SOMATEX Medical Technologies GmbH
Blankenfelde-Mahlow Brandenburg, DE
SOMATEX Medical Technologies GmbH appears in FDA device records in Blankenfelde-Mahlow Brandenburg, DE. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for SOMATEX Medical Technologies GmbH between 2008 and 2021. The busiest year on record is 2011, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2018 | 2 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201863 | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape | NEU | Substantially Equivalent | |
| K182082 | Tumark for Eviva, Tumark for Brevera | NEU | Substantially Equivalent | |
| K180443 | Tumark Vision | NEU | Substantially Equivalent | |
| K111692 | TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC | NEU | Substantially Equivalent | |
| K102771 | BIOPSY HANDY, MRI BIOPSY HANDY | KNW | Substantially Equivalent | |
| K093064 | TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 | NEU | Substantially Equivalent | |
| K073095 | TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 | NEU | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014090621 | 3014090621 | SOMATEX Medical Technologies GmbH | Blankenfelder Dorfstrasse 94, Blankenfelde-Mahlow Brandenburg 15827 DE | 2026 | |
| 3030927217 | 3030927217 | SOMATEX Medical Technologies GmbH | Kaiserin-Augusta-Allee 112/113, Berlin 10553 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1200-2021 | Thread-like wire marker | This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body. | Class II | Terminated | |
| Z-0410-2018 | TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE | There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain