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Data / Medical devices / United States / Advance Medical Designs, Inc.

Advance Medical Designs, Inc.: FDA-registered device maker in Marietta, GA, United States, 23 510(k) clearances

Advance Medical Designs, Inc. is registered with the FDA (registration 1037885) in Marietta, GA, United States. It lists 25 device types. The FDA files 23 510(k) clearances under its listings, the newest dated August 2, 2023. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Advance Medical Designs, Inc.
FDA registration number
1037885
Address
1241 Atlanta Industrial Dr, Marietta, GA, United States, 30066
Owner or operator
ADVANCE MEDICAL DESIGNS, INC. (1037885)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
February 28, 2002
Registered through
2027
Brand names listed
Advance Disposable Control Syringe, Advance Medical Designs Fluid Pouch, Advance Medical Designs Ultrasound Gel, Advance Pressure Monitor/ High Pres, Advance Pressure Monitoring, High P, Angiographic Waste Bag, Ankle Straps, Arm Sleeve for use with Shoulder Suspension System and more

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bandage, ElasticFQM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Repackager or relabeleraccessdata.fda.gov
Container, I.V.KPE2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Container, Specimen, Non-SterileNNI1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Cover, LimbIPM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Guide, Needle, SurgicalGDF1Complaint file establishment, Manufacturer, Specification developeraccessdata.fda.gov
Head Halter, TractionIRS1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, BiopsyKNW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Media, Coupling, UltrasoundMUI2Manufactureraccessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, OphthalmicHRM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Operating Room Accessories Table TrayFWZ1Manufactureraccessdata.fda.gov
Protector, Skin PressureFMP1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Set, Administration, IntravascularFPA2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Set, I.V. Fluid TransferLHI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Stretcher, Patient RestraintNZD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Syringe, PistonFMF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, X-Ray, AngiographicIZI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
TrocarDRC2Manufacturer, Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 2, 2023K223689Disposable Needle Guides and GridsITXSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
October 25, 2017K163050Advance Medical Designs, Inc. Sterile Ultrasound GelMUISubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
March 16, 2006K053495EQUIPMENT SLUSH DRAPEKKXSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
October 30, 2001K011265ULTRASOUND TRANSDUCER COVERITXSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
September 18, 2001K012168ADVANCE MEDICAL DESIGNS FLUID POUCHKKXSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
July 10, 2001K011422SURGICAL DRAPESKKXSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
January 26, 2001K003670PATIENT DRAPE, SURGICALKKXSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
July 5, 1994K911884ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINESDTLSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
September 16, 1991K911732ADVANCE DISPOSABLE CONTROL SYRINGEIZISubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
June 26, 1990K902346DISPOSABLE CORONARY CONTROL SYRINGEFMFSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
May 1, 1990K900187ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)FPASubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
March 19, 1990K897197ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.DTLSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
November 14, 1989K895454SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)DRCSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
November 1, 1989K8958452018 ARTERIAL/VENOUS PRESSURE DRESSINGNADSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
November 1, 1989K895457MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLESKNWSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
October 19, 1989K895453SPINAL NEEDLEBSPSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
September 19, 1989K89480130-CS01, 30-CS02, 30-CS03 CONTROL SYRINGESFMFSubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
April 11, 1989K891001MICROSCOPE KNOB COVER, STERILE, DISPOSABLEHRMSubstantially EquivalentPrescott'S, Inc.accessdata.fda.gov
September 20, 1985K852893VIAL DECANTERKPESubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
August 21, 1985K853188TRANSFER DEVICELHISubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
August 16, 1985K852778BOTTLE DECANTERKPESubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
August 16, 1985K852777BAG DECANTERKPESubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov
April 9, 1985K850959EQUIPMENT SNAP KOVERSJAASubstantially EquivalentAdvance Medical Designs, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
July 7, 202392735Class IIOngoingASG-001; Ultrasound gelUltrasound gel mislabeled with inappropriate use.accessdata.fda.gov
June 18, 200429375Not yet classifiedTerminatedAdvance 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.accessdata.fda.gov

Compare with other makers

Updated September 9, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.