FDA Device Registration & Listing · Westmont, IL, US · Registration 3008770252
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HNH | Ring, Ophthalmic (Flieringa) | Ophthalmic | Class 1 | 886.4350 | 2019-03-27 |
| GAI | Stripper, Vein, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| GWY | Pinwheel | Neurology | Class 1 | 882.1750 | 2018-07-23 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2018-07-23 |
| JYF | Clamp, Ossicle Holding | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2019-03-27 |
| HNM | Needle, Ophthalmic Suturing | Ophthalmic | Class 1 | 886.4350 | 2019-03-27 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2019-03-27 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| EKI | Carrier, Amalgam, Operative | Dental | Class 1 | 872.4565 | 2019-03-27 |
| FHB | Hook, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2019-03-27 |
| DRC | Trocar | Cardiovascular | Class 2 | 870.1390 | 2019-03-29 |
| NNN | Crimper, Wire, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2018-07-23 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-03-29 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2019-03-27 |
| HXS | Twister, Wire | Orthopedic | Class 1 | 888.4540 | 2019-03-27 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2018-07-23 |
| HOF | Burr, Corneal, Manual | Ophthalmic | Class 1 | 886.4350 | 2025-12-23 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | Class 2 | 882.4800 | 2019-03-28 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2018-07-23 |
| LRJ | Disinfectant, Medical Devices | General Hospital | Class 1 | 880.6890 | 2025-02-12 |
| HNY | Cystotome | Ophthalmic | Class 1 | 886.4350 | 2019-03-27 |
| GEO | File, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| KCR | Facebow | Dental | Class 1 | 872.3220 | 2019-03-27 |
| JYC | Cannula, Ear | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-23 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2019-03-29 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| IPF | Stimulator, Muscle, Powered | Physical Medicine | Class 2 | 890.5850 | 2021-08-09 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | Physical Medicine | Class 2 | 890.5850 | 2021-08-09 |
| HLN | Gauge, Lens, Ophthalmic | Ophthalmic | Class 1 | 886.1420 | 2019-03-27 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | Neurology | Class 2 | 882.5890 | 2021-08-09 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | Class 2 | 882.5890 | 2021-08-09 |
| FBX | Sound, Urethral, Metal Or Plastic | Gastroenterology, Urology | Class 1 | 876.5520 | 2018-07-23 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 2025-12-23 |
| HCH | Clip, Aneurysm | Neurology | Class 2 | 882.5200 | 2019-03-29 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2018-07-23 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 2018-07-23 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2018-07-23 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| HXY | Brace, Drill | Orthopedic | Class 1 | 888.4540 | 2018-07-23 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2019-03-27 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2019-03-27 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2015-03-08 |
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | Class 1 | 878.5900 | 2019-03-27 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| FXG | Specula Accessories | General, Plastic Surgery | Class 1 | 878.1800 | 2018-07-23 |
| FDG | Retractor, Fiberoptic | Gastroenterology, Urology | Class 1 | 876.4530 | 2019-03-27 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2019-03-27 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2019-04-04 |
| FAX | Bougie, Urological | Gastroenterology, Urology | Class 1 | 876.5520 | 2019-03-27 |
| HDA | Forceps, Obstetrical | Obstetrics/Gynecology | Class 2 | 884.4400 | 2019-03-29 |
| FHN | Ligator, Hemorrhoidal | Gastroenterology, Urology | Class 2 | 876.4400 | 2019-03-29 |
| HXR | Spatula, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-23 |
| JYY | Rasp, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2018-07-23 |
| FFP | Dilator, Rectal | Gastroenterology, Urology | Class 1 | 876.5450 | 2019-03-27 |
| HBO | Clip, Scalp | Neurology | Class 2 | 882.4150 | 2019-03-28 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | Class 1 | 876.4730 | 2019-03-27 |
| FJR | Forceps, Disconnect | Gastroenterology, Urology | Class 1 | 876.5540 | 2025-12-23 |
| HMR | Marker, Ocular | Ophthalmic | Class 1 | 886.4570 | 2018-07-23 |
| GEC | Brush, Scrub, Operating-Room | General, Plastic Surgery | Class 1 | 878.4800 | 2019-03-27 |
| KBE | Snare, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2019-03-27 |
| FHA | Clamp, Penile | Gastroenterology, Urology | Class 1 | 876.5160 | 2018-07-23 |
| KAR | Irrigator, Sinus | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 2019-03-27 |
| KBC | Saw, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| ILH | Splint, Hand, And Components | Physical Medicine | Class 1 | 890.3475 | 2025-12-23 |
| HNP | Introducer, Sphere | Ophthalmic | Class 1 | 886.4350 | 2019-03-27 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2025-02-12 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| HER | Pelvimeter, External | Obstetrics/Gynecology | Class 1 | 884.4520 | 2019-03-27 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-03-29 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2019-03-29 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2018-07-23 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2019-03-27 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2019-03-27 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | General Hospital | Class 1 | 880.6150 | 2023-12-26 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2020-07-20 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| HWQ | Passer | Orthopedic | Class 1 | 888.4540 | 2019-03-27 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2019-04-07 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2018-07-23 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2018-07-23 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2019-03-27 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| KCG | Dilator, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2019-03-27 |
| KQZ | Component, Traction, Non-Invasive | Orthopedic | Class 1 | 888.5890 | 2018-07-23 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2019-04-07 |
| EZO | Urethrotome | Gastroenterology, Urology | Class 2 | 876.4770 | 2019-03-29 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| KCF | Dilator, Esophageal, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-12-23 |
| CBH | Device, Fixation, Tracheal Tube | Anesthesiology | Class 1 | 868.5770 | 2019-03-27 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 2018-07-23 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2025-12-23 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2025-02-12 |
| KAP | Curette, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| JZD | Snare, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| KAO | Curette, Ethmoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2018-07-23 |
| GAH | Stylet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-23 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| KYG | Device, Irrigation, Ocular Surgery | Ophthalmic | Class 1 | 886.4360 | 2025-12-23 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2018-07-23 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2018-07-23 |
| KCP | Syringe, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2018-07-23 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-05-06 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| FFN | Clamp, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2019-03-27 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2018-07-23 |
| KAJ | Mobilizer, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| HWI | Corkscrew | Orthopedic | Class 1 | 888.4540 | 2019-03-27 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2015-03-08 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2018-07-23 |
| HNX | Depressor, Orbital | Ophthalmic | Class 1 | 886.4350 | 2019-03-27 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| HWO | Skid, Bone | Orthopedic | Class 1 | 888.4540 | 2019-03-27 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2023-12-26 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| KAS | Knife, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| HCD | Cannula, Ventricular | Neurology | Class 1 | 882.4060 | 2019-03-27 |
| KTF | Punch, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| DWP | Dilator, Vessel, Surgical | Cardiovascular | Class 2 | 870.4475 | 2025-02-12 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-23 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-23 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2019-03-29 |
| HNJ | Punch, Corneo-Scleral | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| JYE | Chisel, Middle-Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2015-03-08 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2019-04-07 |
| HRH | Trephine, Manual, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2019-03-27 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| FXE | Speculum, Non-Illuminated | General, Plastic Surgery | Class 1 | 878.1800 | 2018-07-23 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2025-12-23 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2019-03-27 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | Gastroenterology, Urology | Class 1 | 876.5090 | 2019-03-27 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| KQW | Goniometer, Nonpowered | Orthopedic | Class 1 | 888.1520 | 2019-03-27 |
| EQH | Source, Carrier, Fiberoptic Light | Ear, Nose, Throat | Class 1 | 874.4350 | 2019-03-27 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2019-03-27 |
| HSO | Saw | General, Plastic Surgery | Class 1 | 878.4800 | 2019-03-27 |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2019-03-27 |
| NNR | Block, Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2019-03-27 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2019-03-27 |
| JET | Pick, Massaging | Dental | Class 1 | 872.6650 | 2019-03-27 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2020-01-02 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2018-07-23 |
| JYH | Excavator, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| OHW | Burr, Corneal, Battery Powered, Rust Ring Removal | Ophthalmic | Class 1 | 886.4070 | 2019-03-27 |
| HDM | Packer, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2025-12-23 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2015-03-08 |
| FHL | Scoop | Gastroenterology, Urology | Class 1 | 876.4730 | 2018-07-23 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| HNA | Spud, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| HTT | Burr, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2025-12-23 |
| FTX | Mirror, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-23 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 2019-04-07 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2019-04-07 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2019-03-27 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2023-12-26 |
| EIE | Dam, Rubber | Dental | Class 1 | 872.6300 | 2020-04-10 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2018-07-23 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2015-03-08 |
| JYZ | Rod, Measuring Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2015-05-07 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2023-12-26 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2019-03-27 |
| HCH | Clip, Aneurysm | Neurology | Class 2 | 882.5200 | 2023-12-26 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2019-03-27 |
