FDA Device Registration & Listing · Red Bud, IL, US · Registration 3007583964
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| NJZ | Extractor, Vein | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-03 |
| JYQ | Loop, Wire | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-01-03 |
| HNY | Cystotome | Ophthalmic | Class 1 | 886.4350 | 2013-01-03 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-01-03 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2012-11-01 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-03 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-02-02 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-01-03 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-01-03 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-02-02 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-02-02 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-02-02 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-02-02 |
| HNH | Ring, Ophthalmic (Flieringa) | Ophthalmic | Class 1 | 886.4350 | 2006-02-02 |
| GAI | Stripper, Vein, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-03 |
| HNA | Spud, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2017-08-25 |
| HNB | Spoon, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2017-08-25 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2025-12-09 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2006-02-02 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-02-02 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-01-03 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-03 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-02-02 |
| HOB | Clamp, Muscle, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2017-10-20 |
| HOD | Clamp, Eyelid, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2017-10-20 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-01-03 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2006-02-02 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1119279 | Bausch & Lomb Incorporated | CLEARWATER, FL, US |
| 1920664 | Bausch & Lomb Incorporated | Saint Louis, MO, US |
| 1032500 | Bausch & Lomb Incorporated | GREENVILLE, SC, US |
| 1281950 | Bausch & Lomb Incorporated | WILMINGTON, MA, US |
| 1315522 | Bausch & Lomb Incorporated | Lancaster, NY, US |
| 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-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 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3003807268 | HIVE INTERNATIONAL PVT LTD. | Sialkot Punjab, PK |
| 3007597038 | SURGICON PVT LTD | Sialkot Punjab, PK |
| 3013946322 | NEXTCON INTERNATIONAL | Sialkot Punjab, PK |
| 8010697 | GEISTER MEDIZINTECHNIK GMBH | TUTTLINGEN Baden-Wurttemberg, DE |
| 3005440795 | XINHUA SURGICAL INSTRUMENT CO. LTD. | ZIBO Shandong, CN |
3007583964 when referencing this establishment in official correspondence.