Data / Medical devices / United States / Medas, Inc.

Medas, Inc.: FDA-registered device maker in Miami, FL, United States, 38 510(k) clearances

Name: Medas, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medas, Inc. is registered with the FDA (registration 3012050423) in Miami, FL, United States. It lists 40 device types. The FDA files 38 510(k) clearances under its listings, the newest dated May 16, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012050423
Address: 20855 NE 16TH Avenue C21, Miami, FL, United States, 33179
Owner or operator: Medas, Inc. (10053534)
Roles: Repackager or relabeler
First device listed: January 16, 2017
Registered through: 2026
Brand names listed: Endotracheal Tube with Cuff, all sizes, Intravascular Administration Set, Intravascular Catheter, Latex Patient Glove, MEDADV ARTERIAL EMBOLECTOMY CATHETER, MEDADV Anesthetic Gas Mask, MEDADV BLOW INFLATION DEVICE, MEDADV BORER GUIDE WIRE and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Repackager or relabeler	accessdata.fda.gov
Airway, Nasopharyngeal	BTQ	1	Repackager or relabeler	accessdata.fda.gov
Appliance, Colostomy, Disposable	EZS	1	Repackager or relabeler	accessdata.fda.gov
Bag, Drainage, With Adhesive, Ostomy	FON	1	Repackager or relabeler	accessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Sterile	FAQ	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Embolectomy	DXE	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Hemodialysis, Implanted	MSD	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Hemodialysis, Non-Implanted	MPB	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Retention Type, Balloon	EZL	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Ureteral, Gastro-Urology	EYB	2	Repackager or relabeler	accessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, Percutaneous	LOX	2	Repackager or relabeler	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Vascular	DXC	2	Repackager or relabeler	accessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling Catheter	KNX	2	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Repackager or relabeler	accessdata.fda.gov
Introducer, Catheter	DYB	2	Repackager or relabeler	accessdata.fda.gov
Latex Patient Examination Glove	LYY	1	Repackager or relabeler	accessdata.fda.gov
Mask, Gas, Anesthetic	BSJ	1	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen	BYG	1	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen, Low Concentration, Venturi	BYF	1	Repackager or relabeler	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Repackager or relabeler	accessdata.fda.gov
Polymer Patient Examination Glove	LZA	1	Repackager or relabeler	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Repackager or relabeler	accessdata.fda.gov
Staple, Implantable	GDW	2	Repackager or relabeler	accessdata.fda.gov
Stapler, Surgical	GAG	2	Repackager or relabeler	accessdata.fda.gov
Stent, Ureteral	FAD	2	Repackager or relabeler	accessdata.fda.gov
Surgeon'S Gloves	KGO	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Antistick	MEG	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Balloon Inflation, Exempt	PTM	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Repackager or relabeler	accessdata.fda.gov
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	CBI	2	Repackager or relabeler	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Repackager or relabeler	accessdata.fda.gov
Wire, Guide, Catheter, Exempt	PTL	2	Repackager or relabeler	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 16, 2025	K241581	Hemodialysis Catheter	MSD	Unknown	Haolang Medical USA Corporation	accessdata.fda.gov
July 2, 2021	K211393	Selethru(TM) NC PTCA Balloon Dilatation Catheter	LOX	Substantially Equivalent	Kossel Medtech (Suzhou) Co., Ltd.	accessdata.fda.gov
December 14, 2018	K180797	Xcess Guiding Catheter	DQY	Substantially Equivalent	Curatia Medical Co.	accessdata.fda.gov
March 2, 2018	K172331	Type I, Type II, Type III, Type IV	DYB	Unknown	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
October 5, 2017	K172099	Shoocin Introducer Kit	DYB	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
July 19, 2017	K171290	Vela RX PTA Balloon Dilatation Catheter	LIT	Substantially Equivalent	Curatia Medical	accessdata.fda.gov
June 18, 2015	K142797	I.V. Catheter	FOZ	Substantially Equivalent	Jiangxi Sanxin Medtec Co., Ltd.	accessdata.fda.gov
January 30, 2015	K141354	NAVAJO PTA BALLOON DILATATION CATHETER	DQY	Substantially Equivalent	Curative Medical, Inc.	accessdata.fda.gov
