Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005609751

FEI Number

3005609751

Entity Name

Forsure Medical Products LLC.

City/State/Country

Doral, FL, US

Establishment Address

1303 Nw 78th Ave, Doral, FL 33126, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Forsure Medical Products LLC. (Owner Number: 9100820)

Owner / Operator Contact Address

1303 NW 78th Ave, --, Doral, FL 33126, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Forsure Male External Catheter Forsure Disposable Underpad Forsure Hypodermic Needle Forsure Syringe with/without Needle Forsure Resucitator Forsure Intubating Stylet Forsure Tracheal Tube Introducer Bougie Forsure Skin Stapler Forsure IV Catheter Forsure Skin Staple Remover Forsure IV Sets Forsure Oropharyngeal Airway Forsure Laryngeal Mask Airway Forsure Nasal Cannula Forsure Endotracheal Tube with Evacuation Lumen Forsure Reinforced Endotracheal Tube Forsure Oxygen Mask Non-Rebreathing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2026-05-14
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2026-05-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-05-15
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-05-15
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2020-05-07
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2020-05-07
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2020-05-07
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2020-05-07
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2026-05-15
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-06-16
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2026-05-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-02-02
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2020-05-07
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2020-05-07
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2020-05-13
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2020-05-13
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2020-05-13

Official Correspondent

Luis Arias, Jr.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Forsure Medical Products LLC.

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
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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K812140	3M Company	BIRD MEAN AIRWAY PRESSURE MONITOR	1981-08-20
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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3014982318	HONG MING ENTERPRISE CO., LTD.	Taichung City, TW
3004450493	MRK HEALTHCARE PVT.LTD	PATAN Gujarat, IN
3006606901	COLOPLAST HUNGARY KFT	NYIRBATOR Szabolcs-Szatmar-Bereg, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005609751. Last updated year: 2026. Please use registration number 3005609751 when referencing this establishment in official correspondence.