
In Commercial Distribution

  • 00884999048843 ()
02J11-056

  • Touchscreen
Stent System
BOSTON SCIENTIFIC CORPORATION
M00574660
In Commercial Distribution

  • 08714729820550 ()

  • 10 mm Diameter
  • 40 mm Length


  • Ophthalmic cryosurgical system control unit
MAJ-1868 ScopeGuide Receiver Dish
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1868
In Commercial Distribution

  • 04953170305689 ()


  • Gastrointestinal catheter/endoscope tracking system sensor, bedside
4 mode full body panel
Biophotas, Inc.
Series 2 DELUX C/US
In Commercial Distribution

  • 00850523007891 ()
CDL2-001

  • Blue/red/infrared phototherapy lamp
3 mode full body panel
Biophotas, Inc.
DELUX XL C/US
In Commercial Distribution

  • 00850523007143 ()
CDLX-003

  • Blue/red/infrared phototherapy lamp
3 mode full body panel
Biophotas, Inc.
DELUX C/US
In Commercial Distribution

  • 00850523007129 ()
CDLX-001

  • Blue/red/infrared phototherapy lamp
4 mode full body panel
Biophotas, Inc.
Series 2 DELUX XL C/US
In Commercial Distribution

  • 00850523007938 ()
CXL2-001

  • Blue/red/infrared phototherapy lamp
ABL80 FLEX Full panel, Analyzer
Radiometer Medical ApS
393-839
Not in Commercial Distribution

  • 05700693938394 ()
393-839

  • Metabolic profile clinical chemistry analyser IVD
Radiation Shielding Panel, portal/mobile
Rampart Ic, LLC
M1128-RTV01
In Commercial Distribution

  • 00860002090108 ()


  • Radiation shielding panel, portable/mobile
KIT, DOOR PANEL - BASIC - BLK
NORTH AMERICAN RESCUE, LLC
80-1166
In Commercial Distribution

  • 00842209119141 ()
80-1166

  • First aid kit, medicated
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