Is this your brand? Sign in to claim ownership.
Sign in to claim this brandMARINA MEDICAL INSTRUMENTS, INC.
US
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
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000124817
- DUNS Number
- —
Catalogue (3681)
Page 25 of 74| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Marina Medical | 110-685S | FDA UDI | Class I | Active |
| Marina Medical | 172-218 | FDA UDI | Class I | Active |
| Marina Medical | 440-214 | FDA UDI | Class I | Active |
| Marina Medical | 332-016R | FDA UDI | Class I | Active |
| Marina Medical | 410-326 | FDA UDI | Class I | Active |
| Marina Medical | 289-248 | FDA UDI | Class I | Active |
| Marina Medical | 070-504LC | FDA UDI | Class I | Active |
| Marina Medical | 190-332 | FDA UDI | Class I | Active |
| Marina Medical | 380-508 | FDA UDI | Class I | Active |
| Marina Medical | BRK3.00 | FDA UDI | Class II | Active |
| Marina Medical | 300-159 | FDA UDI | Class II | Active |
| Marina Medical | 260-117 | FDA UDI | Class I | Active |
| Marina Medical | 110-833R | FDA UDI | Class I | Active |
| Marina Medical | 044-100 | FDA UDI | Class I | Active |
| Marina Medical | 289-261 | FDA UDI | Class I | Active |
| Marina Medical | BRK1.75S | FDA UDI | Class II | Active |
| Marina Medical | 190-181 | FDA UDI | Class I | Active |
| Marina Medical | 110-729 | FDA UDI | Class I | Active |
| Marina Medical | 060-432 | FDA UDI | Class I | Active |
| Marina Medical | 110-716 | FDA UDI | Class I | Active |
| Marina Medical | 310-224 | FDA UDI | Class I | Active |
| Marina Medical | 260-610 | FDA UDI | Class I | Active |
| Marina Medical | 070-344F | FDA UDI | Class I | Active |
| Marina Medical | 110-470 | FDA UDI | Class I | Active |
| Marina Medical | 120-588 | FDA UDI | Class I | Active |
| Marina Medical | 300-013 | FDA UDI | Class I | Active |
| Marina Medical | 110-681 | FDA UDI | Class I | Active |
| Marina Medical | 033-010B | FDA UDI | Class I | Active |
| Marina Medical | 034-015 | FDA UDI | Class II | Active |
| Marina Medical | 171-674 | FDA UDI | Class I | Active |
| Marina Medical | 336-713 | FDA UDI | Class I | Active |
| Marina Medical | 150-586B | FDA UDI | Class I | Active |
| Marina Medical | 110-322L | FDA UDI | Class I | Active |
| Marina Medical | 254-815C | FDA UDI | Class I | Active |
| Marina Medical | 070-122 | FDA UDI | Class I | Active |
| Marina Medical | 190-261 | FDA UDI | Class I | Active |
| Marina Medical | 1570-BR5 | FDA UDI | Class I | Active |
| Marina Medical | 110-902 | FDA UDI | Class I | Active |
| Marina Medical | 33725-17 | FDA UDI | Class I | Active |
| Marina Medical | 110-686L | FDA UDI | Class I | Active |
| Marina Medical | 800-812 | FDA UDI | Class I | Active |
| Marina Medical | 042-046 | FDA UDI | Class I | Active |
| Marina Medical | 220-322 | FDA UDI | Class I | Active |
| Marina Medical | 350-388XLNC | FDA UDI | Class I | Active |
| Marina Medical | 050-712CER | FDA UDI | Class I | Active |
| Marina Medical | 400-924 | FDA UDI | Class I | Active |
| Marina Medical | 420-870 | FDA UDI | Class I | Active |
| Marina Medical | 289-265 | FDA UDI | Class I | Active |
| Marina Medical | 110-395 | FDA UDI | Class I | Active |
| Marina Medical | 202-014 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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. |