Medcom GmbH
Darmstadt Hesse, DE
MEDCOM GMBH appears in FDA device records in Darmstadt Hesse, DE. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no 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 12 510(k) clearances for Medcom GmbH between 1983 and 2018. The busiest year on record is 2010, with 2. The most recent is 2018, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2014 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K181789 | VeriSuite | LHN | Substantially Equivalent | |
| K180308 | Prelude | MUJ | Substantially Equivalent | |
| K170841 | BiopSee, Mobile US | LLZ | Substantially Equivalent | |
| K163119 | NaviSuite SSI Edition | LLZ | Substantially Equivalent | |
| K133914 | VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE | LHN | Substantially Equivalent | |
| K102237 | PVS MODEL 1.0 | IYE | Substantially Equivalent | |
| K100056 | MEDCOM RT-VIEWER SYSTEM | MUJ | Substantially Equivalent | |
| K092653 | VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 | LHN | Substantially Equivalent | |
| K080742 | VERISUITE 1.6, VERISUITE-PARTICLE 1.6 | IYE | Substantially Equivalent | |
| K032550 | EXOMIO, MODEL 2.0 SP1 | KPQ | Substantially Equivalent | |
| K022219 | EXOMIO, MODEL 1.1 | KPQ | Substantially Equivalent | |
| K830324 | AIRCARE 300 | CAW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006579682 | 3006579682 | MEDCOM GMBH | Dolivostrasse 11, Darmstadt Hesse 64293 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain