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

Independence, OH, US

RULTRACT INC appears in FDA device records in Independence, OH. FDA records list no 510(k) clearances, 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
0
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for Rultract Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
15305043000717741RULTRACT INC5663 Brecksville Road, Independence, OH 44131 US2026

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-0008-04Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.Terminated

Verification record

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