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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830 Single Panel Knee Immobiliser 9"
VIVE HEALTH LLC
SUP3019BLK9
In Commercial Distribution

  • 10810113570782 ()
  • 00810113570785 ()


  • Knee support orthosis
Operating panel for table top II
Baxter Medical Systems GmbH + Co. KG
1549939
Not in Commercial Distribution

  • 00887761974517 ()


  • Operating room equipment remote control
ANTHEM FEMORAL TRIALS L PANEL SIZE1-6
Smith & Nephew, Inc.
71442135
In Commercial Distribution

  • 00885556613535 ()
71442135

  • Instrument tray, reusable
LEGION FEMORAL TRIALS L PANEL SIZE2-6
Smith & Nephew, Inc.
71442166
In Commercial Distribution

  • 00885556613528 ()
71442166

  • Instrument tray, reusable
ORTHOMATCH POSTERIOR STABILIZED PREPARATION PANEL SIZE1-8
Smith & Nephew, Inc.
71442168
In Commercial Distribution

  • 00885556613504 ()
71442168

  • Instrument tray, reusable
Triage TOX Drug Screen (7 Panel)
QUIDEL CARDIOVASCULAR INC.
94404
Not in Commercial Distribution

  • 30014613337898 ()
94404

  • Multiple drugs of abuse IVD, kit, fluorescent immunoassay
Triage TOX Drug Screen (9 Panel)
QUIDEL CARDIOVASCULAR INC.
94402
Not in Commercial Distribution

  • 30014613337881 ()
94402

  • Multiple drugs of abuse IVD, kit, fluorescent immunoassay
Triage TOX Drug Screen (10 Panel)
QUIDEL CARDIOVASCULAR INC.
94401
Not in Commercial Distribution

  • 30014613337874 ()
94401

  • Multiple drugs of abuse IVD, kit, fluorescent immunoassay
TR2810 Shower panel with thermostatic mixer
Tr Equipment AB
0520070-02
In Commercial Distribution

  • 07350016060110 ()


  • Bathing/changing table, mobile
DOA IA PANEL, cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008511
In Commercial Distribution

  • 00810042684188 ()
18008511

  • Multiple drugs of abuse IVD, control
DOA IA PANEL, cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008510
In Commercial Distribution

  • 00810042684171 ()
18008510

  • Multiple drugs of abuse IVD, control
OF 5 Panel, 3X Cutoff, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200005
In Commercial Distribution

  • 00810042683709 ()
18200005

  • Multiple drugs of abuse IVD, control
OF 5 Panel, Cutoff +50%, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200177
In Commercial Distribution

  • 00810042683655 ()
18200177

  • Multiple drugs of abuse IVD, control
OF 5 Panel, Cutoff -50%, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200176
In Commercial Distribution

  • 00810042683648 ()
18200176

  • Multiple drugs of abuse IVD, control
9 Panel Cutoff -/+ 25%, 5ML KITBOX
BIOCHEMICAL DIAGNOSTICS INC
18002907
In Commercial Distribution

  • 00810042680289 ()
18002907

  • Multiple drugs of abuse IVD, control
25 tests kit; COC Single Panel
EASY HEALTHCARE CORPORATION
EDCO-114
In Commercial Distribution

  • 10810038631407 ()
  • 00810038631400 ()
  • 30810038631401 ()
EDCO-114-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Multi-drug Test Cup, 10 Panel
Guangzhou Decheng Biotechnology Co., LTD
4851U2X001
Not in Commercial Distribution

  • 06974464590152 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Aptima® Mycoplasma genitalium Panel B.
HOLOGIC LTD.
KIT, M GEN PANEL B
In Commercial Distribution

  • 15420045509184 ()
PRD-03837

  • Mycoplasma genitalium nucleic acid IVD, reagent
Neg Urine Combo Panel Type 78
Beckman Coulter, Inc.
B1017-430
Not in Commercial Distribution

  • 15099590658052 ()
  • 05099590658055 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 77
Beckman Coulter, Inc.
B1017-429
In Commercial Distribution

  • 15099590658045 ()
  • 05099590658048 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 76
Beckman Coulter, Inc.
B1017-428
Not in Commercial Distribution

  • 15099590658038 ()
  • 05099590658031 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 75
Beckman Coulter, Inc.
B1017-427
In Commercial Distribution

  • 15099590658021 ()
  • 05099590658024 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 74
Beckman Coulter, Inc.
B1017-426
In Commercial Distribution

  • 15099590658014 ()
  • 05099590658017 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 73
Beckman Coulter, Inc.
B1017-423
In Commercial Distribution

  • 15099590657987 ()
  • 05099590657980 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Breakpoint Combo Panel Type 47
Beckman Coulter, Inc.
B1017-417
In Commercial Distribution

  • 15099590657932 ()
  • 05099590657935 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 62
Beckman Coulter, Inc.
B1017-416
In Commercial Distribution

  • 15099590657925 ()
  • 05099590657928 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 61
Beckman Coulter, Inc.
B1017-414
In Commercial Distribution

  • 15099590657918 ()
  • 05099590657911 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 60
Beckman Coulter, Inc.
B1017-413
In Commercial Distribution

  • 15099590657901 ()
  • 05099590657904 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Breakpoint Combo Panel Type 44
Beckman Coulter, Inc.
B1017-411
Not in Commercial Distribution

  • 15099590657888 ()
  • 05099590657881 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
Neg Urine Combo Panel Type 55
Beckman Coulter, Inc.
B1017-409
In Commercial Distribution

  • 15099590657871 ()
  • 05099590657874 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
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