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

Zurich, CH

ZURIMED TECHNOLOGIES AG appears in FDA device records in Zurich, CH. FDA records list 2 510(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
2
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 2 510(k) clearances for Zurimed Technologies AG between 2024 and 2026. The busiest year on record is 2024, with 1. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Zurimed Technologies AG, by decision year
YearClearances
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitOWXSubstantially Equivalent
K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)OWXSubstantially Equivalent

Registered establishments

FDA registered establishments for Zurimed Technologies AG, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30349324593034932459ZURIMED TECHNOLOGIES AGLengghalde 5, Zurich 8008 CH2026
30349915163034991516ZURIMED TECHNOLOGIES INC.1111B S Governors Ave, STE 21888, Dover, DE 19904 US2026No device listings on this registration

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