| FZQ | Clip, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4320 | 2019-03-27 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 2020-04-10 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| JYK | Holder, Ear Speculum | General, Plastic Surgery | Class 1 | 878.1800 | 2025-12-23 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2019-03-27 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-03-29 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2019-03-29 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2018-07-23 |
| IRA | Hand, External Limb Component, Mechanical | Physical Medicine | Class 1 | 890.3420 | 2019-03-27 |
| HNB | Spoon, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2019-03-27 |
| KBR | Needle, Tonsil Suturing | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| HOD | Clamp, Eyelid, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2018-07-23 |
| EYR | Tourniquet, Gastro-Urology | General, Plastic Surgery | Class 1 | 878.5900 | 2019-09-10 |
| GFD | Dermatome | General, Plastic Surgery | Class 1 | 878.4820 | 2019-03-27 |
| EXX | Probe, Rectal, Non-Powered | Gastroenterology, Urology | Class 1 | 876.4730 | 2019-03-27 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2019-03-27 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| EJG | Forceps, Rubber Dam Clamp | Dental | Class 1 | 872.6300 | 2020-04-10 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2019-04-07 |
| EIL | Gauge, Depth, Instrument, Dental | Dental | Class 1 | 872.4565 | 2025-12-23 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| KTZ | Caliper | Orthopedic | Class 1 | 888.4150 | 2018-07-23 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2018-07-23 |
| KDG | Chisel (Osteotome) | General, Plastic Surgery | Class 1 | 878.4820 | 2019-03-27 |
| GCC | Dilator, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2019-03-27 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2018-07-23 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| EKR | Plugger, Root Canal, Endodontic | Dental | Class 1 | 872.4565 | 2019-03-27 |
| KBH | Adenotome | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2019-03-29 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2019-03-29 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2015-03-08 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| JYJ | Gauge, Measuring | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| HNE | Snare, Enucleating | Ophthalmic | Class 1 | 886.4350 | 2019-03-27 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2019-03-27 |
| HWK | Trephine | Orthopedic | Class 1 | 888.4540 | 2018-07-23 |
| BWB | Forceps, Tube Introduction | Anesthesiology | Class 1 | 868.5780 | 2019-03-27 |
| EYA | Stylet, Ureteral | Gastroenterology, Urology | Class 1 | 876.5130 | 2019-03-27 |
| KBS | Punch, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| EME | Punch, Biopsy, Surgical | Dental | Class 1 | 872.4565 | 2026-01-29 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2019-03-28 |
| HBD | Handpiece (Brace), Drill | Neurology | Class 1 | 882.4325 | 2019-03-27 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2018-07-23 |
| EKJ | Burnisher, Operative | Dental | Class 1 | 872.4565 | 2019-03-27 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-23 |
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2019-03-27 |
| MXY | Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | Ophthalmic | Class 1 | 886.4350 | 2018-07-23 |
| HDE | Hook, Fibroid, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4520 | 2019-03-27 |
| EKH | Carver, Dental Amalgam, Operative | Dental | Class 1 | 872.4565 | 2020-04-10 |
| DWP | Dilator, Vessel, Surgical | Cardiovascular | Class 2 | 870.4475 | 2019-03-29 |
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | Obstetrics/Gynecology | Class 1 | 884.4530 | 2019-03-27 |
| HBT | Applier, Hemostatic Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| KAW | Punch, Antrum | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-03-27 |
| HNK | Probe, Trabeculotomy | Ophthalmic | Class 1 | 886.4350 | 2019-03-27 |
| KAN | Chisel, Nasal | General, Plastic Surgery | Class 1 | 878.4800 | 2019-03-27 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2018-07-23 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-23 |
| JOK | Scissors, Medical, Disposable | General Hospital | Class 1 | 880.6820 | 2025-12-23 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2018-07-23 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2018-07-23 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-23 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K851721 | Artiberia | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | 1985-07-02 |
| K914997 | Conmedcorp | ASP-IRRATOR | 1992-01-07 |
| K153773 | Olympus Medical Systems Corp. | Disposal Lens Cleaning Sheath | 2016-11-22 |
| K940141 | Micro-Medical Devices, Inc. | LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH | 1994-05-19 |
| K933812 | Advanced Surgical, Inc. | ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES | 1993-12-13 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures. |
| Z-0028-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures. |
| Z-0029-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled
(2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures. |
| 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-0011-2019 | Ellex iScience, Inc. | 1 | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1421879 | PHOENIX INSTRUMENTS, INC. | Lisle, IL, US |
| 1646747 | WEXLER SURGICAL, INC. | HOUSTON, TX, US |
| 3030451558 | BIS MASTERMED | Kosice Kosicky, SK |
| 3003951061 | M/S TARUN ENTERPRISES | Prayagraj, Uttar Pradesh, IN |
| 3007840839 | HOLGER BUMUELLER LLC | Rutherfordton, NC, US |
3008770252 when referencing this establishment in official correspondence.