FDA Device Registration & Listing · Schaumburg, IL, US · Registration 3004215117
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2016-11-17 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-21 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2018-05-30 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2016-11-21 |
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | Class 1 | 872.4565 | 2019-10-03 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-07-10 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-07-05 |
| GAI | Stripper, Vein, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2018-05-30 |
| ILH | Splint, Hand, And Components | Physical Medicine | Class 1 | 890.3475 | 2016-11-17 |
| DWH | Blade, Saw, Surgical, Cardiovascular | General, Plastic Surgery | Class 1 | 878.4820 | 2020-02-04 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2016-11-17 |
| HFX | Clamp, Circumcision | Obstetrics/Gynecology | Class 2 | 884.4530 | 2026-02-13 |
| HTP | File | Orthopedic | Class 1 | 888.4540 | 2016-11-21 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2016-11-16 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-11-16 |
| FXM | Camera, Still, Endoscopic | General, Plastic Surgery | Class 1 | 878.4160 | 2023-06-25 |
| HCZ | Forceps, Surgical, Gynecological | Obstetrics/Gynecology | Class 2 | 884.4530 | 2016-09-21 |
| EKT | Curette, Endodontic | Dental | Class 1 | 872.4565 | 2016-11-17 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-21 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| HWP | Punch, Femoral Neck | Orthopedic | Class 1 | 888.4540 | 2019-12-10 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-21 |
| HNB | Spoon, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-05-30 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-21 |
| LWH | Counter, Sponge, Surgical | General Hospital | Class 1 | 880.2740 | 2026-02-13 |
| GEO | File, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-17 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-17 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2016-11-17 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2016-11-16 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2018-04-04 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2016-05-09 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2018-02-19 |
| HAE | Rongeur, Manual | Neurology | Class 2 | 882.4840 | 2016-09-21 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-16 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-17 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2019-05-16 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-21 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2016-09-21 |
| FBX | Sound, Urethral, Metal Or Plastic | Gastroenterology, Urology | Class 1 | 876.5520 | 2018-05-30 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2016-09-21 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| FAX | Bougie, Urological | Gastroenterology, Urology | Class 1 | 876.5520 | 2016-11-17 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2016-11-16 |
| HAE | Rongeur, Manual | Neurology | Class 2 | 882.4840 | 2019-10-24 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2016-11-21 |
| GCZ | Retainer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2017-02-03 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-17 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2017-02-03 |
| HRH | Trephine, Manual, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-11-16 |
| KAQ | Gouge, Nasal, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-21 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-04-19 |
| FGN | Retractor, Non-Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-11-17 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-17 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2016-11-16 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-06-26 |
| HOB | Clamp, Muscle, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-11-17 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2018-03-28 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2018-05-30 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-11-16 |
| HWK | Trephine | Orthopedic | Class 1 | 888.4540 | 2016-11-17 |
| HNX | Depressor, Orbital | Ophthalmic | Class 1 | 886.4350 | 2016-11-17 |
| KYT | Light, Examination, Medical, Battery Powered | General Hospital | Class 1 | 880.6350 | 2018-04-19 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2016-11-16 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2019-05-07 |
| NWV | Laparoscopic Accessories, Gynecologic | Obstetrics/Gynecology | Class 1 | 884.1720 | 2018-01-17 |
| PIY | Stainless Steel Instrument, Shunt System Implantation | Neurology | Class 1 | 882.4545 | 2020-11-03 |
| HST | Apparatus, Traction, Non-Powered | Orthopedic | Class 1 | 888.5850 | 2018-05-30 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-21 |
| HNM | Needle, Ophthalmic Suturing | Ophthalmic | Class 1 | 886.4350 | 2016-11-21 |
| JYY | Rasp, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-21 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-21 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| KCG | Dilator, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-05-30 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-21 |
| KYG | Device, Irrigation, Ocular Surgery | Ophthalmic | Class 1 | 886.4360 | 2018-03-04 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2016-11-16 |
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | Obstetrics/Gynecology | Class 1 | 884.4530 | 2016-11-21 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-03-04 |
