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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
Edwards Lifesciences LLC
9355FS23
In Commercial Distribution

  • 00690103193220 ()

  • 23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9355FS23A

  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
EDWARDS BALLOON CATHETER
Edwards Lifesciences LLC
9350BC23
In Commercial Distribution

  • 00690103191820 ()

  • 23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9350BC23A

  • Cardiac valvuloplasty catheter
EDWARDS BALLOON CATHETER
Edwards Lifesciences LLC
9350BC20
In Commercial Distribution

  • 00690103191813 ()

  • 20 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9350BC20A

  • Cardiac valvuloplasty catheter
Stackable Steptool Footstool 24 x 12 x 8
Batrik Medical Manufacturing Inc
OR-36360-B
In Commercial Distribution

  • 00690521014893 ()
OR-36360-B

  • Footstool
No Description
DATASCOPE CORP.
BEQ- 20102
Not in Commercial Distribution

  • 00607567200159 ()
701048429

  • Cardiopulmonary bypass system blood tubing set
Dental Composite resin
Kulzer GmbH
66004969
In Commercial Distribution

  • J014660049691 ()
66004969

  • Dental composite resin
Material Impression
Kulzer GmbH
66004969
Not in Commercial Distribution

  • J014660049690 ()
66004969

  • Polyether dental impression material
Dental Composite resin
Kulzer GmbH
66004965
In Commercial Distribution

  • J014660049651 ()
66004965

  • Dental composite resin
Material Impression
Kulzer GmbH
66004965
Not in Commercial Distribution

  • J014660049650 ()
66004965

  • Polyether dental impression material
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1033-170
In Commercial Distribution

  • 00848665014686 ()


  • Femur nail, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1032-170
In Commercial Distribution

  • 00848665014662 ()


  • Femur nail, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1031-170
In Commercial Distribution

  • 00848665014648 ()


  • Femur nail, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1082-200
In Commercial Distribution

  • 00848665004861 ()


  • Femur nail, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
1082-170
In Commercial Distribution

  • 00848665004854 ()


  • Femur nail, non-sterile
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1041-200
Not in Commercial Distribution

  • 00848665003826 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1041-170
Not in Commercial Distribution

  • 00848665003819 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1040-200
Not in Commercial Distribution

  • 00848665003802 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1040-170
Not in Commercial Distribution

  • 00848665003796 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1037-200
Not in Commercial Distribution

  • 00848665003741 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1037-170
Not in Commercial Distribution

  • 00848665003734 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1036-200
Not in Commercial Distribution

  • 00848665003727 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1036-170
Not in Commercial Distribution

  • 00848665003710 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1034-200
Not in Commercial Distribution

  • 00848665003680 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1034-170
Not in Commercial Distribution

  • 00848665003673 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1033-200
Not in Commercial Distribution

  • 00848665003666 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1033-170
Not in Commercial Distribution

  • 00848665003659 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1032-200
Not in Commercial Distribution

  • 00848665003642 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1032-170
Not in Commercial Distribution

  • 00848665003635 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1031-200
Not in Commercial Distribution

  • 00848665003628 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1031-170
Not in Commercial Distribution

  • 00848665003611 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1030-200
Not in Commercial Distribution

  • 00848665003604 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1030-170
Not in Commercial Distribution

  • 00848665003598 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1029-200
Not in Commercial Distribution

  • 00848665003581 ()


  • Femur intramedullary nail
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S1029-170
Not in Commercial Distribution

  • 00848665003574 ()


  • Femur intramedullary nail
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
246-PEDIHEART
Not in Commercial Distribution

  • 00842430115882 ()
246-PEDIHEART

  • Operating table patient pressure distribution monitoring/regulation system
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69265
In Commercial Distribution

  • 00842430114267 ()
69265

  • Stretcher mattress
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69024
Not in Commercial Distribution

  • 00842430114250 ()
69024

  • Stretcher mattress
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69026
In Commercial Distribution

  • 00842430111044 ()
69026

  • Stretcher mattress
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69295
In Commercial Distribution

  • 00842430111037 ()
69295

  • Stretcher mattress
Dermisplus Prevent Strip 20 x 1 x 0.1in (pk of 5)
Frontier Therapeutics Inc
8500001
In Commercial Distribution

  • 05056279304108 ()


  • Pressure-management bandage, silicone
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