510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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AKTORmed GmbH

Neutraubling Bavaria, DE

AKTORmed GmbH appears in FDA device records in Neutraubling Bavaria, DE. FDA records list 5 510(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) clearances
5
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for AKTORmed GmbH between 2018 and 2026. The busiest year on record is 2024, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for AKTORmed GmbH, by decision year
YearClearances
20181
20201
20242
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261573ENDOSCOPE HOLDER (182214)QZBSubstantially Equivalent
K233312SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894QZBSubstantially Equivalent
K232405ENDOFIX EXOOCVSubstantially Equivalent
K200473SoloAsisst II, Voice ControlNAYSubstantially Equivalent
K171947SOLOASSIST IINAYSubstantially Equivalent

Registered establishments

FDA registered establishments for AKTORmed GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30113900763011390076AKTORmed GmbHNeugablonzer Strasse 13, Neutraubling Bavaria 93073 DE2026

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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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain