Facility

BIOREP TECHNOLOGIES, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3005593675
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	15804 NW 57th Ave Miami Lakes, FL, US 33014
Registration status	Active · expires 2026
Parent company	Biorep Technologies, Inc. (owner-operator 10035038)
Brand names	MI DeTACH Aortic Cross Clamp Head Medium; MI DeTACH Aortic Cross Clamp Delivery Device; MI DeTACH Aortic Cross Clamp Head Small; MI DeTACH Aortic Cross Clamp Delivery System Kit; MI DeTACH Aortic Cross Clamp Quick Release; MI DeTACH Aortic Cross Clamp Head Large

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Clamp, Vascular
Product code DXC (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4450

Recalls & enforcement

Class IITerminated2014-03-19
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.

FDA inspections (3)

NAI2024-04-26
No Action Indicated · Compliance: Devices
NAI2018-02-05
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2016-12-06
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Project Evaluation: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Biorep Technologies, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BIOREP TECHNOLOGIES, INC. (FEI 3005593675) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005593675-biorep-technologies-inc/

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