510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Assut Europe S.p.A.

Magliano Dei Marsi L'Aquila, IT

Assut Europe S.P.A. appears in FDA device records in Magliano Dei Marsi L'Aquila, IT. FDA records list 3 510(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
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Assut Europe S.p.A. between 2002 and 2017. The busiest year on record is 2002, with 1. The most recent is 2017, with 1.

Clearances by year, as a table
510(k) clearance decisions for Assut Europe S.p.A., by decision year
YearClearances
20021
20161
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K171039Assut Filbloc Permanent SuturesGAWSubstantially Equivalent
K150553FilblocNEWSubstantially Equivalent
K021767ASSUFILGAMSubstantially Equivalent

Registered establishments

FDA registered establishments for Assut Europe S.p.A., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96175473003272809Assut Europe S.P.A.Zona Industriale, Magliano Dei Marsi L'Aquila AQ I-67062 IT2026

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