January 21, 2015	K141707	ULTRASKIN HYDROPHILIC GUIDE WIRE	DQX	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
December 15, 2014	K140667	WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER	EZL	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
November 25, 2014	K140768	TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT	DYB	Substantially Equivalent	Lepu Medical Technology (Bejing) Co., Ltd.	accessdata.fda.gov
October 23, 2014	K142359	Vasc Band hemostat	DXC	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
June 4, 2014	K123126	MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)	KGO	Substantially Equivalent	Shanghai Motex Healthcare Co., Ltd.	accessdata.fda.gov
May 21, 2014	K132802	MOTEX POWDERED NITRILE SURGICAL GLOVES	KGO	Substantially Equivalent	Shanghai Motex Healthcare Co., Ltd.	accessdata.fda.gov
February 3, 2014	K123475	SHOOCIN INTRODUCER KIT	DYB	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
November 20, 2013	K130212	SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE	FMI	Substantially Equivalent	Wuxi Yushou Medical Applicances Co., Ltd.	accessdata.fda.gov
October 3, 2013	K122557	MOTEX POWDER-FREE NITRILE SURGICAL GLOVES	KGO	Substantially Equivalent	Shanghai Motex Healthcare Co., Ltd.	accessdata.fda.gov
August 13, 2013	K123473	HOPER PTCA BALLOON CATHETER	LOX	Substantially Equivalent	Lepu Medical Technology (Beijing) Co., Ltd.	accessdata.fda.gov
June 11, 2013	K131303	DISPOSABLE CIRCULAR STAPLER	GDW	Substantially Equivalent	Changzhou City Zhiye Medical Devices Institute Co.	accessdata.fda.gov
May 18, 2012	K113622	ORION II CT CVC	FOZ	Substantially Equivalent	Health Line International Corporation (Hlic)	accessdata.fda.gov
November 18, 2011	K102833	DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS	MPB	Substantially Equivalent	Foshan Nanhai Bai HE Medical Technology Co., Ltd.	accessdata.fda.gov
July 9, 2010	K100907	NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL	LYY	Substantially Equivalent	Siam Sempermed Corp., Ltd.	accessdata.fda.gov
March 11, 2010	K092886	WELL LEAD ENDOBRONCHIAL TUBES	CBI	Substantially Equivalent	Well Lead Instruments	accessdata.fda.gov
January 29, 2010	K090427	URSA ANGIOGRAPHIC CATHETER	DQO	Substantially Equivalent	Curative Medical Technology, Inc.	accessdata.fda.gov
January 21, 2010	K092250	MEDLINE RED RUBBER URETHRAL CATHETER	EYB	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
October 16, 2009	K091516	WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR	EZL	Substantially Equivalent	Well Lead Medical Co., Ltd.	accessdata.fda.gov
July 2, 2009	K083686	BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES	FMF	Substantially Equivalent	Anhui Kangda Medical Products Co., Ltd.	accessdata.fda.gov
June 11, 2009	K083687	BAIXIN INTRAVASCULAR ADMINISTRATION SET	FPA	Substantially Equivalent	Anhui Kangda Medical Products Co., Ltd.	accessdata.fda.gov
October 8, 2008	K082815	WELL LEAD SILICONE AND LATEX FOLEY CATHETERS	EZL	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
July 10, 2008	K073383	WELL LEAD REINFORCED ENDOTRACHEAL TUBE	BTR	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
July 31, 2007	K070451	ABLE CENTRAL VENOUS CATHETER	FOZ	Substantially Equivalent	Foshan Nanhai Bai HE Medical Technology Co., Ltd.	accessdata.fda.gov
July 27, 2007	K063757	MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES	KGO	Substantially Equivalent	Shanghai Motex Healthcare Co., Ltd.	accessdata.fda.gov
August 11, 2006	K053519	SAFETY SYRINGE	MEG	Substantially Equivalent	Wuxi Yushou Medical Applicances Co., Ltd.	accessdata.fda.gov
February 18, 2005	K042683	WELL LEAD ENDOTRACHEAL TUBE	BTR	Substantially Equivalent	Well Lead Medical Instruments	accessdata.fda.gov
December 30, 2004	K033210	BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET	FAD	Substantially Equivalent	Bioteque Corp.	accessdata.fda.gov
May 2, 2003	K030207	NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735	LZA	Substantially Equivalent	Shanghai Motex Healthcare Co., Ltd.	accessdata.fda.gov
December 2, 2002	K020837	MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE	LYY	Substantially Equivalent	Shanghai Motex Healthcare Co., Ltd.	accessdata.fda.gov
September 4, 1998	K973477	BIOSENSORS EMBOLECTOMY CATHETER	DXE	Substantially Equivalent	Sunscope Intl., Inc.	accessdata.fda.gov

Compare with other makers

Updated May 16, 2025. 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.