FDA Device Registration & Listing · Saint Louis, MO, US · Registration 1926681
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EPW | Support, Head, Surgical, Ent | General, Plastic Surgery | Class 1 | 878.4950 | 2018-09-24 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2002-03-18 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2002-03-18 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 1982-10-29 |
| KTF | Punch, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-06-10 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2015-09-16 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2015-09-11 |
| FCT | Headlight, Fiberoptic Focusing | Ophthalmic | Class 2 | 886.4335 | 2005-10-28 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2005-10-07 |
| HKM | Retinoscope, Battery-Powered | Ophthalmic | Class 1 | 886.1780 | 2000-11-29 |
| BRW | Protector, Dental | Anesthesiology | Class 1 | 868.5820 | 2020-02-28 |
| EPN | Pump, Nebulizer, Manual | Ear, Nose, Throat | Class 1 | 874.5220 | 2018-09-21 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| KBP | Hook, Tonsil Suturing | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-09-11 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2018-09-24 |
| EIB | Syringe, Irrigating (Dental) | Dental | Class 1 | 872.4565 | 2007-12-21 |
| ETF | Unit, Examining/Treatment, Ent | Ear, Nose, Throat | Class 1 | 874.5300 | 1984-04-10 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2005-10-07 |
| FLE | Sterilizer, Steam | General Hospital | Class 2 | 880.6880 | 2007-11-08 |
| HRH | Trephine, Manual, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1982-10-29 |
| NNQ | Forceps, Wire Closure, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2015-09-16 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1982-10-29 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2015-09-16 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| KBE | Snare, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-03-18 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1982-10-29 |
| KAO | Curette, Ethmoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-06-10 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2018-09-24 |
| KAP | Curette, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| CBC | Bottle, Collection And Trap, Breathing System (Uncalibrated) | General Hospital | Class 2 | 880.6740 | 2005-10-07 |
| FZK | Chair, Surgical, Non-Electrical | General, Plastic Surgery | Class 1 | 878.4950 | 2020-02-28 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2015-09-16 |
| JZE | Spoon, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2015-09-15 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-06-10 |
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | Class 2 | 880.6740 | 2018-09-21 |
| HNY | Cystotome | Ophthalmic | Class 1 | 886.4350 | 2016-06-10 |
| JYA | Scissors, Wire Cutting, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2002-03-18 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| EQH | Source, Carrier, Fiberoptic Light | Ear, Nose, Throat | Class 1 | 874.4350 | 2000-11-29 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 1982-10-29 |
| JYE | Chisel, Middle-Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-03-18 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2015-09-16 |
| LCC | Applicator, Ocular Pressure | Ophthalmic | Class 2 | 886.4610 | 2005-10-07 |
| KCA | Tonsillectome | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| GBB | Chair, Surgical, Ac-Powered | General, Plastic Surgery | Class 1 | 878.4960 | 1994-05-13 |
| LFB | Button, Nasal Septal | Unknown | Class U | N/A | 2020-03-19 |
| KAW | Punch, Antrum | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-06-10 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-09-24 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2020-02-28 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-06-10 |
| DQD | Stethoscope, Electronic | Cardiovascular | Class 2 | 870.1875 | 2019-02-27 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 1982-10-29 |
| EMK | Curette, Surgical, Dental | Dental | Class 1 | 872.4565 | 2016-12-21 |
| KBM | Dissector, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1982-10-29 |
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2015-09-16 |
| JYC | Cannula, Ear | General, Plastic Surgery | Class 1 | 878.4800 | 2015-09-15 |
| KCP | Syringe, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 1983-10-29 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1982-10-29 |
| HLR | Keratoscope, Battery-Powered | Ophthalmic | Class 1 | 886.1350 | 2005-10-07 |
| KCM | Dropper, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2020-02-28 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 1982-10-29 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-08-09 |
| EQJ | Bur, Ear, Nose And Throat | Ear, Nose, Throat | Class 1 | 874.4140 | 1982-10-29 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Ear, Nose, Throat | Class 2 | 874.4250 | 2007-11-08 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2005-10-07 |
| KCL | Blower, Powder, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2018-09-21 |
| PJZ | Camera, Ophthalmic, General-Use | Ophthalmic | Class 2 | 886.1120 | 2019-08-15 |
