Heraeus Medical GmbH

FDA Device Registration & Listing · WEHRHEIM Hesse, DE · Registration 3006406161

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006406161
FEI Number
3006406161
Entity Name
Heraeus Medical GmbH
City/State/Country
WEHRHEIM Hesse, DE
Establishment Address
PHILIPP-REIS-STRASSE 8/13, WEHRHEIM Hesse D-61273, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Heraeus Medical GmbH (Owner Number: 10048423)
Owner / Operator Contact Address
Philipp-Reis-Str. 8/13, Wehrheim, DE-HE 61273, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K210607
PMA Number
N/A

All Registered Proprietary Names

PALACOS® R+G pro PALACOS R pro PALACOS MV Palacos LV® + G PALAMIX Cement Gun PALAMIX Nozzle Slim PALAMIX Nozzle Medium pro nozzle medium pro nozzle short with knee pressuriser PALAMIX UNO PALAMIX DUO PALACOS® fast R+G OSTEOPAL V PALACOS® LV Osteopal® COPAL® exchange G Trial Sets COPAL® knee mould Trial S US COPAL® knee mould Trial L US COPAL® knee mould Trial M US Palamed® PALACOS® MV Osteopal® V PALACOS® R+G Palacos G PALACOS® R pro PALACOS® MV+G pro PALACOS® R+G pro

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2015-01-13
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2015-01-13
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2015-01-13
LOD Bone Cement Orthopedic Class 2 888.3027 2015-01-13
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2015-08-27
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2015-08-27
LOD Bone Cement Orthopedic Class 2 888.3027 2015-08-27
LOD Bone Cement Orthopedic Class 2 888.3027 2018-09-19
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2015-01-12
LOD Bone Cement Orthopedic Class 2 888.3027 2015-01-12
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2017-11-20
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2017-12-01
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2019-06-03
LOD Bone Cement Orthopedic Class 2 888.3027 2019-06-03
LOD Bone Cement Orthopedic Class 2 888.3027 2025-01-15
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2025-01-15
LOD Bone Cement Orthopedic Class 2 888.3027 2015-01-12
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2024-05-06
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2024-05-06
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2024-05-06
HWT Template Orthopedic Class 1 888.4800 2020-07-01
LOD Bone Cement Orthopedic Class 2 888.3027 2015-01-12
LOD Bone Cement Orthopedic Class 2 888.3027 2015-01-12
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2015-01-12
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2015-01-13
LOD Bone Cement Orthopedic Class 2 888.3027 2015-01-13
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2021-07-12
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2021-07-12
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2021-07-12
LOD Bone Cement Orthopedic Class 2 888.3027 2021-07-12

Official Correspondent

Benjamin Hagedorn

US Agent Details

Devin Childers Business: Heraeus Medical LLC Email: devin.childers@heraeus.com Phone: (215) 5944927

Related Public Records

Same Entity

Heraeus Medical GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013186738 Heraeus Medical LLC Yardley, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K823482 Intermedics Orthopedics 101 UNIVERSAL ENDOPROSTHESIS 1983-02-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006406161. Last updated year: 2026. Please use registration number 3006406161 when referencing this establishment in official correspondence.
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