Advance Medical Designs, Inc.
Advance Medical Designs, Inc. holds FDA 510(k) medical device clearances, first cleared 1985, most recent 2023, with 6 FDA device recalls on record.
Top product codes for Advance Medical Designs, Inc.
FDA recalls by Advance Medical Designs, Inc.
- Z-2535-2023 — Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
- Z-2534-2023 — Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
- Z-2537-2023 — procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿¿¿ 28-GG023, b)¿¿¿¿ 28-GG105, c)¿¿¿¿¿ 28-GG107, d)¿¿¿¿ 28-GG121, e)¿¿¿¿ 28-GG219, f)¿¿¿¿¿¿ 28-GG223, g)¿¿¿¿¿ 28-GG303, h)¿¿¿¿ 28-GG307, i)¿¿¿¿¿¿ 28-GG519, j)¿¿¿¿¿¿ 28-GG519PC, k)¿¿¿¿¿ 28-GG521, l)¿¿¿¿¿¿ 28-GG521PC, m)¿¿¿ 28-GG529, n)¿¿¿¿ 28-GG553, o)¿¿¿¿ 28-GG569, p)¿¿¿¿ 28-GG571, q)¿¿¿¿ 28-GG723
- Z-2533-2023 — 50-GEL20; Ultrasound gel
- Z-2536-2023 — Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
- Z-2532-2023 — ASG-001; Ultrasound gel
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Advance Medical Designs, Inc.
- K223689 — Disposable Needle Guides and Grids
- K163050 — Advance Medical Designs, Inc. Sterile Ultrasound Gel
- K053495 — EQUIPMENT SLUSH DRAPE
- K011265 — ULTRASOUND TRANSDUCER COVER
- K012168 — ADVANCE MEDICAL DESIGNS FLUID POUCH
- K011422 — SURGICAL DRAPES
- K003670 — PATIENT DRAPE, SURGICAL
- K911884 — ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES
- K925115 — AMD DENTIST AND HYGIENIST KITS
- K915301 — ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK
- K911732 — ADVANCE DISPOSABLE CONTROL SYRINGE
- K904601 — ADVANCE DISPOSABLE PRESSURE TRANSDUCER
- K902724 — ADVANCE DISPOSABLE STOPCOCK
- K903358 — ADVANCE LAPAROTOMY SPONGE, LAP SPONGE
- K902346 — DISPOSABLE CORONARY CONTROL SYRINGE
- K900187 — ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)
- K900188 — ADVANCE ADMINISTRATION SETS (VARYING LENGTH)
- K897196 — ADVANCE STOPCOCKS ADVANCE MANIFOLDS
- K897197 — ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.
- K896076 — L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R)
- K895454 — SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)
- K895455 — SELDINGER PERCUTANEOUS 2 PC NEEDLES
- K895457 — MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES
- K895845 — 2018 ARTERIAL/VENOUS PRESSURE DRESSING
- K895453 — SPINAL NEEDLE
- K894801 — 30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES
- K894764 — OR TOWEL PACKS
- K852893 — VIAL DECANTER
- K853188 — TRANSFER DEVICE
- K852777 — BAG DECANTER
- K852778 — BOTTLE DECANTER
- K850959 — EQUIPMENT SNAP KOVERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.