FDA Device Registration & Listing · Lisle, IL, US · Registration 1421879
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HDE | Hook, Fibroid, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-02-01 |
| FXE | Speculum, Non-Illuminated | General, Plastic Surgery | Class 1 | 878.1800 | 2019-08-23 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| KAS | Knife, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2020-11-06 |
| KQZ | Component, Traction, Non-Invasive | Orthopedic | Class 1 | 888.5890 | 2020-11-06 |
| HGC | Clamp, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-02-01 |
| HNH | Ring, Ophthalmic (Flieringa) | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2019-08-26 |
| FFP | Dilator, Rectal | Gastroenterology, Urology | Class 1 | 876.5450 | 2013-01-31 |
| HWI | Corkscrew | Orthopedic | Class 1 | 888.4540 | 2019-08-23 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2013-01-30 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2013-02-01 |
| KCG | Dilator, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-06 |
| GEJ | Carrier, Ligature | General, Plastic Surgery | Class 1 | 878.4800 | 2019-08-23 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 2013-01-30 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2013-01-30 |
| KTF | Punch, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-02 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2013-02-01 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-02-02 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| KDG | Chisel (Osteotome) | General, Plastic Surgery | Class 1 | 878.4820 | 2013-02-01 |
| JET | Pick, Massaging | Dental | Class 1 | 872.6650 | 2019-08-23 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2019-08-22 |
| FDG | Retractor, Fiberoptic | Gastroenterology, Urology | Class 1 | 876.4530 | 2019-08-22 |
| KCP | Syringe, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2013-02-01 |
| GCC | Dilator, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2013-01-31 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2013-02-06 |
| HER | Pelvimeter, External | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-02-01 |
| IRA | Hand, External Limb Component, Mechanical | Physical Medicine | Class 1 | 890.3420 | 2019-08-26 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2013-02-01 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2013-02-01 |
| HRH | Trephine, Manual, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2020-11-06 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2013-02-06 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| FHB | Hook, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-01-31 |
| HNA | Spud, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2019-08-23 |
| FHL | Scoop | Gastroenterology, Urology | Class 1 | 876.4730 | 2019-08-23 |
| KBC | Saw, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-06 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2013-01-31 |
| EKE | Curette, Operative | Dental | Class 1 | 872.4565 | 2013-02-06 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2013-02-01 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-01-31 |
| DWP | Dilator, Vessel, Surgical | Cardiovascular | Class 2 | 870.4475 | 2020-11-11 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2019-08-23 |
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | Class 1 | 872.4565 | 2019-10-08 |
| KAQ | Gouge, Nasal, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| HSO | Saw | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-01 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-06 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| KAN | Chisel, Nasal | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-01 |
| HWK | Trephine | Orthopedic | Class 1 | 888.4540 | 2013-02-01 |
| JYJ | Gauge, Measuring | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-11-06 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2019-08-23 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2013-02-01 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-02-01 |
| HDM | Packer, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-02-06 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| GEC | Brush, Scrub, Operating-Room | General, Plastic Surgery | Class 1 | 878.4800 | 2019-08-23 |
| JYE | Chisel, Middle-Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-08-23 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2013-02-06 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-02 |
| HBD | Handpiece (Brace), Drill | Neurology | Class 1 | 882.4325 | 2013-02-01 |
| EIK | Carver, Wax, Dental | Dental | Class 1 | 872.4565 | 2019-08-22 |
| NNR | Block, Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2013-02-02 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-11-06 |
| KBH | Adenotome | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | Obstetrics/Gynecology | Class 1 | 884.4530 | 2013-02-01 |
| FZQ | Clip, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4320 | 2019-08-23 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2013-01-31 |
| JYC | Cannula, Ear | General, Plastic Surgery | Class 1 | 878.4800 | 2020-11-06 |
| KCF | Dilator, Esophageal, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| HXY | Brace, Drill | Orthopedic | Class 1 | 888.4540 | 2019-08-23 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2019-08-23 |
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | Class 1 | 878.5900 | 2013-01-31 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-02-01 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2020-11-09 |
| FTX | Mirror, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-06 |
| JYF | Clamp, Ossicle Holding | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-08-23 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2020-11-06 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | Class 1 | 878.4950 | 2013-02-06 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-01 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | Gastroenterology, Urology | Class 1 | 876.5090 | 2013-01-30 |
| HOF | Burr, Corneal, Manual | Ophthalmic | Class 1 | 886.4350 | 2020-11-06 |
| EIL | Gauge, Depth, Instrument, Dental | Dental | Class 1 | 872.4565 | 2020-11-06 |
| FGN | Retractor, Non-Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-01-31 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2013-02-06 |
| HNJ | Punch, Corneo-Scleral | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| HYA | Forceps, Wire Holding | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-06 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2020-11-06 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| KTZ | Caliper | Orthopedic | Class 1 | 888.4150 | 2013-02-02 |
| GAI | Stripper, Vein, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2019-08-23 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2020-11-18 |
| HTP | File | Orthopedic | Class 1 | 888.4540 | 2013-02-01 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2013-01-30 |
| HCD | Cannula, Ventricular | Neurology | Class 1 | 882.4060 | 2019-08-23 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| KBS | Punch, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| GEO | File, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-06 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-01 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-02-06 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2020-11-11 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| EXX | Probe, Rectal, Non-Powered | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-01-30 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2013-01-30 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2020-11-06 |
| FHN | Ligator, Hemorrhoidal | Gastroenterology, Urology | Class 2 | 876.4400 | 2020-11-11 |
| JYH | Excavator, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-11-06 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 2020-11-09 |
| EJG | Forceps, Rubber Dam Clamp | Dental | Class 1 | 872.6300 | 2013-02-06 |
| JYY | Rasp, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-02 |
| EMR | File, Periodontic | Dental | Class 1 | 872.4565 | 2020-11-06 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-02-02 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| FBX | Sound, Urethral, Metal Or Plastic | Gastroenterology, Urology | Class 1 | 876.5520 | 2013-01-30 |
| EEF | Clamp, Rubber Dam | Dental | Class 1 | 872.6300 | 2013-02-06 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-11-06 |
| BWB | Forceps, Tube Introduction | Anesthesiology | Class 1 | 868.5780 | 2013-01-30 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2020-11-06 |
| EYA | Stylet, Ureteral | Gastroenterology, Urology | Class 1 | 876.5130 | 2013-01-30 |
| HNB | Spoon, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2020-11-06 |
| HNM | Needle, Ophthalmic Suturing | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2013-02-01 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2013-02-06 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2020-11-11 |
| ILH | Splint, Hand, And Components | Physical Medicine | Class 1 | 890.3475 | 2013-02-01 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2019-08-22 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-01 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2020-11-11 |
| JYK | Holder, Ear Speculum | General, Plastic Surgery | Class 1 | 878.1800 | 2020-11-06 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| HNP | Introducer, Sphere | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2013-02-02 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 2019-08-23 |
| JYP | Knife, Myringotomy | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-01-30 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2013-02-01 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2013-02-01 |
| HDA | Forceps, Obstetrical | Obstetrics/Gynecology | Class 2 | 884.4400 | 2020-11-11 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2019-08-22 |
| OHW | Burr, Corneal, Battery Powered, Rust Ring Removal | Ophthalmic | Class 1 | 886.4070 | 2020-11-09 |
| FHA | Clamp, Penile | Gastroenterology, Urology | Class 1 | 876.5160 | 2013-01-31 |
| GAH | Stylet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-06 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2013-02-01 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| HMR | Marker, Ocular | Ophthalmic | Class 1 | 886.4570 | 2013-02-01 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| KAR | Irrigator, Sinus | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-30 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-02 |
| KQW | Goniometer, Nonpowered | Orthopedic | Class 1 | 888.1520 | 2019-08-23 |
| KAC | Tube, Laryngectomy | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-11-09 |
| CCX | Support, Patient Position | Anesthesiology | Class 1 | 868.6820 | 2020-09-23 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2020-11-06 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2013-02-01 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2013-02-01 |
| GFD | Dermatome | General, Plastic Surgery | Class 1 | 878.4820 | 2013-01-31 |
| HNE | Snare, Enucleating | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| KAP | Curette, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| JOK | Scissors, Medical, Disposable | General Hospital | Class 1 | 880.6820 | 2013-02-06 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-02-01 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-31 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2013-02-01 |
| KAW | Punch, Antrum | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| HNK | Probe, Trabeculotomy | Ophthalmic | Class 1 | 886.4350 | 2019-08-23 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2013-02-01 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-02 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-02 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-01 |
| EQH | Source, Carrier, Fiberoptic Light | Ear, Nose, Throat | Class 1 | 874.4350 | 2019-08-22 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2013-02-01 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 2013-01-31 |
| GFF | Bur, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4820 | 2013-02-06 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| EKJ | Burnisher, Operative | Dental | Class 1 | 872.4565 | 2019-08-22 |
| KBR | Needle, Tonsil Suturing | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-02-01 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2020-11-06 |
| MXY | Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | Ophthalmic | Class 1 | 886.4350 | 2019-08-23 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2019-08-22 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-01-31 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-01 |
| FFN | Clamp, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2019-08-23 |
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-02-01 |
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | Class 2 | 880.6740 | 2013-02-06 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2013-02-01 |
No US Agent registered (Local establishment).
| 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 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| K894785 | Fdt Precision Machine Co., Inc. | SURGICAL CHISEL/OSTEOTOME | 1989-08-18 |
| K821629 | Moyco Industries, Inc. | FIXIDENT | 1982-06-14 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| 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-0036-2010 | Alphatec Spine, Inc. | 1 | ROC Lumbar bolt caddy, Part Number: 81997-01-05.
Sterilization container for ROC bolts/screws. Product is used to contain spinal implants. |
| Z-0021-2015 | Biomet, Inc. | 1 | Compress Face Reamer
Product Usage:
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma. |
| 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 |
|---|---|---|
| 1417592 | MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, US |
| 8030607 | Industrias Apson S.A de C.V | AGUA PRIETA Sonora, MX |
| 3023657851 | INKA SURGICAL INSTRUMENTS | Jandakot Western Australia, AU |
| 2529846 | MED SAVER, INC. | PHOENIXVILLE, PA, US |
| 3007773213 | SITEC (PVT.) LTD. | SIALKOT Punjab, PK |
1421879 when referencing this establishment in official correspondence.