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

Miami Lakes, FL, US

BIOREP TECHNOLOGIES, INC. appears in FDA device records in Miami Lakes, FL. 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

510(k) clearance history

FDA records hold 1 510(k) clearance for Biorep Technologies, Inc. in 2021.

Clearances by year, as a table
510(k) clearance decisions for Biorep Technologies, Inc., by decision year
YearClearances
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K210006MI DeTACHDXCSubstantially Equivalent

Registered establishments

FDA registered establishments for Biorep Technologies, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30055936753005593675BIOREP TECHNOLOGIES, INC.15804 NW 57th Ave, Miami Lakes, FL 33014 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-1538-2014Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.Class IITerminated

Verification record

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