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Infinity Medical International LLC: FDA-registered device maker in Miami, FL, United States, 1 510(k) clearance

Name: Infinity Medical International LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Infinity Medical International LLC is registered with the FDA (registration 3037966040) in Miami, FL, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 4, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3037966040
Address: 245 Se 1st St Ste 214, Miami, FL, United States, 33131
Owner or operator: infinity medical (10093099)
Roles: Manufacturer for export, Repackager or relabeler
First device listed: March 2, 2026
Registered through: 2026
Brand names listed: Hybrid medf1rst resectoscope and accessories, MEDF1RST RIGID CYSTOSCOPE: MF027190CP MF04302C MF1227190CP MF124302C MF3027190CP MF304302C MF7027190CP MF704302C, Medf1rst laparoscopic instruments, Medf1rst needle holder, SEMI RIGID URETEROSCOPE MEDF1RST: MF430.4.5.1C MF430.6.1C MF430.6.2C MF430.8.1C MF430.8.2C, Thulium laser 60w

Devices it lists

Device	Product code	Class	Role	Source
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Manufacturer for export	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Manufacturer for export	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Manufacturer for export	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler	accessdata.fda.gov
Resectoscope	FJL	2	Manufacturer for export	accessdata.fda.gov
Ureteroscope And Accessories, Flexible/Rigid	FGB	2	Manufacturer for export	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
November 4, 2025	K251303	Tamburo Thulium Fiber Laser System	GEX	Substantially Equivalent	Menovex Medical Technology (Shenzhen) Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 4, 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.