Advance Medical Designs, Inc.

Code	Device name	Class	Specialty	Clearances	Most recent
ITX	Transducer, Ultrasonic, Diagnostic	Class II	Radiology	1	2023-08-02

Date	Severity	Status	Recall #	Product	Code	Reason
2023-07-07	Class II	Ongoing	Z-2537-2023	procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 2…	—	Ultrasound gel mislabeled with inappropriate use.
2023-07-07	Class II	Ongoing	Z-2536-2023	Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d)…	—	Ultrasound gel mislabeled with inappropriate use.
2023-07-07	Class II	Ongoing	Z-2535-2023	Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 2…	—	Ultrasound gel mislabeled with inappropriate use.
2023-07-07	Class II	Ongoing	Z-2534-2023	Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04	—	Ultrasound gel mislabeled with inappropriate use.
2023-07-07	Class II	Ongoing	Z-2533-2023	50-GEL20; Ultrasound gel	—	Ultrasound gel mislabeled with inappropriate use.
2023-07-07	Class II	Ongoing	Z-2532-2023	ASG-001; Ultrasound gel	—	Ultrasound gel mislabeled with inappropriate use.

Date	K-number	Device	Code	Class	Specialty
2023-08-02	K223689	Disposable Needle Guides and Grids	ITX	Class II	Radiology

Clearance cadence by quarter