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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Articulating Surfaces, PS+
WALDEMAR LINK GmbH & Co. KG
880-225/11
In Commercial Distribution

  • 04026575254002 ()
880-225/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS+
WALDEMAR LINK GmbH & Co. KG
880-224/11
In Commercial Distribution

  • 04026575253883 ()
880-224/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS+
WALDEMAR LINK GmbH & Co. KG
880-223/11
In Commercial Distribution

  • 04026575253821 ()
880-223/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS+
WALDEMAR LINK GmbH & Co. KG
880-221/11
In Commercial Distribution

  • 04026575253517 ()
880-221/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS
WALDEMAR LINK GmbH & Co. KG
880-219/11
In Commercial Distribution

  • 04026575253432 ()
880-219/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS
WALDEMAR LINK GmbH & Co. KG
880-217/11
In Commercial Distribution

  • 04026575253289 ()
880-217/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS
WALDEMAR LINK GmbH & Co. KG
880-215/11
In Commercial Distribution

  • 04026575253166 ()
880-215/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS
WALDEMAR LINK GmbH & Co. KG
880-214/11
In Commercial Distribution

  • 04026575253012 ()
880-214/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS
WALDEMAR LINK GmbH & Co. KG
880-213/11
In Commercial Distribution

  • 04026575252954 ()
880-213/11

  • Uncoated knee tibia prosthesis, polyethylene
Articulating Surfaces, PS
WALDEMAR LINK GmbH & Co. KG
880-212/11
In Commercial Distribution

  • 04026575252893 ()
880-212/11

  • Uncoated knee tibia prosthesis, polyethylene
SENTINEL V11.X UPGRADE
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129506 ()
040-5172-00

  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129438 ()
040-1708-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 RDT TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129414 ()
040-1725-01

  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT DE
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129407 ()
040-1756-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT DN
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinel 11
Not in Commercial Distribution

  • 10841522129391 ()
040-1755-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT NL
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129384 ()
040-1754-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT BR-PT
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129377 ()
040-1753-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT PL
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129360 ()
040-1752-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT SV
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129353 ()
040-1751-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT ES
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129346 ()
040-1750-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT IT
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129339 ()
040-1749-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
PATHFINDER SL/SENTINEL 11 EVAL SYSTEM (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129322 ()
040-1726-02

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT FR
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129315 ()
040-1748-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 NETWORKED TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129292 ()
040-1723-01

  • Cardiology information system application software
SENTINEL 11 STANDALONE TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129285 ()
040-1722-01

  • Cardiology information system application software
SENTINEL SOFTWARE V11
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinel 11
In Commercial Distribution

  • 10841522125751 ()
98201

  • Cardiology information system application software
Modular Stem, Conical
WALDEMAR LINK GmbH & Co. KG
15-2958/11
In Commercial Distribution

  • 04026575276158 ()
15-2958/11

  • Knee femur stem prosthesis
Modular Stem, Conical
WALDEMAR LINK GmbH & Co. KG
15-2954/11
In Commercial Distribution

  • 04026575275977 ()
15-2954/11

  • Knee femur stem prosthesis
Modular Stem, Conical
WALDEMAR LINK GmbH & Co. KG
15-2953/11
In Commercial Distribution

  • 04026575275038 ()
15-2953/11

  • Knee femur stem prosthesis
Adapter, femoral, proximal
WALDEMAR LINK GmbH & Co. KG
15-6149/11
In Commercial Distribution

  • 04026575274376 ()
15-6149/11

  • Orthopaedic implant-instrument extension adaptor, reusable
Instrument tray - TrabecuLink Augmente
WALDEMAR LINK GmbH & Co. KG
185-100/11
In Commercial Distribution

  • 04026575274147 ()


  • Instrument tray, reusable
Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, standard, pure hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-2362/11
In Commercial Distribution

  • 04026575268009 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, cemented, CoCrMo, UHMWPE, Ti6Al4V, standard, pure hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-2361/11
In Commercial Distribution

  • 04026575267989 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, TiNbN coating, cemented, CoCrMo, UHMWPE, standard, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-9324/11
In Commercial Distribution

  • 04026575267828 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, TiNbN coating, cemented, CoCrMo, UHMWPE, standard, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-9322/11
In Commercial Distribution

  • 04026575267804 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, TiNbN coating, cemented, CoCrMo, UHMWPE, standard, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-9320/11
In Commercial Distribution

  • 04026575267781 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, cemented, CoCrMo, UHMWPE, standard, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-8330/11
In Commercial Distribution

  • 04026575267767 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, cemented, CoCrMo, UHMWPE, standard, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-8324/11
In Commercial Distribution

  • 04026575267743 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, cemented, CoCrMo, UHMWPE, standard, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-8322/11
In Commercial Distribution

  • 04026575267729 ()


  • Uncoated knee femur prosthesis, metallic
Femoral component, cemented, CoCrMo, UHMWPE, standard, rotating hinge (EVO)
WALDEMAR LINK GmbH & Co. KG
15-8320/11
In Commercial Distribution

  • 04026575267705 ()


  • Uncoated knee femur prosthesis, metallic
Orthopaedic broach - TrabecuLink Femoral and Tibial Cone
WALDEMAR LINK GmbH & Co. KG
15-6146/11
In Commercial Distribution

  • 04026575265732 ()


  • Orthopaedic broach
Orthopaedic broach - TrabecuLink Femoral and Tibial Cone
WALDEMAR LINK GmbH & Co. KG
15-6142/11
In Commercial Distribution

  • 04026575265657 ()


  • Orthopaedic broach
Modular Stem, Cylindrical Press-Fit, 6 mm Offset
WALDEMAR LINK GmbH & Co. KG
880-625/11
In Commercial Distribution

  • 04026575264513 ()
880-625/11

  • Knee tibia stem prosthesis
Modular Stem, Cylindrical Press-Fit, 6 mm Offset
WALDEMAR LINK GmbH & Co. KG
880-623/11
In Commercial Distribution

  • 04026575264407 ()
880-623/11

  • Knee tibia stem prosthesis
Modular Stem, Cylindrical Press-Fit, 6 mm Offset
WALDEMAR LINK GmbH & Co. KG
880-621/11
In Commercial Distribution

  • 04026575263646 ()
880-621/11

  • Knee tibia stem prosthesis
Modular Stem, Cylindrical Press-Fit, 3 mm Offset
WALDEMAR LINK GmbH & Co. KG
880-615/11
In Commercial Distribution

  • 04026575263134 ()
880-615/11

  • Knee tibia stem prosthesis
Modular Stem, Cylindrical Press-Fit, 3 mm Offset
WALDEMAR LINK GmbH & Co. KG
880-613/11
In Commercial Distribution

  • 04026575263035 ()
880-613/11

  • Knee tibia stem prosthesis
Modular Stem, Cylindrical Press-Fit, 3 mm Offset
WALDEMAR LINK GmbH & Co. KG
880-611/11
In Commercial Distribution

  • 04026575262830 ()
880-611/11

  • Knee tibia stem prosthesis
Modular Stem, Cylindrical Press-Fit
WALDEMAR LINK GmbH & Co. KG
880-605/11
In Commercial Distribution

  • 04026575261796 ()
880-605/11

  • Knee tibia stem prosthesis
Modular Stem, Cylindrical Press-Fit
WALDEMAR LINK GmbH & Co. KG
880-603/11
In Commercial Distribution

  • 04026575261697 ()
880-603/11

  • Knee tibia stem prosthesis
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