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

St Priest Rhone, FR

Dilon Technologies France SAS appears in FDA device records in St Priest Rhone, FR. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Dilon Technologies France SAS carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Biomup S.A.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Dilon Technologies France SAS in 2013.

Clearances by year, as a table
510(k) clearance decisions for Dilon Technologies France SAS, by decision year
YearClearances
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K130428COVAMESHFTLSubstantially Equivalent

Registered establishments

FDA registered establishments for Dilon Technologies France SAS, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30077024923007702492Dilon Technologies France SAS8 Allee Irene Joliot Curie, St Priest Rhone 69800 FR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1110-2017RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.Lack of sterility assuranceClass IITerminated

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