ADVANCE MEDICAL DESIGNS, INC.

Registration Details

Registration Name: ADVANCE MEDICAL DESIGNS, INC.
Registration Number: 1037885
FEI Number: 1037885
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 1241 Atlanta Industrial Dr
City: MARIETTA
State: GA
ZIP: 30066
Country: US

Regulatory Submissions

510(k) Number: K895845

Owner / Operator

Firm Name: ADVANCE MEDICAL DESIGNS, INC.
Operator Number: 1037885
Address: 1241 ATLANTA INDUSTRIAL DR., --
City: Marietta
State: GA
Postal Code: 30066
Country: US
Correspondent: ANTHONY - COTTONE

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Dressing, Wound, Occlusive	NAD	Class 1	General, Plastic Surgery	No	2007-10-09
Syringe, Piston	FMF	Class 2	General Hospital	No	2007-10-09
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	HRM	Class 1	General, Plastic Surgery	No	2007-10-09
Instrument, Biopsy	KNW	Class 2	Gastroenterology, Urology	No	2007-10-09
Stretcher, Patient Restraint	NZD	Class 1	General Hospital	No	2019-04-24
Set, Administration, Intravascular	FPA	Class 2	General Hospital	No	2007-10-09
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	Class 2	Anesthesiology	No	2007-10-09
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	Class 2	Radiology	No	2007-10-09
Operating Room Accessories Table Tray	FWZ	Class 1	General, Plastic Surgery	No	2006-06-20
Trocar	DRC	Class 2	Cardiovascular	No	2006-04-20
Drape, Surgical, Antimicrobial	KKX	Class 2	General, Plastic Surgery	No	2007-10-09
Drape, Surgical, Exempt	PUI	Class 2	General, Plastic Surgery	No	2021-06-29
Container, Specimen, Non-Sterile	NNI	Class 1	Pathology	No	2019-08-28
Media, Coupling, Ultrasound	MUI	Class 2	Radiology	No	2017-10-25
Cover, Limb	IPM	Class 1	Physical Medicine	No	2013-05-20
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	Class 2	Cardiovascular	No	2007-10-09
Protector, Skin Pressure	FMP	Class 1	General Hospital	No	2007-06-27
Head Halter, Traction	IRS	Class 1	Physical Medicine	No	2013-05-21
Set, I.V. Fluid Transfer	LHI	Class 2	General Hospital	No	2007-10-09
Container, I.V.	KPE	Class 2	General Hospital	No	2007-10-09
System, X-Ray, Angiographic	IZI	Class 2	Radiology	No	2007-10-09
Bandage, Elastic	FQM	Class 1	General Hospital	No	2006-01-05
Bedding, Disposable, Medical	KME	Class 1	General Hospital	No	2004-09-01
Transducer, Ultrasonic, Diagnostic	ITX	Class 2	Radiology	No	2023-10-04
Guide, Needle, Surgical	GDF	Class 1	General, Plastic Surgery	No	2021-06-29

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 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 Bottle Decanter PART 90-ART07 O.R. TABLE SHEET Decanter Needle Guides and Grids Ultrasound Transducer Cover

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198