Facility

CLARUS MEDICAL, LLC.

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)	1000116142
Establishment type	Manufacture Medical Device
Location	13355 10th Ave N Ste 110 Minneapolis, MN, US 55441
Registration status	Active · expires 2026
Parent company	CLARUS MEDICAL, LLC. (owner-operator 9000372)
Brand names	Model CB2-200 Video Inspection Scope; Model C1-800 Clarus Inspection Scope; Model CD-USB Control Box; Model CD-HDMI Control Box; Model CD-1100 Video Inspection Scope; Model CB2-110 Video Inspection Scope; Model C2-950 Clarus Inspection Scope; Model CB2-60 Video Inspection Scope; Model CB1-110 Video Inspection Scope; Model C2-350 Clarus Inspection Scope; Model CB1-110HD Clarus Digital Inspection Scope, High Definition

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Accessories, Cleaning Brushes, For Endoscope
Product code MNL (opens in a new tab) · Class I · Gastroenterology, Urology · 21 CFR 876.1500

Recalls & enforcement

Class IITerminated2021-07-27
The sterile barrier seal may be compromised.

FDA inspections (3)

NAI2025-05-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2021-03-10
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-08-23
No Action Indicated · Compliance: Devices; Postmarket Assurance: 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 CLARUS MEDICAL, LLC.

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. “CLARUS MEDICAL, LLC. (FEI 1000116142) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000116142-clarus-medical-llc/

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