Facility

Augmedics Ltd.

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3016571711
Establishment type	Manufacture Medical Device
Location	2 Ha-Otsma St Yokneam Illit Northern, IL 20692
Registration status	Active · expires 2026
Parent company	Augmedics Ltd. (owner-operator 10062650)
Brand names	XVision Spine System (XVS)

Activity by year

Recalls (1)

Devices registered here (1)

Orthopedic Augmented Reality
Product code SBF (opens in a new tab) · Class II · Neurology · 21 CFR 882.4560

Recalls & enforcement

Class IIOngoing2025-04-14
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.

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. “Augmedics Ltd. (FEI 3016571711) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3016571711-augmedics-ltd/

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