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

Brookings, SD, US

Solventum US LLC appears in FDA device records in Brookings, SD. FDA records list one 510(k) clearance, no PMA records and 8 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
8

510(k) clearance history

FDA records hold 1 510(k) clearance for Solventum US LLC in 2025.

Clearances by year, as a table
510(k) clearance decisions for Solventum US LLC, by decision year
YearClearances
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251866Tegaderm Post-Op Transparent Antimicrobial DressingFROSubstantially Equivalent

Registered establishments

FDA registered establishments for Solventum US LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30422727973042272797SOLVENTUM US LLC1750 Yankee Doodle Rd, Eagan, MN 55121 US2026and 65 more, listed in full below
30317570473031757047Solventum US LLC601 22nd Ave S, Brookings, SD 57006 US2026and 15 more, listed in full below
30318414333031841433Solventum US LLC12930 IH 10 West, San Antonio, TX 78249 US2026and 68 more, listed in full below
30321637163032163716Solventum US LLC2111 McGaw Avenue, Irvine, CA 92614 US2026and 15 more, listed in full below
30334692163033469216Solventum US LLC806 W Crystal Lake Rd, Forest City, IA 50436 US2026No device listings on this registration
30361088473036108847Solventum US LLC10351 West 70th Street, Eden Prairie, MN 55344 US2026
30364971563036497156Solventum US LLC5400 Paris Rd, Columbia, MO 65202 US2026
30365042343036504234Solventum US LLC500 Rt. 202 North, Flemington, NJ 08822 US2026

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