| HOZ | Sponge, Ophthalmic | Ophthalmic | Class 2 | 886.4790 | 2018-08-29 |
| NWW | Hysteroscope Accessories | Obstetrics/Gynecology | Class 1 | 884.1690 | 2018-03-04 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-21 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2016-09-21 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2020-01-02 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| HPP | Headlamp, Operating, Battery-Operated | Ophthalmic | Class 1 | 886.4335 | 2023-06-20 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-11-15 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-21 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-21 |
| FFN | Clamp, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-11-21 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2017-12-11 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2016-11-21 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-21 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-11-17 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2016-09-21 |
| HMR | Marker, Ocular | Ophthalmic | Class 1 | 886.4570 | 2016-11-16 |
| HOZ | Sponge, Ophthalmic | Ophthalmic | Class 2 | 886.4790 | 2018-05-30 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2016-11-21 |
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2026-02-13 |
| DWP | Dilator, Vessel, Surgical | Cardiovascular | Class 2 | 870.4475 | 2016-09-21 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2019-07-08 |
| FGY | Cannula, Injection | General, Plastic Surgery | Class 1 | 878.4200 | 2018-01-26 |
| FHL | Scoop | Gastroenterology, Urology | Class 1 | 876.4730 | 2018-07-25 |
| HWQ | Passer | Orthopedic | Class 1 | 888.4540 | 2016-11-21 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2016-11-17 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-16 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-05-09 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-17 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-04-19 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | Class 2 | 882.4800 | 2016-09-21 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2019-03-29 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-03-29 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-17 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2026-02-13 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2026-02-13 |
| GAL | Suture, Absorbable, Natural | General, Plastic Surgery | Class 2 | 878.4830 | 2026-02-13 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | General, Plastic Surgery | Class 2 | 878.4495 | 2026-02-13 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2026-02-13 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2026-02-13 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-21 |
| DYX | Lock, Wire, And Ligature, Intraoral | Dental | Class 2 | 872.4600 | 2018-05-30 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2016-11-17 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-11-16 |
| FZW | Expander, Surgical, Skin Graft | General, Plastic Surgery | Class 1 | 878.4800 | 2018-03-18 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-08-13 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2019-08-20 |
| GEH | Unit, Cryosurgical, Accessories | General, Plastic Surgery | Class 2 | 878.4350 | 2026-02-13 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2016-09-21 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2016-11-16 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-11-15 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-17 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-17 |
| HXR | Spatula, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2026-02-13 |
| HBT | Applier, Hemostatic Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-11 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2016-11-17 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-03-18 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-21 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-17 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2016-11-16 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 2018-07-11 |
| EJI | Syringe, Cartridge | Dental | Class 2 | 872.6770 | 2018-05-30 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-11-17 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2016-11-17 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2026-02-13 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2018-05-30 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2016-05-09 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2018-05-30 |
| FCW | Light Source, Fiberoptic, Routine | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-09-25 |
| GAH | Stylet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-21 |
| HBD | Handpiece (Brace), Drill | Neurology | Class 1 | 882.4325 | 2023-06-25 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-21 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.4150 | 2018-01-30 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-11-16 |
| KEY | Stainer, Tissue, Automated | Pathology | Class 1 | 864.3800 | 2020-02-07 |
| HHM | Sound, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2016-11-21 |
| FFD | Evacuator, Bladder, Manually Operated | Gastroenterology, Urology | Class 1 | 876.4370 | 2018-04-19 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-17 |
| HPZ | Implant, Eye Sphere | Ophthalmic | Class 2 | 886.3320 | 2018-05-30 |
| HQN | Conformer, Ophthalmic | Ophthalmic | Class 2 | 886.3130 | 2018-05-30 |
| KAO | Curette, Ethmoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-17 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2016-11-16 |
