Mermaid Medical A/S

Stenloese Hovedstaden, DK

MERMAID MEDICAL A/S appears in FDA device records in Stenloese Hovedstaden, DK. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 2
Registered establishments: 2

510(k) clearance history

FDA records hold 1 510(k) clearance for Mermaid Medical A/S in 2016.

Clearances by year, as a table

510(k) clearance decisions for Mermaid Medical A/S, by decision year
Year	Clearances
2016	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K161409	M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem	KNW	Substantially Equivalent	2016-08-02

Registered establishments

FDA registered establishments for Mermaid Medical A/S, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3007146453	3007146453	MERMAID MEDICAL A/S	Frydensbergvej 25, Stenloese Hovedstaden DK-3660 DK	2026	DQX DRE DWO FGE GBO LJE PNS
3010605476	3010605476	MERMAID MEDICAL INC	7805 24th Court E, Sarasota, FL 34243 US	2026	No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2213-2024	The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends ending in an eccentric blunt distal tip. Once activated, the shaft rotates at approximately 10.000 RPMs to break thrombus into smaller particles, which can be simultaneously aspirated using a dedicated vacuum syringe. The catheter is a stand-alone system and is powered by a 4.5 VDC alkaline battery pack in the control unit.	Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.	Class II	2024-05-01	Open, Classified
Z-2190-2015	Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.	Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula.	Class II	2015-06-15	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain