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

MEDOLLA Modena, IT

RAND S.p.A. appears in FDA device records in MEDOLLA Modena, IT. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 recalls 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
2
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for RAND S.p.A. in 2016.

Clearances by year, as a table
510(k) clearance decisions for RAND S.p.A., by decision year
YearClearances
20161
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K161613Hang&Go PACLGZSubstantially Equivalent

Registered establishments

FDA registered establishments for RAND S.p.A., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30037938913003793891RAND S.p.A.VIA STATALE 12, 62, MEDOLLA Modena 41036 IT2026

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-2049-2021Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.Class IITerminated
Z-2048-2021Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain