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

Kamen North Rhine-Westphalia, DE

Solventum Germany GmbH appears in FDA device records in Kamen North Rhine-Westphalia, DE. FDA records list one 510(k) clearance, no PMA records and 3 registered establishments. 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
1
PMA records
0
Recall records
0
Registered establishments
3

510(k) clearance history

FDA records hold 1 510(k) clearance for Solventum Germany GmbH in 2026.

Clearances by year, as a table
510(k) clearance decisions for Solventum Germany GmbH, by decision year
YearClearances
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251999Promogran Prisma™ Collagen Matrix with ORC and SilverFROSubstantially Equivalent

Registered establishments

FDA registered establishments for Solventum Germany GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30329118503032911850Solventum Germany GmbHEdisonstrasse 6, Kamen North Rhine-Westphalia 59174 DE2026and 13 more, listed in full below
30356930343035693034Solventum Germany GmbHRingstrasse 14, Kist Bavaria 97270 DE2026and 15 more, listed in full below
96113853002806930Solventum Germany GmbHESPE PLATZ, SEEFELD Bavaria 82229 DE2026and 17 more, listed in full below

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