Facility

ADVANCE MEDICAL DESIGNS, 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)	1037885
Establishment type	Repack or Relabel Medical Device; Manufacture Medical Device
Location	1241 Atlanta Industrial Dr MARIETTA, GA, US 30066
Registration status	Active · expires 2026
Parent company	ADVANCE MEDICAL DESIGNS, INC. (owner-operator 1037885)
Brand names	Advance Medical Designs Fluid Pouch

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Drape, Surgical, Antimicrobial
Product code KKX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4370

Recalls & enforcement

Class IIOngoing2023-07-07
Ultrasound gel mislabeled with inappropriate use.

FDA inspections (3)

NAI2023-06-30
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-07-26
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2016-12-15
No Action Indicated · Compliance: Devices; Postmarket Assurance: 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 ADVANCE MEDICAL DESIGNS, 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. “ADVANCE MEDICAL DESIGNS, INC. (FEI 1037885) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1037885-advance-medical-designs-inc/

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