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Advance Medical Designs, Inc.

United States·US-MF-000009790

Last updated September 17, 2026

About

Trust Advance Medical Designs for innovative surgical infection control. High-quality products and solutions designed for superior OR patient safety.

From the manufacturer's own website. Source

Information

Country: United States
Address: 1241 Atlanta Industrial Drive, Marietta, United States
Website: www.advancemedicaldesigns.com
LinkedIn: linkedin.com/company/advance-medical-designs
Facebook: facebook.com/advancemedicaldesignsinc
Email: [email protected]
Phone: 1 (770) 422 3125
PRRC Contact: David Mackie
EUDAMED SRN: US-MF-000009790
FDA FEI Number: 1037885
DUNS Number: —

Catalogue (871)

Page 1 of 18

Device	Model / Reference	Registries	Class	Status
Unbranded	07-PK804	FDA UDI	Class II	Active
Unbranded	P3D696NG	FDA UDI	Class II	Active
Unbranded	02-5030TL	FDA UDI	Class II	Active
Unbranded	PK805NS	FDA UDI	Class II	Active
Unbranded	09-MK920	FDA UDI	Class II	Active
Unbranded	5225315	FDA UDI	Class II	Active
CO2 Tank Cover	CO2548NS	FDA UDI	Class II	Active
Unbranded	09-MK905	FDA UDI	Class II	Active
Snap Kover	08-CC162	FDA UDI	Class II	Active
Unbranded	KP09LNS	FDA UDI	Class II	Active
Unbranded	20-PMT03	FDA UDI	Class II	Active
Unbranded	CD03NS	FDA UDI	Class II	Active
Unbranded	25-FF436	FDA UDI	Class II	Active
Soft Flex Probe Cover	20-PC824	FDA UDI	Class II	Active
Ultrasound Probe Cover Biopsy Needle Guide Kit	28-EG163	FDA UDI	Class II	Active
Unbranded	02-3654TL	FDA UDI	Class II	Active
Urological Drainage Bag	CC166NS	FDA UDI	Class II	Active
Unbranded	20-P3D696	FDA UDI	Class II	Active
Unbranded	60-HP10R	FDA UDI	Class II	Active
Ultrasound Probe Cover Biopsy Needle Guide Kit	28-GG515	FDA UDI	Class II	Active
Tubular Cover	08-CC29	FDA UDI	Class II	Active
Unbranded	04-CC800	FDA UDI	Class II	Active
Ultrasound Probe Cover Biopsy Needle Guide Kit	28-GG531	FDA UDI	Class II	Active
Ultrasound Probe Cover Biopsy Needle Guide	28-GG107	FDA UDI	Class II	Active
Unbranded	01-3020	FDA UDI	Class II	Active
Unbranded	71604	FDA UDI	Class II	Active
Unbranded	O-UC32	FDA UDI	Class II	Active
Unbranded	02-2840TL	FDA UDI	Class II	Active
Unbranded	06-LKAV1	FDA UDI	Class II	Active
Unbranded	06-CLK05	FDA UDI	Class II	Active
Unbranded	5005NS	FDA UDI	Class II	Active
Unbranded	2019	FDA UDI	U	Active
Urological Drainage Bag	CC164NST	FDA UDI	Class II	Active
Unbranded	CA601NS	FDA UDI	Class II	Active
Ultrasound Probe Cover Biopsy Needle Guide Kit	28-GG305	FDA UDI	Class II	Active
Unbranded	06-LK801	FDA UDI	Class II	Active
Unbranded	CC501NS	FDA UDI	Class II	Active
Custom Drape w/o Rubber Bands	08-CC148	FDA UDI	Class II	Active
Unbranded	02-2812TL	FDA UDI	Class II	Active
Unbranded	06-CLK03	FDA UDI	Class II	Active
Unbranded	JA-5313NS	FDA UDI	Class II	Active
Unbranded	02-0512PT	FDA UDI	Class II	Active
Unbranded	02-3628TL	FDA UDI	Class II	Active
Ultrasound Probe Cover Biopsy Needle Guide	28-EG508	FDA UDI	Class II	Active
Unbranded	5470CNS	FDA UDI	Class II	Active
Unbranded	20-P3D424	FDA UDI	Class II	Active
Unbranded	07-CA104	FDA UDI	Class II	Active
Unbranded	3620-04NS	FDA UDI	Class II	Active
Unbranded	65-CMS04	FDA UDI	Class II	Active
Miniview 6800 C-Arm Drape	5261633	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (7)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 7, 2023	Z-2532-2023	—	open, classified	Ultrasound gel mislabeled with inappropriate use.
Jul 7, 2023	Z-2537-2023	—	open, classified	Ultrasound gel mislabeled with inappropriate use.
Jul 7, 2023	Z-2536-2023	—	open, classified	Ultrasound gel mislabeled with inappropriate use.
Jul 7, 2023	Z-2533-2023	—	open, classified	Ultrasound gel mislabeled with inappropriate use.
Jul 7, 2023	Z-2535-2023	—	open, classified	Ultrasound gel mislabeled with inappropriate use.
Jul 7, 2023	Z-2534-2023	—	open, classified	Ultrasound gel mislabeled with inappropriate use.
Jun 18, 2004	Z-1036-04	—	terminated	The product may come apart when excessive force is applied to the coupler.