FDA Device Registration & Listing · Jacksonville, FL, US · Registration 3004001706
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| NTN | Led Light Source | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-07-17 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-24 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-05 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 2023-04-18 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-09-08 |
| FTA | Light, Surgical, Accessories | General, Plastic Surgery | Class 2 | 878.4580 | 2024-07-17 |
| GAI | Stripper, Vein, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-31 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-09-09 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-09-08 |
| GAZ | Tubing, Noninvasive | General Hospital | Class 2 | 880.6740 | 2024-11-18 |
| FHN | Ligator, Hemorrhoidal | Gastroenterology, Urology | Class 2 | 876.4400 | 2022-05-05 |
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | Class 1 | 878.4160 | 2024-07-17 |
| KBM | Dissector, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-06-07 |
| JYY | Rasp, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-31 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-06-07 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-05 |
| GBB | Chair, Surgical, Ac-Powered | General, Plastic Surgery | Class 1 | 878.4960 | 2024-07-17 |
| JZC | Searcher, Mastoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-06-29 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2024-07-17 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-05 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-08-15 |
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | Class 2 | 880.6740 | 2024-07-17 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2024-06-07 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-05 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2022-05-05 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-06-07 |
| GEC | Brush, Scrub, Operating-Room | General, Plastic Surgery | Class 1 | 878.4800 | 2024-07-17 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2022-05-05 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2022-05-05 |
| HPP | Headlamp, Operating, Battery-Operated | Ophthalmic | Class 1 | 886.4335 | 2024-07-17 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-05-05 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2022-05-05 |
| JZE | Spoon, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-09-09 |
| KCL | Blower, Powder, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2024-05-31 |
| HWN | Instrument, Compression | Orthopedic | Class 1 | 888.4540 | 2024-05-31 |
| JYP | Knife, Myringotomy | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-29 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-09-08 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 2022-05-05 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-05 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-31 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2022-05-05 |
| HOD | Clamp, Eyelid, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-05-31 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2022-05-05 |
| JYF | Clamp, Ossicle Holding | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-24 |
| HXY | Brace, Drill | Orthopedic | Class 1 | 888.4540 | 2024-05-31 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2022-05-05 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2024-07-17 |
| FBX | Sound, Urethral, Metal Or Plastic | Gastroenterology, Urology | Class 1 | 876.5520 | 2022-09-08 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2022-09-08 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2022-09-14 |
| PUA | Tenaculum, Uterine, Exempt | Obstetrics/Gynecology | Class 2 | 884.4530 | 2024-07-17 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-03-07 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2022-05-05 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2022-09-08 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-05-05 |
| EIB | Syringe, Irrigating (Dental) | Dental | Class 1 | 872.4565 | 2024-06-07 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-31 |
| FXG | Specula Accessories | General, Plastic Surgery | Class 1 | 878.1800 | 2022-09-08 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2022-09-08 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-05-05 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-09-09 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-05 |
| JYM | Inserter, Myringotomy Tube | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-06-07 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2022-09-08 |
| QFZ | Gastroenterology-Urology Accessories To A Biopsy Instrument | Gastroenterology, Urology | Class 1 | 876.1080 | 2024-07-17 |
| FDG | Retractor, Fiberoptic | Gastroenterology, Urology | Class 1 | 876.4530 | 2023-02-10 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-31 |
| KCG | Dilator, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-06-07 |
| KYW | Container, Liquid Medication, Graduated | General Hospital | Class 1 | 880.6430 | 2022-05-05 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2023-04-14 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-07-17 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-09-09 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2022-09-14 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2022-09-08 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-05 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-05-05 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2024-06-07 |
| EQH | Source, Carrier, Fiberoptic Light | Ear, Nose, Throat | Class 1 | 874.4350 | 2024-07-17 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-05-05 |
| HWK | Trephine | Orthopedic | Class 1 | 888.4540 | 2024-06-07 |
| GBP | Catheter, Multiple Lumen | General, Plastic Surgery | Class 1 | 878.4200 | 2025-11-21 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2024-05-31 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2022-09-08 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-05 |
| FFN | Clamp, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2022-09-08 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2024-06-07 |
| HFW | Clamp, Umbilical | Obstetrics/Gynecology | Class 2 | 884.4530 | 2024-07-17 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-06-07 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-05 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-24 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-31 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2022-05-05 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-05-24 |
| BWB | Forceps, Tube Introduction | Anesthesiology | Class 1 | 868.5780 | 2022-09-08 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-03-24 |
| KAM | Cannula, Sinus | General, Plastic Surgery | Class 1 | 878.4800 | 2022-06-24 |
| PHT | Basin For Endoscope Reprocessing | Gastroenterology, Urology | Class 1 | 876.1500 | 2024-06-07 |
| FCT | Headlight, Fiberoptic Focusing | Ophthalmic | Class 2 | 886.4335 | 2024-07-17 |
| HNJ | Punch, Corneo-Scleral | Ophthalmic | Class 1 | 886.4350 | 2023-03-07 |
| GCC | Dilator, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2022-09-08 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Anesthesiology | Class 1 | 868.5640 | 2024-07-17 |
| KCP | Syringe, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2024-06-07 |
| EXX | Probe, Rectal, Non-Powered | Gastroenterology, Urology | Class 1 | 876.4730 | 2022-09-08 |
| FGN | Retractor, Non-Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2022-09-08 |
| JYJ | Gauge, Measuring | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-11-18 |
| JYK | Holder, Ear Speculum | General, Plastic Surgery | Class 1 | 878.1800 | 2024-11-18 |
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2025-09-04 |
| FCW | Light Source, Fiberoptic, Routine | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-07-17 |
| FAX | Bougie, Urological | Gastroenterology, Urology | Class 1 | 876.5520 | 2022-05-05 |
| KAJ | Mobilizer, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-11-18 |
| NJZ | Extractor, Vein | General, Plastic Surgery | Class 1 | 878.4800 | 2022-09-08 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2025-01-29 |
| KAY | Punch, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-03-26 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-05 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2023-03-07 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2024-11-18 |
| GWY | Pinwheel | Neurology | Class 1 | 882.1750 | 2022-05-05 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-03-07 |
| GWZ | Percussor | Neurology | Class 1 | 882.1700 | 2023-03-24 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-05 |
| HHM | Sound, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2022-05-05 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-05-31 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2022-09-08 |
| ERA | Otoscope | Ear, Nose, Throat | Class 1 | 874.4770 | 2022-09-08 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K910471 | Baxter Healthcare Corp | MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE | 1991-03-08 |
| K000397 | Boston Scientific Corp | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL | 2000-03-07 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| K914226 | E.I. Dupont DE Nemours & Co., Inc. | ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK | 1991-11-19 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0012-2008 | Becton Dickinson & Company | 1 | Shelf Pack:
Bard-Parker Rib-Back Carbon Steel no.11, surgical blade.
Unit Package:
Contents of unopened or undamaged package guaranteed sterile;
After use place product in a puncture resistant container and dispose properly.
Becton Dickinson
Becton Dickinson Acute Care
Franklin Lakes, NJ 07417 |
| Z-0013-2008 | Becton Dickinson & Company | 1 | Shelf Pack:
Bard-Parker Rib-Back Stainless Steel no.11, surgical blade.
Unit Package:
Contents of unopened or undamaged package guaranteed sterile;
After use place product in a puncture resistant container and dispose properly.
Becton Dickinson
Becton Dickinson Acute Care
Franklin Lakes, NJ 07417 |
| Z-0034-2012 | X Spine Systems Inc | 1 | Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144
The Axle Torque Driver Handle is used to lock the set screw into the locking plate. |
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| Z-0144-2024 | Covidien | 1 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3006161756 | FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, JP |
| 3022106566 | SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD | Shanghai, CN |
| 1820334 | Cook Incorporated | Bloomington, IN, US |
| 9681260 | Boston Scientific Limited | GALWAY, IE |
| 2020550 | KARL STORZ ENDOSCOPY-AMERICA, INC. | Auburn, MA, US |
3004001706 when referencing this establishment in official correspondence.