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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BiPAP A40 Pro, CA
Respironics, Inc.
CAX3100S12
In Commercial Distribution

  • 00606959059405 ()
CAX3100S12

  • Portable electric ventilator
USB,AUDIGY 2.1,CA
Gn Hearing A/S
20813321
In Commercial Distribution

  • 05708296099818 ()


  • Audiometric/hearing device software
ARCHITECT CA 15-3 Calibrators
Abbott GmbH
02K4402
In Commercial Distribution

  • 00380740145293 ()
02K4402

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
ARCHITECT CA 15-3 Controls
Abbott GmbH
02K4411
In Commercial Distribution

  • 00380740145309 ()
02K4411

  • Cancer antigen 15-3 (CA15-3) IVD, control
Maxima ELITE Electric CA
HENRY SCHEIN, INC.
1125681
In Commercial Distribution

  • 00304040058015 ()
1125681

  • Dental power tool converter attachment, rotary
E-Type Reduction CA Sheath
HENRY SCHEIN, INC.
1026953
In Commercial Distribution

  • 00304040057827 ()
1026953

  • Dental power tool system handpiece, pneumatic
IRISpec CA/CB Twinset
IRIS INTERNATIONAL, INC.
CA/CB Twinset
Not in Commercial Distribution

  • 10837461001973 ()
800-7211

  • Multiple urine analyte IVD, control
O3/AG/OT/CA
BSN-Jobst GmbH
73553-00000-00
In Commercial Distribution

  • 04019702244878 ()

  • Pressure 34-46 mmHg


  • Compression/pressure sock/stocking, reusable
E2/CG1/NOP2,5-T-ZI/CA
BSN-Jobst GmbH
77559-00030-00
In Commercial Distribution

  • 04019702288353 ()

  • Pressure 23-32 mmHg


  • Compression/pressure sock/stocking, reusable
E1/CG1/NOP-I-ZI/CA
BSN-Jobst GmbH
77331-00019-00
In Commercial Distribution

  • 04019702300598 ()

  • Pressure 15-21 mmHg


  • Compression/pressure sock/stocking, reusable
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