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MARINA MEDICAL INSTRUMENTS, INC.

Last updated September 17, 2026

What MARINA MEDICAL INSTRUMENTS, INC. makes

Marina Medical Instruments, Inc. manufactures reusable surgical instruments, including vascular dilators, general-purpose surgical scissors, alligator-style soft-tissue forceps, reusable vaginal speculums, liposuction cannulas, suturing needle holders, and dressing forceps. The company also produces a vaginal dilator designed for medical procedures.

The company’s products are regulated under FDA’s 510(k) clearance process, with devices classified as Class I and Class II. These instruments are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Marina Medical Instruments, Inc. manufacture?

Marina Medical Instruments, Inc. specializes in reusable surgical instruments. Their product line includes vascular dilators, general-purpose surgical scissors, alligator-style soft-tissue manipulation forceps, reusable vaginal speculums, liposuction system cannulas, suturing needle holders, and dressing/utility forceps. These instruments are designed for various surgical and procedural applications, ensuring precision and durability for repeated use.

Where is Marina Medical Instruments, Inc. based?

Marina Medical Instruments, Inc. is headquartered in the United States. The company’s location ensures compliance with U.S. medical device regulations, including those governing manufacturing, labeling, and distribution.

Which regulatory registries list Marina Medical Instruments, Inc.’s devices?

Marina Medical Instruments, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers and regulators to verify device details, compliance, and manufacturing information.

How are Marina Medical Instruments, Inc.’s devices classified under U.S. regulations?

Marina Medical Instruments, Inc.’s devices fall under FDA classifications of Class I and Class II. Class I devices are generally low-risk and subject to general controls, while Class II devices require additional premarket notification (510(k)) clearance to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use and potential risk to patients.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 8190 West State Road 84, Davie, FL, 33324
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000124817
DUNS Number: —

Catalogue (3681)

Page 19 of 74

Device	Model / Reference	Registries	Class	Status
Marina Medical	332-222	FDA UDI	Class I	Active
Marina Medical	110-054LC	FDA UDI	Class I	Active
Marina Medical	290-830XXL	FDA UDI	Class I	Active
Marina Medical	110-716A	FDA UDI	Class I	Active
Marina Medical	190-296NC	FDA UDI	Class I	Active
Marina Medical	180-065	FDA UDI	Class II	Active
Marina Medical	110-065	FDA UDI	Class I	Active
Marina Medical	300-023	FDA UDI	Class I	Active
Marina Medical	020-080	FDA UDI	Class I	Active
Marina Medical	110-803F	FDA UDI	Class I	Active
Marina Medical	521-556	FDA UDI	Class I	Active
Marina Medical	420-560	FDA UDI	Class I	Active
Marina Medical	254-661	FDA UDI	Class I	Active
Marina Medical	161-530	FDA UDI	Class I	Active
Marina Medical	800-368	FDA UDI	Class I	Active
Marina Medical	050-184SC	FDA UDI	Class I	Active
Marina Medical	250-602	FDA UDI	Class I	Active
Marina Medical	572-518	FDA UDI	Class I	Active
Marina Medical	260-100M	FDA UDI	Class I	Active
Marina Medical	BD2.50	FDA UDI	Class II	Active
Marina Medical	400-913	FDA UDI	Class I	Active
Marina Medical	060-368	FDA UDI	Class I	Active
Marina Medical	190-309	FDA UDI	Class I	Active
Marina Medical	800-512	FDA UDI	Class I	Active
Marina Medical	171-650	FDA UDI	Class I	Active
Marina Medical	110-787	FDA UDI	Class I	Active
Marina Medical	336-132	FDA UDI	Class I	Active
Marina Medical	280-604	FDA UDI	Class I	Active
Marina Medical	800-395D	FDA UDI	Class II	Active
Marina Medical	289-405	FDA UDI	Class I	Active
Marina Medical	202-012	FDA UDI	Class I	Active
Marina Medical	060-174	FDA UDI	Class I	Active
Marina Medical	172-810	FDA UDI	Class I	Active
Marina Medical	050-335SC	FDA UDI	Class I	Active
Marina Medical	050-006	FDA UDI	Class I	Active
Marina Medical	336-412	FDA UDI	Class I	Active
Marina Medical	110-825B	FDA UDI	Class I	Active
Marina Medical	050-307	FDA UDI	Class I	Unknown
Marina Medical	BCU29DP	FDA UDI	Class II	Active
Marina Medical	254-730NC	FDA UDI	Class I	Active
Marina Medical	350-386A	FDA UDI	Class I	Active
Marina Medical	190-638LC	FDA UDI	Class I	Active
Marina Medical	070-302	FDA UDI	Class I	Active
Marina Medical	172-115	FDA UDI	Class I	Active
Marina Medical	400-913LH	FDA UDI	Class I	Active
Marina Medical	254-615	FDA UDI	Class I	Active
Marina Medical	050-425	FDA UDI	Class I	Active
Marina Medical	380-609	FDA UDI	Class I	Active
Marina Medical	040-070RLC	FDA UDI	Class I	Active
Marina Medical	280-313	FDA UDI	Class I	Active

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Authorities

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Marina Medical Instruments, Inc. has three recall records, all initiated on 2009-04-09, with each listed as terminated. The recalls involved 46 different 350 series devices and 47 different 270 series products, citing that the manufacturing material lacked proven biocompatibility, which posed a risk of temporary skin or tissue irritation.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 9, 2009	Z-1208-2010	—	terminated	Marina Medical, Sunrise, FL initiated recall of 46 products of 350 series devices and 47 products of 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.
Apr 9, 2009	Z-1206-2010	—	terminated	Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.
Apr 9, 2009	Z-1207-2010	—	terminated	Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.