| FHN | Ligator, Hemorrhoidal | Gastroenterology, Urology | Class 2 | 876.4400 | 2016-09-21 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-16 |
| HNY | Cystotome | Ophthalmic | Class 1 | 886.4350 | 2016-11-16 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2018-05-30 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2016-11-21 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-16 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-17 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2016-11-16 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2018-05-30 |
| HDC | Tenaculum, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2018-05-30 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2018-03-26 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2018-05-30 |
| FHN | Ligator, Hemorrhoidal | Gastroenterology, Urology | Class 2 | 876.4400 | 2016-11-17 |
| EZB | Stylet For Catheter, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.5130 | 2019-12-18 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-11-16 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Neurology | Class 2 | 882.4800 | 2016-09-22 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-17 |
| JDW | Pin, Fixation, Threaded | Orthopedic | Class 2 | 888.3040 | 2016-11-17 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2016-11-17 |
| NNN | Crimper, Wire, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2016-11-17 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2016-11-21 |
| FBS | Sound, Metal, Interconnected | Gastroenterology, Urology | Class 1 | 876.4590 | 2016-11-17 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2016-11-17 |
| EKG | Condenser, Amalgam And Foil, Operative | Dental | Class 1 | 872.4565 | 2018-05-30 |
| KAN | Chisel, Nasal | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-17 |
| GEE | Brush, Biopsy, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-04-19 |
| DYC | Vectorcardiograph | Cardiovascular | Class 2 | 870.2400 | 2026-02-13 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2017-01-19 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | Neurology | Class 2 | 882.4300 | 2018-05-30 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-21 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-01-16 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-17 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-21 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-21 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-01-16 |
| GCC | Dilator, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2018-05-30 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2018-04-19 |
| HXS | Twister, Wire | Orthopedic | Class 1 | 888.4540 | 2016-11-17 |
| GGQ | Test, Prothrombin Consumption | Hematology | Class 2 | 864.7720 | 2026-02-13 |
| HNP | Introducer, Sphere | Ophthalmic | Class 1 | 886.4350 | 2016-11-17 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-16 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2017-12-11 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2017-12-11 |
| HNJ | Punch, Corneo-Scleral | Ophthalmic | Class 1 | 886.4350 | 2016-11-16 |
| HWO | Skid, Bone | Orthopedic | Class 1 | 888.4540 | 2020-02-12 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2016-11-21 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-11-17 |
| HKY | Tonometer, Manual | Ophthalmic | Class 2 | 886.1930 | 2026-02-13 |
| EQH | Source, Carrier, Fiberoptic Light | Ear, Nose, Throat | Class 1 | 874.4350 | 2019-01-30 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-11-16 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-09-21 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2016-09-21 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2016-11-21 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2016-11-17 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-11-16 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2016-11-17 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 8010372 | Instrumed GmbH dba Avalign German Specialty Instruments | TUTTLINGEN Baden-Wurttemberg, DE |
| 1527105 | AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC | Mentor, OH, US |
| 1421101 | Instrumed International Inc dba Avalign German Specialty Instruments | SCHAUMBURG, IL, US |
| 3008864603 | AVALIGN TECHNOLOGIES, Inc. | Fort Wayne, IN, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K970809 | Somnus Medical Technologies, Inc. | BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL | 1997-06-18 |
| K222793 | C.R. Bard, Inc. | WavelinQ Generator | 2022-10-17 |
| K002257 | Tecno Instruments (Pvt.) , Ltd. | TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 | 2000-10-19 |
| K193591 | Bowa-Electronics GmbH & Co. KG | ARC 400 | 2020-04-02 |
| K192128 | Sutter Medizintechnik GmbH | Sutter Arrowtip Monopolar Electrodes | 2019-10-04 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0031-06 | Rita Medical Systems | 2 | Rita Brand Habib 4X Electrosurgical Coagulator,
Catalog Number: 4401US;
Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826 |
| 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-0040-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 3mm Offset (Blue)
Catalog Number: 72201713
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1032227 | BRASSELER U.S.A. DENTAL, LLC | SAVANNAH, GA, US |
| 1836161 | ASPEN SURGICAL PRODUCTS, INC. | Caledonia, MI, US |
| 8040278 | Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, PK |
| 9681540 | ULTRA SURGICAL (PVT.) LTD | SIALKOT Punjab, PK |
| 3003956316 | COMMIC SURGICO | SIALKOT Punjab, PK |
3004215117 when referencing this establishment in official correspondence.