Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012050423

FEI Number

3012050423

Entity Name

MEDAS, INC.

City/State/Country

Miami, FL, US

Establishment Address

20855 NE 16TH Avenue, C21, Miami, FL 33179, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Medas, Inc. (Owner Number: 10053534)

Owner / Operator Contact Address

20855 NE 16th Ave, Suite C21, Miami, FL 33179, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K033210

PMA Number

N/A

All Registered Proprietary Names

MEDADV Nasopharyngeal Airway MEDADV Circular Stapler MEDADV ONSET INTRODUCER CATHETER Power free Sterile Surgical Gloves MEDADV SHARE STOPCOCK MEDADV SHARE MANIFOLD Nitrile Surgical Gloves MEDADV XPANDER RX PTA PTA BALLOON CATHETER MEDADV Ostomy Bag MEDADV Encourage Transluminal Percutaneous Catheters Surgeon ;s Gloves MEDADV Nebulizer Mask MEDADV BLOW INFLATION DEVICE MEDADV Nasal Cannula MEDADV Reinforced Endotracheal Tube MEDADV HEMODIALYSIS CATHETER Intravascular Administration Set SPOTTER ANGIOGRAPHIC CATHETER MEDADV Central Venous Catheter MEDADV ARTERIAL EMBOLECTOMY CATHETER MEDADV Umbrella Shield lock Needle MEDADV Umbrella Shield Lock Safety syringe Intravascular Catheter Tracheal/Bronchial Differential Ventilation Tube MEDADV Breathing (W Connector, Adaptor, Y Piece) circuit Medas, Inc Medadv X-Ray Detectable Gauze sponges Sterile all sizes Medadv X-Ray Detectable Lap Sponges Sterile all sizes Medadv X-Ray Detectable Gauze Sponges Non Sterile all sizes Medadv X-Ray Detectable Lap Sponges Non Sterile all sizes Surgeons Gloves MEDADV Retention Balloon Catheter MEDADV Turtle Retractable Safety Syringe MEDADV LATEX POWDER FREE EXAMINATION GLOVES MEDADV Ostomy Disposable Seal MEDADV Press Vascular Clamp MEDADV Hauler Hydrophilic Guide Wire MEDADV CENTRAL VENOUS CATHETER Medadv Woven Gauze Sponges Sterile all sizes Medadv Zig Zag Gauze Rolls all sizes and mesh Medadv Non Woven Gauze Sponges Non Sterile Medadv Woven Gauze Sponges Non Sterile all sizes Medadv Gauze Rolls all sizes and mesh Medadv Non Woven Gauze Sponges Sterile Polymer patient glove MEDADV Hemodialysis Non Implantable Catheter MEDADV DOUBLE PIGTAIL (J TYPE) URETERAL STENT SET

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2025-01-23
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2017-02-08
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2017-03-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2017-03-25
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-12-27
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2025-01-23
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-01-17
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-12-17
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-02-08
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2025-01-17
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2017-04-13
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2017-03-25
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-01-16
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2017-02-08
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2018-08-24
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2017-02-08
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2017-02-08
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2026-01-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-01-17
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2026-02-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2023-12-26
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-02-08
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2025-01-17
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-01-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-01-15
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-01-16
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2017-02-08
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2017-02-08
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2017-01-16
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2019-03-06
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2017-01-20
EZL	Catheter, Retention Type, Balloon	Gastroenterology, Urology	Class 2	876.5130	2017-03-02
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2018-07-31
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2019-01-15
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2019-12-23
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2017-04-13
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2017-03-25
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-04-19
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-02-03
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-03-06
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2017-01-16
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2017-02-08
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2023-12-27

Official Correspondent

Juan Basalo

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medas, 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
K233013	Silq Technologies Corporation	2-Way 100% Silicone Cleartract Catheter	2024-01-23
K221629	Covidien	Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)	2023-02-22
K231491	Covidien	TA Stapler and Loading Unit with DST Series Technology	2023-08-16
K131563	Opus Ksd, Inc.	SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM	2014-04-09
K131705	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY	2013-07-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0070-2019	COVIDIEN LLC	2	EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.
Z-0001-2021	N/A	2	Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012050423. Last updated year: 2026. Please use registration number 3012050423 when referencing this establishment in official correspondence.