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

Warminster, PA, US

INVENT MEDICAL USA, LLC appears in FDA device records in Warminster, PA. FDA records list 3 510(k) clearances between and , no PMA records and 2 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
3
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 3 510(k) clearances for Invent Medical USA, LLC between 2022 and 2024. The busiest year on record is 2022, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Invent Medical USA, LLC, by decision year
YearClearances
20221
20231
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K241957Talee, Talee PostOpMVASubstantially Equivalent
K230444Talee, Talee PostOpMVASubstantially Equivalent
K220681Talee, Talee PostOPMVASubstantially Equivalent

Registered establishments

FDA registered establishments for Invent Medical USA, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30152598543015259854INVENT MEDICAL USA, LLC1800 Mearns Rd Ste Y, Warminster, PA 18974 US2026
30388713953038871395INVENT MEDICAL USA, LLC815 14th St Sw Ste A172, Loveland, CO 80537 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

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