Facility

KOVEN TECHNOLOGY, INC.

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

Key facts

1recalls · worst Class II

3inspections · worst OAI

1warning letters

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

FDA Establishment Identifier (FEI)	1937397
Establishment type	Repack or Relabel Medical Device
Location	625 Maryville Centre Dr Ste 300 Saint Louis, MO, US 63141
Registration status	Active · expires 2026
Parent company	KOVEN TECHNOLOGY, INC. (owner-operator 1937397)
Brand names	ES100X

Activity by year

Recalls (1)
Inspections (3)
Warning letters (1)

Devices registered here (1)

Transducer, Ultrasonic
Product code JOP (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2880

Recalls & enforcement

Class IIOngoing2026-03-04
Product labeling includes a fetal indication for use that is not cleared under its 510(k).

FDA inspections (3)

OAI2026-02-06
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2022-11-15
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2017-11-03
Voluntary 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.

FDA warning letters (1)

Warning Letter2026-07-21
Warning Letter (opens in a new tab) · Saint Louis Missouri

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by KOVEN TECHNOLOGY, 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. “KOVEN TECHNOLOGY, INC. (FEI 1937397) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1937397-koven-technology-inc/

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