FDA Device Registration & Listing · Shanghai, CN · Registration 3005067367
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-23 |
| EKR | Plugger, Root Canal, Endodontic | Dental | Class 1 | 872.4565 | 2023-02-09 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-17 |
| GEJ | Carrier, Ligature | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-16 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-22 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 2023-02-22 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2009-11-13 |
| HGC | Clamp, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-02-16 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-13 |
| KBG | Trocar, Sinus | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-10 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | Neurology | Class 2 | 882.4300 | 2018-08-22 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-26 |
| KAY | Punch, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-06 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-22 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-07 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| GWM | Device, Monitoring, Intracranial Pressure | Neurology | Class 2 | 882.1620 | 2018-08-17 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2023-03-07 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2023-02-27 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2023-02-20 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-24 |
| HBR | Rack, Clip | Neurology | Class 1 | 882.4215 | 2023-02-21 |
| EZM | Dilator, Esophageal (Metal Olive) Gastro-Urology | Gastroenterology, Urology | Class 2 | 876.5365 | 2023-02-23 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-02 |
| HOD | Clamp, Eyelid, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-02-16 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 2023-02-09 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2023-03-07 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-12 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-13 |
| HTT | Burr, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2023-03-08 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-23 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-16 |
| EIL | Gauge, Depth, Instrument, Dental | Dental | Class 1 | 872.4565 | 2023-02-27 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-02-14 |
| KAX | Punch, Ethmoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-06 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2023-02-27 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2023-02-14 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2023-02-27 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2023-03-02 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2023-02-15 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2023-03-08 |
| KAM | Cannula, Sinus | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-23 |
| KTF | Punch, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-07 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-23 |
| JZY | Knife, Laryngeal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-23 |
| HNJ | Punch, Corneo-Scleral | Ophthalmic | Class 1 | 886.4350 | 2023-03-10 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-03-10 |
| GAI | Stripper, Vein, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-22 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-02-27 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2023-03-01 |
| JZA | Rongeur, Mastoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-23 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2023-02-27 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2023-02-23 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2020-03-31 |
| HTP | File | Orthopedic | Class 1 | 888.4540 | 2023-02-13 |
| BWB | Forceps, Tube Introduction | Anesthesiology | Class 1 | 868.5780 | 2023-03-13 |
| HNB | Spoon, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-03-13 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 2023-03-07 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Neurology | Class 2 | 882.4310 | 2018-08-22 |
| LXI | Guide, Drill, Ligament | General, Plastic Surgery | Class 1 | 878.4820 | 2023-02-27 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-23 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| ELA | Instrument, Hand, Calculus Removal | Dental | Class 1 | 872.4565 | 2023-02-14 |
| JYP | Knife, Myringotomy | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-23 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2023-02-13 |
| KAN | Chisel, Nasal | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-21 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-01 |
| KAO | Curette, Ethmoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-13 |
| JYE | Chisel, Middle-Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-23 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-27 |
| EKI | Carrier, Amalgam, Operative | Dental | Class 1 | 872.4565 | 2023-02-09 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-02-23 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-02-14 |
| EXX | Probe, Rectal, Non-Powered | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-03-07 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-02-23 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-15 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2023-02-08 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2017-07-17 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-27 |
| JYF | Clamp, Ossicle Holding | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-16 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2023-03-02 |
| HOC | Clip, Iris Retractor | Ophthalmic | Class 1 | 886.4350 | 2023-03-03 |
| HAB | Saw, Powered, And Accessories | General, Plastic Surgery | Class 1 | 878.4820 | 2023-03-06 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2023-03-02 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-23 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-24 |
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-02-15 |
| HXN | Applier, Cerclage | Orthopedic | Class 1 | 888.4540 | 2023-03-07 |
| HTQ | Broach | Orthopedic | Class 1 | 888.4540 | 2023-03-08 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-07 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-14 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | Orthopedic | Class 1 | 888.4540 | 2023-04-22 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-02-13 |
| KDG | Chisel (Osteotome) | General, Plastic Surgery | Class 1 | 878.4820 | 2023-02-23 |
| FFN | Clamp, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-03-21 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2023-02-24 |
| HDE | Hook, Fibroid, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-03-16 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-03 |
| EKJ | Burnisher, Operative | Dental | Class 1 | 872.4565 | 2023-02-09 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2023-02-14 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-02-21 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2023-04-20 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-02-23 |
