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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Pos Combo Panel Type 44
Beckman Coulter, Inc.
B1017-218
In Commercial Distribution

  • 15099590657574 ()
  • 05099590657577 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos Combo Panel Type 43
Beckman Coulter, Inc.
B1017-217
In Commercial Distribution

  • 15099590657567 ()
  • 05099590657560 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos MIC Panel Type 34
Beckman Coulter, Inc.
B1017-216
In Commercial Distribution

  • 15099590657550 ()
  • 05099590657553 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos Combo Panel Type 34
Beckman Coulter, Inc.
B1017-214
In Commercial Distribution

  • 15099590657543 ()
  • 05099590657546 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos MIC Panel Type 29
Beckman Coulter, Inc.
B1017-212
In Commercial Distribution

  • 15099590657536 ()
  • 05099590657539 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos Combo Panel Type 33
Beckman Coulter, Inc.
B1017-211
In Commercial Distribution

  • 15099590657529 ()
  • 05099590657522 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos MIC Panel Type 26
Beckman Coulter, Inc.
B1017-210
In Commercial Distribution

  • 15099590657512 ()
  • 05099590657515 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos Combo Panel Type 29
Beckman Coulter, Inc.
B1017-209
In Commercial Distribution

  • 15099590657499 ()
  • 05099590657492 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos Combo Panel Type 21
Beckman Coulter, Inc.
B1017-201
In Commercial Distribution

  • 15099590657383 ()
  • 05099590657386 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Pos Combo Panel Type 20
Beckman Coulter, Inc.
B1017-200
In Commercial Distribution

  • 15099590657376 ()
  • 05099590657379 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
MicroScan Rapid Anaerobe ID Panel
Beckman Coulter, Inc.
B1017-2
In Commercial Distribution

  • 15099590657352 ()
  • 05099590657355 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MICroSTREP Plus Panel Type 2
Beckman Coulter, Inc.
B1027-202
In Commercial Distribution

  • 15099590659646 ()
  • 05099590659649 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
MICroSTREP Plus Panel Type 1
Beckman Coulter, Inc.
B1027-201
In Commercial Distribution

  • 15099590659622 ()
  • 05099590659625 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
ESBL Plus ESBL Confirmation Panel
Beckman Coulter, Inc.
B1027-101
In Commercial Distribution

  • 15099590659608 ()
  • 05099590659601 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
MicroScan Rapid Yeast ID Panel
Beckman Coulter, Inc.
B1017-70
In Commercial Distribution

  • 15099590658106 ()
  • 05099590658109 ()


  • Multiple Candida/yeast species culture isolate identification IVD, kit
Rapid Multi-drug Test CUP-6 panel
Guangzhou Decheng Biotechnology Co., LTD
4831U2X001
Not in Commercial Distribution

  • 06974464590138 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
Back Support Universal Extension Panel
DEROYAL INDUSTRIES, INC.
20-MEP70
In Commercial Distribution

  • 00749756376761 ()
20-MEP70

  • Lumbar spine orthosis
Suntan Unit. One Panel with ten 72" suntan lamps. Panel is wall mounted.
Medtek Lighting Corporation
1000HT
In Commercial Distribution

  • B343HT1000 ()

  • Area/Surface Area: 1311 Square inch
  • Weight: 180 Pound
1000HT

  • Ultraviolet tanning device
DVD, LabPro V4.42 Panel Update-09 (US); LabPro V4.42 Panel Update-09 DVD Kit (US); LabPro V4.42 System Kit w/Panel Update-09 (US)
Beckman Coulter, Inc.
V4.42
In Commercial Distribution

  • 15099590733940 ()
  • 15099590733926 ()
  • 15099590733933 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
DVD, LabPro V4.42 Panel Update-08 (US); LabPro V4.42 Panel Update-08 DVD Kit (US); LabPro V4.42 System Kit w/Panel Update-08 (US)
Beckman Coulter, Inc.
V4.42
In Commercial Distribution

  • 15099590731151 ()
  • 15099590731144 ()
  • 15099590731168 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
The CombiDiagnost R90 is a multi-functional general Radiography/Fluoroscopy (R/F) system.that includes - Adjustable Straps for Patient Support; - Adult headrest; - Ankle Clamps; - Arm Support; - Babix holder vertical stand; - Compression Belt (singles. pull); - Console trolles; - Detector Holder for Patient Bed; - Extra Stitching Ruler; - Hand grips (Pair of); - Handle; - Infusion bottle holder; - Leg Supports (Pair of); - Mattress GXR Systems; - Mobile Detector Holder; - Monitor Ceiling Suspension(Family); - Monitor CS for1 Monitor; - Monitor CS for2 Monitors; - Monitor CS for3 Monitors; - Monitor Trolley Family: - Monitor Trolley for 1 Monitor assembly; - Monitor Trolley for 2 Monitors assembly; - Patient Support for Stitching; - Rotable stool for footrest; - Shoulder supports (Pair of); - Side Bar; - Stretch Grip for VS/VM Stand
Philips Medical Systems DMC GmbH
709031
In Commercial Distribution

  • 00884838101456 ()


  • Indirect flat panel x-ray detector
No Description
ALIMED, INC.
932527
In Commercial Distribution

