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Data / Medical devices / United States / Heraeus Medical LLC

Heraeus Medical LLC: FDA-registered device maker in Yardley, PA, United States, 19 510(k) clearances

Heraeus Medical LLC is registered with the FDA (registration 3013186738) in Yardley, PA, United States. It lists 10 device types. The FDA files 19 510(k) clearances under its listings, the newest dated December 5, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Heraeus Medical LLC
FDA registration number
3013186738
Address
Township Line Road 770, Suite 300, Yardley, PA, United States, 19067
Owner or operator
Heraeus Medical GmbH (10048423)
Roles
Complaint file establishment
First device listed
January 12, 2015
Registered through
2026
Brand names listed
COPAL exchange G hip spacer, COPAL® exchange G, COPAL® exchange G Trial Sets, COPAL® knee mould Trial L US, COPAL® knee mould Trial M US, COPAL® knee mould Trial S US, OSTEOPAL V, OSTEOPAL® plus and more

Devices it lists

DeviceProduct codeClassRoleSource
Bone CementLOD2Complaint file establishmentaccessdata.fda.gov
Bone Cement, AntibioticMBB2Complaint file establishmentaccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Complaint file establishmentaccessdata.fda.gov
Dispenser, CementKIH1Complaint file establishmentaccessdata.fda.gov
Evacuator, Vapor, Cement MonomerJDY1Complaint file establishmentaccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Complaint file establishmentaccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Complaint file establishmentaccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Complaint file establishmentaccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Complaint file establishmentaccessdata.fda.gov
TemplateHWT1Complaint file establishmentaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 5, 2024K241674OSTEOPAL® VLODSubstantially EquivalentHeraeus Medical GmbHaccessdata.fda.gov
February 15, 2024K234028COPAL® exchange G hip spacer; COPAL® G+VKWLSubstantially EquivalentHeraeus Medical GmbHaccessdata.fda.gov
March 23, 2022K220492COPAL exchange G hip spacerKWYSubstantially EquivalentHeraeus Medical GmbHaccessdata.fda.gov
February 2, 2022K213812PALACOS MV proLODSubstantially EquivalentHeraeus Medical GmbHaccessdata.fda.gov
July 9, 2021K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proLODSubstantially EquivalentHeraeus Medical GmbHaccessdata.fda.gov
November 23, 2020K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+GLODSubstantially EquivalentHeraeus Medical GmbHaccessdata.fda.gov
November 1, 2019K191016COPAL exchange G Hip and Knee SpacersKWYSubstantially EquivalentHeraeus Medical GmbHaccessdata.fda.gov
May 31, 2019K190766PALACOS fast R+GLODSubstantially EquivalentHeraeus Medical GmbHaccessdata.fda.gov
September 17, 2018K182260PALACOS MVLODSubstantially EquivalentHeraeus Medical GmbHaccessdata.fda.gov
April 22, 2016K153737OSTEOPAL plusLODSubstantially EquivalentHeraeus Medical GmbHaccessdata.fda.gov
June 17, 2015K150119PALACOS R proLODSubstantially EquivalentHeraeus Medical GmbHaccessdata.fda.gov
September 5, 2014K142157PALACOS R+G PROLODSubstantially EquivalentHeraeus Medical GmbHaccessdata.fda.gov
September 14, 2005K050085OSTEOPAL VLODSubstantially EquivalentHeraeus Kulzer,GmbHaccessdata.fda.gov
July 7, 2005K050855PALAMED GLODSubstantially EquivalentHeraeus Kulzer,GmbHaccessdata.fda.gov
July 7, 2005K050854PALACOS LV+GLODSubstantially EquivalentHeraeus Kulzer,GmbHaccessdata.fda.gov
May 25, 2004K031673REFOBACIN -PALACOS GLODSubstantially EquivalentHeraeus Kulzer GmbH & Co. KGaccessdata.fda.gov
September 23, 2003K030904PALAMEDLODSubstantially EquivalentHeraeus Medical GmbH Technologyaccessdata.fda.gov
September 23, 2003K030903OSTEOPALLODSubstantially EquivalentHeraeus Kulzer GmbH & Co. KGaccessdata.fda.gov
September 23, 2003K030902PALACOS RLODSubstantially EquivalentHeraeus Kulzer GmbH & Co. KGaccessdata.fda.gov

Compare with other makers

Updated December 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.