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

Netanya Tel Aviv, IL

NOVOXEL INC. appears in FDA device records in Netanya Tel Aviv, IL. 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 Novoxel Inc. between 2021 and 2024. The busiest year on record is 2021, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Novoxel Inc., by decision year
YearClearances
20211
20231
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K240512Tixel i (TXLI0001)ORZSubstantially Equivalent
K223033Tixel® 2 SystemGEISubstantially Equivalent
K202988Tixel SystemGEISubstantially Equivalent

Registered establishments

FDA registered establishments for Novoxel Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30308477933030847793NOVOXEL INC.2627 Ne 203rd St Ste 102, Aventura, FL 33180 US2026No device listings on this registration
30141930783014193078NOVOXEL LTD.43 Hamelaha Street, Netanya Tel Aviv 4250573 IL2026

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