ClearanceBrief
Company ยท DE

Somatex Medical Technologies GmbH

FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2021. Name variants (Inc, Corp, punctuation) are merged.

7510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
NEUMarker, Radiographic, Implantable7
KNWInstrument, Biopsy1
MIJNeedle, Tumor Localization1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 18, 2021K201863Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
Somatex Medical Technologies GmbH, DE
NEU
Oct 31, 2018K182082Tumark for Eviva, Tumark for Brevera
Somatex Medical Technologies GmbH, DE
NEU
Mar 22, 2018K180443Tumark Vision
Somatex Medical Technologies GmbH, DE
NEU
Nov 8, 2011K111692TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
Somatex Medical Technologies GmbH, DE
NEU
Jun 24, 2011K102771BIOPSY HANDY, MRI BIOPSY HANDY
Somatex Medical Technologies GmbH
KNW
Feb 17, 2010K093064TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560
Somatex Medical Technologies GmbH
NEU
Mar 19, 2008K073095TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560
Somatex Medical Technologies GmbH
NEU

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 3, 2021Somatex Medical Technologies GMBH
Thread-like wire marker
Terminated		 MIJNone listed
May 22, 2017Somatex Medical Technologies GmbH
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
Terminated		 NEUK073095
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