| ECN | Clamp, Wire, Orthodontic | Dental | Class 1 | 872.5410 | 2023-02-08 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2023-04-23 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2023-02-23 |
| EWQ | Saw, Surgical, Ent (Electric Or Pneumatic) | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-23 |
| EIK | Carver, Wax, Dental | Dental | Class 1 | 872.4565 | 2023-02-08 |
| FGN | Retractor, Non-Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-02-15 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2023-02-27 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-23 |
| KAW | Punch, Antrum | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-06 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-13 |
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-02-12 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-02-27 |
| GDN | Knife, Amputation | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-23 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-22 |
| KBS | Punch, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-06 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-13 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-07 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-26 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-03-02 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-13 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-13 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2023-03-13 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2023-03-07 |
| FZW | Expander, Surgical, Skin Graft | General, Plastic Surgery | Class 1 | 878.4800 | 2023-04-27 |
| FHA | Clamp, Penile | Gastroenterology, Urology | Class 1 | 876.5160 | 2023-02-27 |
| GXJ | Punch, Skull | Neurology | Class 1 | 882.4750 | 2023-02-26 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-12 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-03-29 |
| HXY | Brace, Drill | Orthopedic | Class 1 | 888.4540 | 2023-03-07 |
| EKD | Instrument, Cutting, Operative | Dental | Class 1 | 872.4565 | 2023-02-08 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2023-02-09 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-23 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-02-22 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-14 |
| KBP | Hook, Tonsil Suturing | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-23 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2023-02-12 |
| FHL | Scoop | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-02-20 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-02-15 |
| KYW | Container, Liquid Medication, Graduated | General Hospital | Class 1 | 880.6430 | 2023-02-24 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2023-03-07 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-02-21 |
| GXL | Screwdriver, Skullplate | Neurology | Class 1 | 882.4900 | 2023-02-26 |
| HDM | Packer, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-03-16 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2023-02-23 |
| FHB | Hook, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2023-03-07 |
| ECS | Pusher, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2023-03-13 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2023-02-27 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2023-02-09 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| JYD | Chisel, Mastoid | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-23 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-02 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-12 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-22 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-21 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-16 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-01 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-13 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-09 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-24 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2023-02-09 |
| HBT | Applier, Hemostatic Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-14 |
| HXR | Spatula, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-07 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2023-02-09 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-01 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | Obstetrics/Gynecology | Class 1 | 884.4520 | 2023-02-27 |
| HWQ | Passer | Orthopedic | Class 1 | 888.4540 | 2023-03-02 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2023-02-16 |
| HRH | Trephine, Manual, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-02-17 |
| EMR | File, Periodontic | Dental | Class 1 | 872.4565 | 2023-03-07 |
| JYY | Rasp, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-03-02 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2023-02-23 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-27 |
| KBQ | Knife, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-02-23 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2023-04-23 |
| GCC | Dilator, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2023-02-22 |
| KYB | Lens, Guide, Intraocular | Ophthalmic | Class 1 | 886.4300 | 2023-02-27 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K914226 | E.I. Dupont DE Nemours & Co., Inc. | ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK | 1991-11-19 |
| K020558 | Integra Neurosciences | LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE | 2002-03-21 |
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| K873512 | Arthropedics, Inc. | SERRATED GRASPING FORCEPS, RIGHT | 1987-11-02 |
| K871646 | Ocular Instruments, Inc. | TANNE CORNEAL CUTTING BLOCK | 1987-05-18 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0026-04 | Surgical Specialties Corp | 1 | Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives. |
| Z-1922-2024 | Alcon Research LLC Aspex Facility | 1 | 20 Gauge V-Lance Knife
Model/Catalog Number: 8065912001
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-1923-2024 | Alcon Research LLC Aspex Facility | 1 | ClearCut Sideport Knife Dual Bevel 1.2mm Angled
Model/Catalog Number: 8065921541
Software Version: N/A
Product Description: Ophthalmic Knife
Component: N/A |
| Z-1924-2024 | Alcon Research LLC Aspex Facility | 1 | ClearCut S Safety Sideport Knife 1.0mm Dual Bevel
Model/Catalog Number: 8065771540
Software Version: N/A
Product Description: Ophthalmic Knife
Component: N/A |
| Z-1925-2024 | Alcon Research LLC Aspex Facility | 1 | ClearCut S Safety Sideport Knife 1.2mm Dual Bevel
Model/Catalog Number: 8065771541
Software Version: N/A
Product Description: Ophthalmic Knife
Component: N/A |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3020155054 | SHALBY ADVANCED TECHNOLOGIES, INC. | El Dorado Hills, CA, US |
| 3003597504 | RSB SPINE LLC. | Wooster, OH, US |
| 1720747 | SONTEC INSTRUMENTS, INC. | CENTENNIAL, CO, US |
| 3014334038 | Integra LifeSciences Production Corporation | Mansfield, MA, US |
| 3000270450 | Synthes GMBH | Selzach Solothurn, CH |
3005067367 when referencing this establishment in official correspondence.