  • 00733657240313 ()
2970013575

  • Radiation shielding panel, portable/mobile
Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HK701G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
17HK701G-WP
In Commercial Distribution

  • 00719192633148 ()
17HK701G-WP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HK700G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
17HK700G-WP
In Commercial Distribution

  • 00719192633131 ()
17HK700G-WP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 14HK701G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
14HK701G-WP
In Commercial Distribution

  • 00719192633124 ()
14HK701G-WP

  • Indirect flat panel x-ray detector
No Description
LG Electronics Inc.
17HK701G-W
In Commercial Distribution

  • 00719192633117 ()
17HK701G-WA

  • Indirect flat panel x-ray detector
No Description
LG Electronics Inc.
17HK700G-W
In Commercial Distribution

  • 00719192620766 ()
17HK700G-WA

  • Indirect flat panel x-ray detector
No Description
LG Electronics Inc.
14HK701G-W
In Commercial Distribution

  • 00719192620759 ()
14HK701G-WA

  • Indirect flat panel x-ray detector
Radiation Shield, Mobile, Adjustable Height, Compact, 1" Lead
BIODEX MEDICAL SYSTEMS, INC.
042-522
In Commercial Distribution

  • 00718175005224 ()
042-522

  • Radiation shielding panel, portable/mobile
Radiation Shield, Mobile, Adjustable Height, 1" Lead
BIODEX MEDICAL SYSTEMS, INC.
042-519
In Commercial Distribution

  • 00718175005194 ()
042-519

  • Radiation shielding panel, portable/mobile
BARRIER, CLEAR-LEAD, 54.5"Hx30"W,0.5mmPb
BIODEX MEDICAL SYSTEMS, INC.
042-582
Not in Commercial Distribution

  • 00718175000083 ()
042-582

  • Radiation shielding panel, portable/mobile
BARRIER, CLEAR-LEAD, 24"Hx30"W, 0.5mm Pb
BIODEX MEDICAL SYSTEMS, INC.
042-580
Not in Commercial Distribution

  • 00718175000076 ()
042-580

  • Radiation shielding panel, portable/mobile
BARRIER, CLEAR-LEAD, 23"Hx48"W, 1.0mmPb
BIODEX MEDICAL SYSTEMS, INC.
042-585
Not in Commercial Distribution

  • 00718175000069 ()
042-585

  • Radiation shielding panel, portable/mobile
Mobile Radiation Shield
Rampart Ic, LLC
M1128-RTV-02
In Commercial Distribution

  • 00860010101209 ()
M1128-RTV-2

  • Radiation shielding panel, portable/mobile
Radiation Protection Shield
RADUX DEVICES, LLC
SS0100
Not in Commercial Distribution

  • 10853714008032 ()
  • 00853714008035 ()
SS0100

  • Radiation shielding panel, portable/mobile
IDI,RADIATION PROTECTION SYSTEM,LEADED ACRYLIC WINDOW,COMPASS CONTOUR SUSPENSION,SINGLE ARM,130MM THREADED HARDWARE#A610-0211-130
IMAGE DIAGNOSTICS, INC.
Compass Contour Suspended System with 1 Arm
In Commercial Distribution

  • 00850061871367 ()
A610-0211-130

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,TOSHIBA,ARTICULATING RADIATION SHIELD#A800-0007-TS02
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Toshiba Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850061871343 ()
A800-0007-TS02

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,PHILIPS,ARTICULATING RADIATION SHIELD#A800-0006-PH02
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Small Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850061871336 ()
A800-0006-PH02

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,SIEMENS ICONO,ARTICULATING RADIATION SHIELD#A800-0004-SII02
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Large Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850061871329 ()
A800-0004-SII02

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,SIEMENS ICONO,MOBILE BARRIER#A800-0004-SII01
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Large Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850061871312 ()
A800-0004-SII01

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,SIEMENS ARTIS,ARTICULATING RADIATION SHIELD#A800-0004-SAI02
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Large Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850061871305 ()
A800-0004-SAI02

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,GE INNOVA,ARTICULATING RADIATION SHIELD#A800-0002-GE02
IMAGE DIAGNOSTICS, INC.
Protego MRS System for GE Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850061871299 ()
A800-0002-GE02

  • Radiation shielding panel, portable/mobile
IDI,PROTEGO,PAD,SCATTER SHIELD,RADIAL ARM,CASE OF 15,#X800-0147
IMAGE DIAGNOSTICS, INC.
RADIAL ARM BOARD RADIATION SHIELD PAD
In Commercial Distribution

  • 00850061871077 ()
  • 00850061871084 ()
X800-0147

  • Radiation shielding panel, portable/mobile
IDI,PROTEGO,PAD,SCATTER SHIELD,FEMORAL,CASE OF 15,#X800-0251
IMAGE DIAGNOSTICS, INC.
FEMORAL SHIELD RADIATION SHIELD PAD
In Commercial Distribution

  • 00850061871091 ()
  • 00850061871107 ()
X800-0251

  • Radiation shielding panel, portable/mobile
IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,TOSHIBA,MOBILE BARRIER#A800-0007-TS01
IMAGE DIAGNOSTICS, INC.
Protego MRS System for Toshiba Table Tops w/Metric Accessory Rails
In Commercial Distribution

  • 00850977007973 ()
A800-0007-TS01

  • Radiation shielding panel, portable/mobile
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