| KBC | Saw, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 2000-11-29 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-06-10 |
| ERA | Otoscope | Ear, Nose, Throat | Class 1 | 874.4770 | 1982-10-29 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | Class 1 | 878.4160 | 2019-04-15 |
| FXQ | Lens, Camera, Surgical | General, Plastic Surgery | Class 1 | 878.4160 | 2020-02-28 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2020-02-28 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2015-09-16 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | Class 2 | 880.6740 | 2018-06-25 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2000-11-29 |
| HPP | Headlamp, Operating, Battery-Operated | Ophthalmic | Class 1 | 886.4335 | 2007-12-21 |
| LYA | Splint, Intranasal Septal | Ear, Nose, Throat | Class 1 | 874.4780 | 2006-12-21 |
| HMQ | Marker, Sclera | Ophthalmic | Class 1 | 886.4570 | 1982-10-29 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | General Hospital | Class 1 | 880.6150 | 2005-10-07 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2000-11-29 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | Obstetrics/Gynecology | Class 1 | 884.4520 | 2015-09-16 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1982-10-29 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2007-11-08 |
| LWF | Dilator, Nasal | Ear, Nose, Throat | Class 1 | 874.3900 | 2018-09-24 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2002-03-18 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | Ophthalmic | Class 2 | 886.1850 | 2019-02-27 |
| HKI | Camera, Ophthalmic, Ac-Powered | Ophthalmic | Class 2 | 886.1120 | 2019-02-27 |
| LRJ | Disinfectant, Medical Devices | General Hospital | Class 1 | 880.6890 | 2000-11-29 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 1982-10-29 |
| NNR | Block, Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2015-09-16 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-09-15 |
| HBM | Headrest, Neurosurgical | Neurology | Class 1 | 882.4440 | 2007-12-21 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 1982-10-29 |
| HKX | Tonometer, Ac-Powered | Ophthalmic | Class 2 | 886.1930 | 2020-02-28 |
| HKI | Camera, Ophthalmic, Ac-Powered | Ophthalmic | Class 2 | 886.1120 | 2018-12-27 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 1982-10-29 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1982-10-29 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| JYM | Inserter, Myringotomy Tube | Ear, Nose, Throat | Class 1 | 874.4420 | 2006-10-04 |
| KAM | Cannula, Sinus | General, Plastic Surgery | Class 1 | 878.4800 | 1982-10-29 |
| EKR | Plugger, Root Canal, Endodontic | Dental | Class 1 | 872.4565 | 2000-11-29 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2020-02-28 |
| FXR | Holder, Camera, Surgical | General, Plastic Surgery | Class 1 | 878.4160 | 2020-02-28 |
| GBC | Lamp, Surgical, Incandescent | General, Plastic Surgery | Class 2 | 878.4580 | 2007-11-08 |
| KMN | Chair And Table, Medical | General Hospital | Class 1 | 880.6140 | 2000-11-29 |
| JYH | Excavator, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2002-03-18 |
| EPT | Microscope, Surgical | General, Plastic Surgery | Class 1 | 878.4700 | 1984-04-10 |
| HJJ | Lens, Fresnel, Flexible, Diagnostic | Ophthalmic | Class 1 | 886.1390 | 2005-10-28 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2015-09-16 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2015-09-16 |
| KAS | Knife, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1982-10-29 |
| KAY | Punch, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| JOK | Scissors, Medical, Disposable | General Hospital | Class 1 | 880.6820 | 1982-10-29 |
| JPW | Pump, Nebulizer, Electrically Powered | Ear, Nose, Throat | Class 1 | 874.5220 | 2018-09-21 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1982-10-29 |
| EQN | Laryngoscope, Nasopharyngoscope | Ear, Nose, Throat | Class 2 | 874.4760 | 1988-10-18 |
| MML | Weights, Eyelid, External | Ophthalmic | Class 2 | 886.5700 | 2005-10-07 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| 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 |
| K021223 | Sauter AG | BELIMED STEAM STERILIZER, MODEL TOP 5000 | 2002-06-26 |
| K050263 | M.O. Com S.R.L. | MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU | 2006-11-21 |
| K922626 | Andronic Devices, Ltd. | ADEPT INSTRUMENT POSITIONING ACCESSORY | 1992-10-19 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0144-2024 | Covidien | 1 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 |
| Z-0168-2024 | Covidien | 1 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only |
| Z-0169-2024 | Covidien | 1 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only |
| Z-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Z-0013-2019 | COVIDIEN LLC | 1 | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332
Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3003790304 | GYRUS ACMI, INC. | Westborough, MA, US |
| 1928237 | MIDWEST STERILIZATION CORP. | JACKSON, MO, US |
| 3018094310 | Medtronic Engineering and Innovation Center (MEIC) | Hyderabad Telangana, IN |
| 1045254 | MEDTRONIC XOMED, INC. | Jacksonville, FL, US |
| 3011050570 | Gyrus ACMI, Inc. | Brooklyn Park, MN, US |
1926681 when referencing this establishment in official correspondence.