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

Wrentham, MA, US

NOVUS SCIENTIFIC AB appears in FDA device records in Wrentham, MA. FDA records list 3 510(k) clearances between and , no PMA records and 2 registered establishments. 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
3
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 3 510(k) clearances for Novus Scientific AB between 2010 and 2020. The busiest year on record is 2010, with 1. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Novus Scientific AB, by decision year
YearClearances
20101
20171
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshOWTSubstantially Equivalent
K163005TIGR Matrix Surgical MeshOWTSubstantially Equivalent
K092224TIGR SURGICAL MESH , MODEL WK-6FTLSubstantially Equivalent

Registered establishments

FDA registered establishments for Novus Scientific AB, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30101872633010187263NOVUS SCIENTIFIC ABVirdings Alle 2, Uppsala 754 50 SE2026
30095148423009514842NOVUS SCIENTIFIC INC190 Industrial Road, Wrentham, MA 02093 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-2603-2016TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs.Class IITerminated

Verification record

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