Data / Medical devices / United States / Mermaid Medical A/S (FL Site)

Mermaid Medical A/S (FL Site): FDA-registered device maker in University Park, FL, United States, 5 510(k) clearances

Name: Mermaid Medical A/S (FL Site) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Mermaid Medical A/S (FL Site) is registered with the FDA (registration 3027260597) in University Park, FL, United States. It lists 8 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 22, 2025. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Mermaid Medical A/S (FL Site)

FDA registration number: 3027260597
Address: 8033 Cooper Creek Blvd Ste 106, University Park, FL, United States, 34201
Owner or operator: Mermaid Medical (10045264)
Roles: Complaint file establishment, Specification developer
First device listed: November 21, 2013
Registered through: 2027
Brand names listed: Angel® Catheter, Angel® Catheter Accesory Kit, Angel® Catheter Accessory Kit, M- Drain Catheter, M-Biopsy, M-Drain Percutaneous Introducer System

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Nephrostomy	LJE	U	Complaint file establishment	accessdata.fda.gov
Catheter, Nephrostomy, General & Plastic Surgery	GBO	1	Complaint file establishment	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Needle, Biopsy, Cardiovascular	DWO	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Short-Term Intravascular Filter Catheter	PNS	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Complaint file establishment	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Complaint file establishment, Specification developer	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
December 22, 2025	K251019	BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G	FGE	Substantially Equivalent	Bioteque Corporation	accessdata.fda.gov
July 28, 2016	K160747	Angel Catheter	PNS	Substantially Equivalent	Bio2 Medical, Inc.	accessdata.fda.gov
May 27, 2011	K092338	MEDAX UNIPERSONALE SRL	KNW	Substantially Equivalent	Medax Unipersonale Srl	accessdata.fda.gov
October 31, 2007	K071330	GALTSTICK INTRODUCER SYSTEM	DRE	Substantially Equivalent	Galt Medical Corp.	accessdata.fda.gov
March 31, 1994	K935170	CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS	DQX	Substantially Equivalent	Lake Region Mfg., Inc.	accessdata.fda.gov

Compare with other makers

Updated December 22, 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.