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Heraeus Medical GmbH: FDA-registered device maker in WEHRHEIM Hesse, Germany, 19 510(k) clearances

Heraeus Medical GmbH is registered with the FDA (registration 3006406161) in WEHRHEIM Hesse, Germany. It lists 10 device types. The FDA files 19 510(k) clearances under its listings, the newest dated December 5, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Heraeus Medical GmbH
FDA registration number
3006406161
Address
Philipp-Reis-Strasse 8/13, WEHRHEIM Hesse, Germany, D-61273
Owner or operator
Heraeus Medical GmbH (10048423)
Roles
Manufacturer
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 CementLOD2Manufactureraccessdata.fda.gov
Bone Cement, AntibioticMBB2Manufactureraccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Manufactureraccessdata.fda.gov
Dispenser, CementKIH1Manufactureraccessdata.fda.gov
Evacuator, Vapor, Cement MonomerJDY1Manufactureraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Manufactureraccessdata.fda.gov
TemplateHWT1Manufactureraccessdata.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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 20, 202699708Class IIOngoingPALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or withPotential for monomer liquid leakage.accessdata.fda.gov
March 25, 202698608Class IIIOngoingHeraeus, PALAMIX uno. Material Number: 66057893.Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).accessdata.fda.gov
December 9, 202598078Class IIOngoingBrand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-fincrease of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since accessdata.fda.gov

Compare with other makers

Updated September 25, 2026. 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.