ClearanceBrief
Company · DE

Heraeus Medical GmbH

FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2024. Name variants (Inc, Corp, punctuation) are merged.

13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
LODBone Cement9
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1
KWLProsthesis, Hip, Hemi-, Femoral, Metal1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 5, 2024K241674OSTEOPAL® V
Heraeus Medical GmbH, DE
LOD
Feb 15, 2024K234028COPAL® exchange G hip spacer; COPAL® G+V
Heraeus Medical GmbH, DE
KWL
Feb 4, 2023K222570COPAL knee moulds
Heraeus Medical GmbH, DE
JWH
Mar 23, 2022K220492COPAL exchange G hip spacer
Heraeus Medical GmbH, DE
KWY
Feb 2, 2022K213812PALACOS MV pro
Heraeus Medical GmbH, DE
LOD
Jul 9, 2021K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
Heraeus Medical GmbH, DE
LOD
Nov 23, 2020K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
Heraeus Medical GmbH, DE
LOD
Nov 1, 2019K191016COPAL exchange G Hip and Knee Spacers
Heraeus Medical GmbH, DE
KWY
May 31, 2019K190766PALACOS fast R+G
Heraeus Medical GmbH, DE
LOD
Sep 17, 2018K182260PALACOS MV
Heraeus Medical GmbH, DE
LOD
Apr 22, 2016K153737OSTEOPAL plus
Heraeus Medical GmbH, DE
LOD
Jun 17, 2015K150119PALACOS R pro
Heraeus Medical GmbH, DE
LOD
Sep 5, 2014K142157PALACOS R+G PRO
Heraeus Medical GmbH, DE
LOD

Latest recalls

DateFirm and productCodeLinked 510(k)
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