Advance Medical Designs Inc
Marietta, GA, US
ADVANCE MEDICAL DESIGNS, INC. appears in FDA device records in Marietta, GA. FDA records list 32 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 32 510(k) clearances for Advance Medical Designs Inc between 1985 and 2023. The busiest year on record is 1990, with 9. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 5 |
| 1989 | 7 |
| 1990 | 9 |
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 2 |
| 2001 | 4 |
| 2006 | 1 |
| 2017 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223689 | Disposable Needle Guides and Grids | ITX | Substantially Equivalent | |
| K163050 | Advance Medical Designs, Inc. Sterile Ultrasound Gel | MUI | Substantially Equivalent | |
| K053495 | EQUIPMENT SLUSH DRAPE | KKX | Substantially Equivalent | |
| K011265 | ULTRASOUND TRANSDUCER COVER | ITX | Substantially Equivalent | |
| K012168 | ADVANCE MEDICAL DESIGNS FLUID POUCH | KKX | Substantially Equivalent | |
| K011422 | SURGICAL DRAPES | KKX | Substantially Equivalent | |
| K003670 | PATIENT DRAPE, SURGICAL | KKX | Substantially Equivalent | |
| K925115 | AMD DENTIST AND HYGIENIST KITS | EKJ | Substantially Equivalent | |
| K911884 | ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES | DTL | Substantially Equivalent | |
| K915301 | ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK | DTL | Substantially Equivalent | |
| K911732 | ADVANCE DISPOSABLE CONTROL SYRINGE | IZI | Substantially Equivalent | |
| K904601 | ADVANCE DISPOSABLE PRESSURE TRANSDUCER | DRS | Substantially Equivalent | |
| K902724 | ADVANCE DISPOSABLE STOPCOCK | FMG | Substantially Equivalent | |
| K903358 | ADVANCE LAPAROTOMY SPONGE, LAP SPONGE | GDY | Substantially Equivalent | |
| K902346 | DISPOSABLE CORONARY CONTROL SYRINGE | FMF | Substantially Equivalent | |
| K900188 | ADVANCE ADMINISTRATION SETS (VARYING LENGTH) | FPA | Substantially Equivalent | |
| K900187 | ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH) | FPA | Substantially Equivalent | |
| K897196 | ADVANCE STOPCOCKS ADVANCE MANIFOLDS | DTL | Substantially Equivalent | |
| K897197 | ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. | DTL | Substantially Equivalent | |
| K896076 | L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R) | LZC | Substantially Equivalent | |
| K895455 | SELDINGER PERCUTANEOUS 2 PC NEEDLES | DRC | Substantially Equivalent | |
| K895454 | SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK) | DRC | Substantially Equivalent | |
| K895845 | 2018 ARTERIAL/VENOUS PRESSURE DRESSING | NAD | Substantially Equivalent | |
| K895457 | MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES | KNW | Substantially Equivalent | |
| K895453 | SPINAL NEEDLE | BSP | Substantially Equivalent | |
| K894801 | 30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES | FMF | Substantially Equivalent | |
| K894764 | OR TOWEL PACKS | KKX | Substantially Equivalent | |
| K852893 | VIAL DECANTER | KPE | Substantially Equivalent | |
| K853188 | TRANSFER DEVICE | LHI | Substantially Equivalent | |
| K852778 | BOTTLE DECANTER | KPE | Substantially Equivalent | |
| K852777 | BAG DECANTER | KPE | Substantially Equivalent | |
| K850959 | EQUIPMENT SNAP KOVERS | JAA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1037885 | 1037885 | ADVANCE MEDICAL DESIGNS, INC. | 1241 Atlanta Industrial Dr, MARIETTA, GA 30066 US | 2026 | and 15 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- FQMBandage, Elastic
- KMEBedding, Disposable, Medical
- EKJBurnisher, Operative
- KPEContainer, I.V.
- NNIContainer, Specimen, Non-Sterile
- IPMCover, Limb
- KKXDrape, Surgical, Antimicrobial
- PUIDrape, Surgical, Exempt
- NADDressing, Wound, Occlusive
- GDYGauze/Sponge, Internal, X-Ray Detectable
- GDFGuide, Needle, Surgical
- IRSHead Halter, Traction
- KNWInstrument, Biopsy
- MUIMedia, Coupling, Ultrasound
- LZCMedical Glove, Specialty
- HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FWZOperating Room Accessories Table Tray
- FMPProtector, Skin Pressure
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- FMGStopcock, I.V. Set
- NZDStretcher, Patient Restraint
- FMFSyringe, Piston
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- DRSTransducer, Blood-Pressure, Extravascular
- ITXTransducer, Ultrasonic, Diagnostic
- DRCTrocar
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 | Ultrasound gel mislabeled with inappropriate use. | Class II | Open, Classified | |
| 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 | Ultrasound gel mislabeled with inappropriate use. | Class II | Open, Classified | |
| 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 | Ultrasound gel mislabeled with inappropriate use. | Class II | Open, Classified | |
| Z-2534-2023 | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04 | Ultrasound gel mislabeled with inappropriate use. | Class II | Open, Classified | |
| Z-2533-2023 | 50-GEL20; Ultrasound gel | Ultrasound gel mislabeled with inappropriate use. | Class II | Open, Classified | |
| Z-2532-2023 | ASG-001; Ultrasound gel | Ultrasound gel mislabeled with inappropriate use. | Class II | Open, Classified | |
| Z-1036-04 | 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, GA 80066 USA. | The product may come apart when excessive force is applied to the coupler. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain