Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1037885

FEI Number

1037885

Entity Name

ADVANCE MEDICAL DESIGNS, INC.

City/State/Country

MARIETTA, GA, US

Establishment Address

1241 Atlanta Industrial Dr, MARIETTA, GA 30066, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

ADVANCE MEDICAL DESIGNS, INC. (Owner Number: 1037885)

Owner / Operator Contact Address

1241 ATLANTA INDUSTRIAL DR., --, Marietta, GA 30066, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arterial/ Venous Pressure Dressing Control Syringes Microscope Knob Cover Arterial Needles Safety Straps Ankle Straps Finger Traps Arm Sleeve for use with Shoulder Suspension System Lateral Traction Sling for use with Shoulder Suspension System Fluid Delivery Sets Spinal Needle Hominis® Sterile Drape for Robotic Control Unit, TOP Model 6N Hominis® Sterile Drape for Robotic Control Unit, BOTTOM Model 6N Equipment Kovers OR Table Accessories TROCAR Patient Drape Madayag, Manghini, Franseen Trocar Digital Robotic Microscope Sterile Drape Angiographic Waste Bag Advance Medical Designs Ultrasound Gel Control Syringe Disposable Coronary Control Syringe Patient Drape Leg Cover Advance Pressure Monitoring, High P GEL POSITIONERS Head Rest Restraint Transfer Device DRAPE Bag Decanter Vial Decanter Advance Pressure Monitor/ High Pres Advance Disposable Control Syringe Advance Medical Designs Fluid Pouch ESMARK BANDAGE Cohesive Bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2007-10-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-10-09
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	2007-10-09
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2007-10-09
NZD	Stretcher, Patient Restraint	General Hospital	Class 1	880.6900	2019-04-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-10-09
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2007-10-09
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2007-10-09
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2006-06-20
DRC	Trocar	Cardiovascular	Class 2	870.1390	2006-04-20
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2007-10-09
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2007-10-09
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2021-06-29
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2019-08-28
MUI	Media, Coupling, Ultrasound	Radiology	Class 2	892.1570	2017-10-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-10-09
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2007-10-09
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2013-05-20
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2007-10-09
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2007-06-27
IRS	Head Halter, Traction	Physical Medicine	Class 1	890.5925	2013-05-21
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2007-10-09
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2002-02-28
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2007-10-09
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2007-10-09
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2007-10-09
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2007-10-09
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2007-10-09
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-01-05

Official Correspondent

ANTHONY COTTONE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ADVANCE MEDICAL DESIGNS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1037885. Last updated year: 2026. Please use registration number 1037885 when referencing this establishment in official correspondence.