Marina Medical Instruments Inc.
Davie, FL, US
MARINA MEDICAL INSTRUMENTS, INC. appears in FDA device records in Davie, FL. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Marina Medical Instruments Inc. between 2001 and 2005. The busiest year on record is 2003, with 3. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2003 | 3 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042534 | MARINA MEDICAL FINGER PROTECTORS | KGO | Substantially Equivalent | |
| K031463 | MARINA MEDICAL SILICONE PESSARY | HHW | Substantially Equivalent | |
| K021876 | MAS WITH OR WITHOUT SYRINGE | HHK | Substantially Equivalent | |
| K023725 | HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 | GDW | Substantially Equivalent | |
| K010296 | UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 | LKF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2084346 | 1000124817 | MARINA MEDICAL INSTRUMENTS, INC. | 8190 West State Road 84, Davie, FL 33324 US | 2026 | and 86 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- FNYBasin, Emesis
- GESBlade, Scalpel
- FXMCamera, Still, Endoscopic
- FWDCamera, Television, Microsurgical, Without Audio
- GEACannula, Surgical, General & Plastic Surgery
- FYFCap, Surgical
- GEJCarrier, Ligature
- GBXCatheter, Irrigation
- GDJClamp, Surgical, General & Plastic Surgery
- HGCClamp, Uterine
- HHKCurette, Suction, Endometrial (And Accessories)
- FZSCurette, Surgical, General Use
- HCYCurette, Uterine
- FAJCystoscope And Accessories, Flexible/Rigid
- GFDDermatome
- HDQDilator, Cervical, Fixed Size
- GDIDissector, Surgical, General & Plastic Surgery
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GEGElevator, Surgical, General & Plastic Surgery
- EMIFile, Bone, Surgical
- GEOFile, Surgical, General & Plastic Surgery
- HFBForceps, Biopsy, Gynecological
- GENForceps, General & Plastic Surgery
- HNRForceps, Ophthalmic
- GDZHandle, Scalpel
- FHQHolder, Needle, Gastroenterologic
- HDEHook, Fibroid, Gynecological
- HNQHook, Ophthalmic
- GDGHook, Surgical, General & Plastic Surgery
- EIYInstrument, Filling, Plastic, Dental
- HCFInstrument, Ligature Passing And Knot Tying
- DWSInstruments, Surgical, Cardiovascular
- EMFKnife, Surgical
- FHNLigator, Hemorrhoidal
- FSXLight, Surgical, Connector
- FZZMarker, Skin
- GAANeedle, Aspiration And Injection, Disposable
- FWZOperating Room Accessories Table Tray
- GFIOsteotome, Manual
- HHWPessary, Vaginal
- FTNPlastic Surgery And Accessories Kit
- EXXProbe, Rectal, Non-Powered
- HNKProbe, Trabeculotomy
- BRWProtector, Dental
- HHFRemover, Intrauterine Device, Contraceptive, Hook-Type
- GADRetractor
- FDGRetractor, Fiberoptic
- HDLRetractor, Vaginal
- HNFScissors, Ophthalmic
- HHMSound, Uterine
- EQHSource, Carrier, Fiberoptic Light
- EPYSpeculum, Ent
- FFQSpeculum, Rectal
- HDFSpeculum, Vaginal, Metal
- GDWStaple, Implantable
- FTYTape, Measuring, Rulers And Calipers
- FSMTray, Surgical, Instrument
- FCZTube, Smoke Removal, Endoscopic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1208-2010 | VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100, VNVD Veronikis Neo Vaginal Dilator - 1.5cm Tip:Width:0.625in Catalog No. 270-115 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 2.5cm Tip:Width:0.625in Catalog No. 270-125 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 3.5cm Tip:Width:0.625in Catalog No. 270-135 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 4.5cm Tip:Width:0.625in Catalog No. 270-145 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 5.5cm Tip:Width:0.625in Catalog No. 270-155 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Partial Taper Couple: Width:0.625in - 1in Catalog No. 270-165 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Full Taper Couple: Width:0.625in - 1in Catalog No. 270-175 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Coupler 3cm Length: Width: 1in Catalog No. 270-185 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Small Base, Screw Length 2cm Tip: Width: 1in Catalog No. 270-195 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 1.5cn Tip: Width:0.625in Catalog No. 270-199 (sold individually). For use in securing open the opening during examination of the vaginal body cavity. For the Non-Surgical Neo Vagina. | 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. | Terminated | ||
| Z-1207-2010 | VVD Veronikis Vaginal Dilator - Complete Set Catalog No. 270-000. Set Includes: VVD Veronikis Vaginal Dilator - 3cm Tip: Width: 1.00in Catalog No. 270-003 (sold individually) VVD Veronikis Vaginal Dilator - 5cm Tip: Width: 1.00in Cat No. 270-005 (sold individually) VVD Veronikis Vaginal Dilator - 7cm Tip: Width: 1.00in Catalog Np. 270-007 (sold individually) VVD Veronikis Vaginal Dilator - 1cm Spacer: Width: 1.00in Catalog No. 270-009 (sold individually) VVD Veronikis Vaginal Dilator - 2cm Spacer: Width: 1.00in Catalog No. 270-011 (sold individually) VVD Veronikis Vaginal Dilator - 7cm Coupler: Width: 1.00in Catalog No. 270-013 (sold individually) VVD Veronikis Vaginal Dilator - Small Base, Screw 4cm: Width: 1.00in Catalog No. 270-015 (sold individually) VVD Veronikis Vaginal Dilator - Large Base, Screw 4cm: Width: 1.75in Catalog No. 270-017 (sold individually). For use in securing open the opening during examination of the vaginal body cavity. for the Post-Surgical Vagina. | 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. | Terminated | ||
| Z-1206-2010 | VIPA Veronikis Intra-Fiberoptic Pelvic Assistant, Set Catalog No 350-370. VIPA Set Includes: VIPA Urethropexy Tip Catalog No. 350-374 (Also sold individually); VIPA Urethropexy Elbow Catalog No. 350-375 (also sold individually); VIPA Vaginal Cuff Tips (small) Catalog No. 350-376 (Also sold individually); VIPA Vaginal Cuff Tips (large) Catalog No. 350-378 (Also sold individually); VIPA Rectal Probe Catalog No. 350-380 (Also sold Individually); VIPA Fiber Optic Cable (Storz to ACMI Connection) Catalog No. 350-372 (Also sold individually). For use in Urethropexy Procedures and Paravaginal Repairs (accurate suture placement by illuminating the anatomy lateral to the bladder neck); in Sacrocolpopexy (steadies the vaginal vault and provides a suture platform with fiberoptic illumination); in Vaginal surgery (illuminates the rectum to visualize endometriosis lesions on the rectovaginal septum). | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain