Advance Medical Designs, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 32
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2533-2023 | Class II | 50-GEL20; Ultrasound gel | July 7, 2023 |
| Z-2535-2023 | Class II | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, | July 7, 2023 |
| Z-2537-2023 | Class II | procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 2 | July 7, 2023 |
| Z-2536-2023 | Class II | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, | July 7, 2023 |
| Z-2534-2023 | Class II | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04 | July 7, 2023 |
| Z-2532-2023 | Class II | ASG-001; Ultrasound gel | July 7, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K223689 | Disposable Needle Guides and Grids | August 2, 2023 |
| K163050 | Advance Medical Designs, Inc. Sterile Ultrasound Gel | October 25, 2017 |
| K053495 | EQUIPMENT SLUSH DRAPE | March 16, 2006 |
| K011265 | ULTRASOUND TRANSDUCER COVER | October 30, 2001 |
| K012168 | ADVANCE MEDICAL DESIGNS FLUID POUCH | September 18, 2001 |
| K011422 | SURGICAL DRAPES | July 10, 2001 |
| K003670 | PATIENT DRAPE, SURGICAL | January 26, 2001 |
| K911884 | ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES | July 5, 1994 |
| K925115 | AMD DENTIST AND HYGIENIST KITS | July 5, 1994 |
| K915301 | ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK | December 11, 1992 |
| K911732 | ADVANCE DISPOSABLE CONTROL SYRINGE | September 16, 1991 |
| K904601 | ADVANCE DISPOSABLE PRESSURE TRANSDUCER | December 17, 1990 |
| K902724 | ADVANCE DISPOSABLE STOPCOCK | December 5, 1990 |
| K903358 | ADVANCE LAPAROTOMY SPONGE, LAP SPONGE | November 29, 1990 |
| K902346 | DISPOSABLE CORONARY CONTROL SYRINGE | June 26, 1990 |
| K900187 | ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH) | May 1, 1990 |
| K900188 | ADVANCE ADMINISTRATION SETS (VARYING LENGTH) | May 1, 1990 |
| K897196 | ADVANCE STOPCOCKS ADVANCE MANIFOLDS | March 27, 1990 |
| K897197 | ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. | March 19, 1990 |
| K896076 | L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R) | January 4, 1990 |