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

Heidelberg Baden-Wurttemberg, DE

MINT MEDICAL GMBH appears in FDA device records in Heidelberg Baden-Wurttemberg, DE. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
3
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Mint Medical GmbH in 2015.

Clearances by year, as a table
510(k) clearance decisions for Mint Medical GmbH, by decision year
YearClearances
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K142647mint LesionLLZSubstantially Equivalent

Registered establishments

FDA registered establishments for Mint Medical GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30117060183011706018MINT MEDICAL GMBHKurfuersten-Anlage 21, Heidelberg Baden-Wurttemberg 69115 DE2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2068-2026Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.Class IIOpen, Classified
Z-0710-2025mint Lesion, Software Versions: 3.10.0 and 3.10.1.Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.Class IIOpen, Classified
Z-0709-2025mint Lesion, Software Versions: 3.9.0 through 3.9.5.Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.Class IIOpen, Classified

Verification record

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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