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Heraeus Medical LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30131867383013186738Heraeus Medical LLC1Y2026-01-01Township Line Road 770, Suite 300 Yardley PA US 19067

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2110751736309943K241674OSTEOPAL® VLOD2024-12-05
2110751898073753K234028COPAL® exchange G hip spacer; COPAL® G+VKWL2024-02-15
2110751688540951K220492COPAL exchange G hip spacerKWY2022-03-23
2110751216256523K213812PALACOS MV proLOD2022-02-02
2110751549349151K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLOD2021-07-09
2110751437353219K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GLOD2020-11-23
2110751881150784K191016COPAL exchange G Hip and Knee SpacersKWY2019-11-01
2110751997546259K190766PALACOS fast R+GLOD2019-05-31
2110751590004918K182260PALACOS MVLOD2018-09-17
2110751921597341K153737OSTEOPAL plusLOD2016-04-22
2110751153754854K150119PALACOS R proLOD2015-06-17
2110751138719563K142157PALACOS R+G PROLOD2014-09-05
2110751851663477K050855PALAMED GLOD2005-07-07
2110751128525252K050854PALACOS LV+GLOD2005-07-07
2110751844906205K050085OSTEOPAL VLOD2005-09-14
2110751940458230K031673REFOBACIN -PALACOS GLOD2004-05-25
2110751814808732K030904PALAMEDLOD2003-09-23
2110751532185121K030903OSTEOPALLOD2003-09-23
2110751107009544K030902PALACOS RLOD2003-09-23
2110751982465577K022251PALABONDLOD2003-02-26
2110751165556812
2110751252743000
2110751580842194
2110751641736191

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOD172024-12-05
KWY22022-03-23
KWL12024-02-15

GUDID#