Data / Medical devices / United States / Marina Medical Instruments, Inc.
Marina Medical Instruments, Inc.: FDA-registered device maker in Davie, FL, United States, 8 510(k) clearances
Marina Medical Instruments, Inc. is registered with the FDA (registration 2084346) in Davie, FL, United States. It lists 96 device types. The FDA files 8 510(k) clearances under its listings, the newest dated November 26, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2084346
- FEI number
- 1000124817
- Address
- 8190 West State Road 84, Davie, FL, United States, 33324
- Owner or operator
- Marina Medical Instruments (9001093)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 4, 2000
- Registered through
- 2026
- Brand names listed
- 6-Hole Cannula, Adson Brown Forceps, Adson Dressing Forceps, Adson Forceps, Adson Tissue Forceps, Adson-Brown Tissue Forceps, Adson-DeBakey Forceps, Agris Dingman Dissector and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Catheter | KGZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Arthroscope | HRX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Basin, Emesis | FNY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Binder, Medical, Therapeutic | MDR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Block, Cutting, Ent, Non-Sterile | NNR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Caliper | KTZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Camera, Still, Endoscopic | FXM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Camera, Television, Microsurgical, Without Audio | FWD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Manipulator/Injector, Uterine | LKF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Carrier, Ligature | GEJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp | HXD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Uterine | HGC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette, Uterine | HCY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Depressor, Metal Tongue, Surgical | KBL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dermatome | GFD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Extractor | HWB | 1 | Repackager or relabeler | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Repackager or relabeler | accessdata.fda.gov |
| File, Surgical, General & Plastic Surgery | GEO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Gynecological | HFB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ent | KAE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Fibroid, Gynecological | HDE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Ophthalmic | HNQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cast Application/Removal, Manual | LGG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Filling, Plastic, Dental | EIY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Surgical | EMF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Label Or Tag, Sterile | LYV | 1 | Repackager or relabeler | accessdata.fda.gov |
| Ligator, Hemorrhoidal | FHN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Light, Surgical, Connector | FSX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Loop, Wire | JYQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mallet | HXL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mirror, Ent | KAI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Nipper, Malleus | JYR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Operating Room Accessories Table Tray | FWZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pessary, Vaginal | HHW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Plastic Surgery And Accessories Kit | FTN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Rectal, Non-Powered | EXX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Probe, Trabeculotomy | HNK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rasp, Nasal | KBA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Ent | KAL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Fiberoptic | FDG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Vaginal | HDL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur, Nasal | KBB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Nasal | KBD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Ophthalmic | HNF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Sound, Uterine | HHM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Source, Carrier, Fiberoptic Light | EQH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Speculum, Vaginal, Metal | HDF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spoon, Ear | JZE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Ear Suction | JZF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Smoke Removal, Endoscopic | FCZ | 1 | Repackager or relabeler | 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 26, 2025 | K252260 | RELIEEV HSG Catheter (HSG7FA1) | LKF | Substantially Equivalent | Li Medical Corporation , Ltd. | accessdata.fda.gov |
| October 16, 2024 | K240364 | RELIEEV Uterine Manipulator Injector (CUMI 5.0) | LKF | Substantially Equivalent | Li Medical Corporation , Ltd. | accessdata.fda.gov |
| March 11, 2010 | K092980 | PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| June 17, 2004 | K041094 | HSG CATHETER SET | LKF | Substantially Equivalent | Bioteque America, Inc. | accessdata.fda.gov |
| December 27, 2001 | K013289 | BIOTEQUE VAGINAL PESSARIES | HHW | Substantially Equivalent | Bioteque America, Inc. | accessdata.fda.gov |
| December 15, 1999 | K993689 | AED CYSTOSCOPE | FAJ | Substantially Equivalent | National Advanced Endoscopy Devices, Inc. | accessdata.fda.gov |
| December 2, 1999 | K991656 | AED ARTHROSCOPE | HRX | Substantially Equivalent | National Advanced Endoscopy Devices, Inc. | accessdata.fda.gov |
| August 14, 1997 | K964176 | TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS | GEI | Substantially Equivalent | Tecno Instruments (Usa), Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|
| April 9, 2009 | 53501 | Not yet classified | Terminated | VIPA Veronikis Intra-Fiberoptic Pelvic Assistant, Set Catalog No. VIPA Set Includes: VIPA Urethropexy Tip Catalog No. (Also sold individually); VIPA Urethropexy Elbow Catalog No. (also sold individually); VIPA Vaginal Cu | 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. | accessdata.fda.gov |
Compare with other makers
Updated November 26, 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.