Company ยท US
Advance Medical Designs, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2023. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 5 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 4 |
| ITX | Transducer, Ultrasonic, Diagnostic | 4 |
| KPE | Container, I.V. | 3 |
| MUI | Media, Coupling, Ultrasound | 3 |
| DRC | Trocar | 2 |
| FMF | Syringe, Piston | 2 |
| FPA | Set, Administration, Intravascular | 2 |
| GDF | Guide, Needle, Surgical | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| EKJ | Burnisher, Operative | 1 |
| FMG | Stopcock, I.V. Set | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 |
| IZI | System, X-Ray, Angiographic | 1 |
| KNW | Instrument, Biopsy | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 |
| LZC | Medical Glove, Specialty | 1 |
| NAD | Dressing, Wound, Occlusive | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 2, 2023 | K223689 | Disposable Needle Guides and Grids Advance Medical Designs, Inc. | ITX |
| Oct 25, 2017 | K163050 | Advance Medical Designs, Inc. Sterile Ultrasound Gel Advance Medical Designs, Inc. | MUI |
| Mar 16, 2006 | K053495 | EQUIPMENT SLUSH DRAPE Advance Medical Designs, Inc. | KKX |
| Oct 30, 2001 | K011265 | ULTRASOUND TRANSDUCER COVER Advance Medical Designs, Inc. | ITX |
| Sep 18, 2001 | K012168 | ADVANCE MEDICAL DESIGNS FLUID POUCH Advance Medical Designs, Inc. | KKX |
| Jul 10, 2001 | K011422 | SURGICAL DRAPES Advance Medical Designs, Inc. | KKX |
| Jan 26, 2001 | K003670 | PATIENT DRAPE, SURGICAL Advance Medical Designs, Inc. | KKX |
| Jul 5, 1994 | K925115 | AMD DENTIST AND HYGIENIST KITS Advance Medical Designs, Inc. | EKJ |
| Jul 5, 1994 | K911884 | ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES Advance Medical Designs, Inc. | DTL |
| Dec 11, 1992 | K915301 | ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK Advance Medical Designs, Inc. | DTL |
| Sep 16, 1991 | K911732 | ADVANCE DISPOSABLE CONTROL SYRINGE Advance Medical Designs, Inc. | IZI |
| Dec 17, 1990 | K904601 | ADVANCE DISPOSABLE PRESSURE TRANSDUCER Advance Medical Designs, Inc. | DRS |
| Dec 5, 1990 | K902724 | ADVANCE DISPOSABLE STOPCOCK Advance Medical Designs, Inc. | FMG |
| Nov 29, 1990 | K903358 | ADVANCE LAPAROTOMY SPONGE, LAP SPONGE Advance Medical Designs, Inc. | GDY |
| Jun 26, 1990 | K902346 | DISPOSABLE CORONARY CONTROL SYRINGE Advance Medical Designs, Inc. | FMF |
| May 1, 1990 | K900188 | ADVANCE ADMINISTRATION SETS (VARYING LENGTH) Advance Medical Designs, Inc. | FPA |
| May 1, 1990 | K900187 | ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH) Advance Medical Designs, Inc. | FPA |
| Mar 27, 1990 | K897196 | ADVANCE STOPCOCKS ADVANCE MANIFOLDS Advance Medical Designs, Inc. | DTL |
| Mar 19, 1990 | K897197 | ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. Advance Medical Designs, Inc. | DTL |
| Jan 4, 1990 | K896076 | L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R) Advance Medical Designs, Inc. | LZC |
| Nov 14, 1989 | K895455 | SELDINGER PERCUTANEOUS 2 PC NEEDLES Advance Medical Designs, Inc. | DRC |
| Nov 14, 1989 | K895454 | SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK) Advance Medical Designs, Inc. | DRC |
| Nov 1, 1989 | K895845 | 2018 ARTERIAL/VENOUS PRESSURE DRESSING Advance Medical Designs, Inc. | NAD |
| Nov 1, 1989 | K895457 | MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES Advance Medical Designs, Inc. | KNW |
| Oct 19, 1989 | K895453 | SPINAL NEEDLE Advance Medical Designs, Inc. | BSP |
| Sep 19, 1989 | K894801 | 30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES Advance Medical Designs, Inc. | FMF |
| Aug 18, 1989 | K894764 | OR TOWEL PACKS Advance Medical Designs, Inc. | KKX |
| Sep 20, 1985 | K852893 | VIAL DECANTER Advance Medical Designs, Inc. | KPE |
| Aug 21, 1985 | K853188 | TRANSFER DEVICE Advance Medical Designs, Inc. | LHI |
| Aug 16, 1985 | K852778 | BOTTLE DECANTER Advance Medical Designs, Inc. | KPE |
| Aug 16, 1985 | K852777 | BAG DECANTER Advance Medical Designs, Inc. | KPE |
| Apr 9, 1985 | K850959 | EQUIPMENT SNAP KOVERS Advance Medical Designs, Inc. | JAA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2023 | Advance Medical Designs, Inc. 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) Open, Classified |
GDF | None listed |
| Sep 9, 2023 | Advance Medical Designs, Inc. 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 Open, Classified |
GDF | None listed |
| Sep 9, 2023 | Advance Medical Designs, Inc. Procedural kits containing ultrasonic transmission gel, Item Numbers:
a) 20-PC424,
b) 20-PC448,
c) 20-PC548,
d) 20-PC596,
e) 20-PC648 Open, Classified |
ITX | None listed |
| Sep 9, 2023 | Advance Medical Designs, Inc. Procedural kits containing ultrasonic transmission gel, Item Numbers:
a) 20-PMT03, b) 20PMT04 Open, Classified |
ITX | None listed |
| Sep 9, 2023 | Advance Medical Designs, Inc. 50-GEL20; Ultrasound gel Open, Classified |
MUI | K130581 |
| Sep 9, 2023 | Advance Medical Designs, Inc. ASG-001; Ultrasound gel Open, Classified |
MUI | K130581 |
| Jul 20, 2004 | Advance Medical Designs Inc Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, Terminated |
JAA | K850959 |