Medical Device Manufacturer · DE , Wehrheim

Heraeus Medical GmbH

13 submissions · 13 cleared · Since 2014
13
Total
13
Cleared
0
Denied

Heraeus Medical GmbH — FDA 510(k) Submissions

Heraeus Medical GmbH has submitted 13 FDA 510(k) premarket notifications since 2014, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Bone Cement, Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Hemi-, Femoral, Metal . Use the specialty filter in the sidebar to narrow results.

13 devices
1–13 of 13
OSTEOPAL? V
K241674 · LOD Bone Cement · Orthopedic
Dec 2024 177d
COPAL? exchange G hip spacer; COPAL? G+V
K234028 · KWL Prosthesis, Hip, Hemi-,... · Orthopedic
Feb 2024 57d
COPAL knee moulds
K222570 · JWH Prosthesis, Knee,... · Orthopedic
Feb 2023 165d
COPAL exchange G hip spacer
K220492 · KWY Prosthesis, Hip, Hemi-,... · Orthopedic
Mar 2022 29d
PALACOS MV pro
K213812 · LOD Bone Cement · Orthopedic
Feb 2022 57d
PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
K210607 · LOD Bone Cement · Orthopedic
Jul 2021 130d
PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
K202475 · LOD Bone Cement · Orthopedic
Nov 2020 87d
COPAL exchange G Hip and Knee Spacers
K191016 · KWY Prosthesis, Hip, Hemi-,... · Orthopedic
Nov 2019 198d
PALACOS fast R+G
K190766 · LOD Bone Cement · Orthopedic
May 2019 67d
PALACOS MV
K182260 · LOD Bone Cement · Orthopedic
Sep 2018 27d
OSTEOPAL plus
K153737 · LOD Bone Cement · Orthopedic
Apr 2016 116d
PALACOS R pro
K150119 · LOD Bone Cement · Orthopedic
Jun 2015 148d
PALACOS R+G PRO
K142157 · LOD Bone Cement · Orthopedic
Sep 2014 30d
Filters
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