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

Sao Paulo, BR

TIMPEL S.A. appears in FDA device records in Sao Paulo, BR. FDA records list 4 510(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
4
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 4 510(k) clearances for Timpel S.A. between 2018 and 2025. The busiest year on record is 2018, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Timpel S.A., by decision year
YearClearances
20181
20221
20231
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250464Enlight 2100 (TPL-E2103-0)QEBSubstantially Equivalent
K222897Enlight 2100QEBSubstantially Equivalent
K211135Enlight 2100QEBSubstantially Equivalent
DEN170072Enlight 1810QEBUnknown

Registered establishments

FDA registered establishments for Timpel S.A., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30138536743013853674TIMPEL S.A.R. Simao Alvares, 356 cj. 41 - Pinheiros, Sao Paulo 05417-020 BR2026
30165097613016509761TIMPEL S.A.Rua Jose Leonardi 280 Bloco A, Pato Branco Parana 85503 BR2026

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