Facility

ELUCENT MEDICAL INC.

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

Key facts

1recalls · worst Class II

2inspections · worst NAI

—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)	3014653199
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	6509 Flying Cloud Drive Eden Prairie, MN, US 55344
Registration status	Active · expires 2026
Parent company	Elucent Medical Inc. (owner-operator 10057977)
Brand names	EnVisio System; SmartSensor

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Marker, Radiographic, Implantable
Product code NEU (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4300

Recalls & enforcement

Class IIOngoing2024-11-18
There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when used with the EnVisio Navigation System.

FDA inspections (2)

NAI2024-11-19
No Action Indicated · Compliance: Devices
NAI2022-02-11
No Action Indicated · Compliance: Devices

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 Elucent Medical 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. “ELUCENT MEDICAL INC. (FEI 3014653199) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014653199-elucent-medical-inc/

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