FDA Device Registration & Listing · Indianapolis, IN, US · Registration 3004598644
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2016-06-14 |
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) | Orthopedic | Class 1 | 888.4200 | 2018-03-27 |
| NSC | Injector, Pen | General Hospital | Class 2 | 880.5860 | 2022-09-12 |
| BYZ | Trap, Sterile Specimen | General Hospital | Class 2 | 880.6740 | 2016-06-14 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-06-14 |
| PDQ | Neurosurgical Nerve Locator | Ear, Nose, Throat | Class 2 | 874.1820 | 2020-07-06 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2020-07-06 |
| HBB | Motor, Drill, Pneumatic | Neurology | Class 2 | 882.4370 | 2018-04-18 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | General, Plastic Surgery | Class 2 | 878.4780 | 2026-03-26 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2017-02-01 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2018-03-27 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | Class 2 | 888.3027 | 2018-03-27 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2025-12-09 |
| SFQ | Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision | General, Plastic Surgery | Class 2 | 878.4400 | 2025-12-09 |
| KNW | Instrument, Biopsy | Gastroenterology, Urology | Class 2 | 876.1075 | 2016-06-14 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2021-01-05 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2024-12-20 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3027241818 | Kimball Electronics - Mexico SA de CV | Reynosa Tamaulipas, MX |
| 3008253300 | Kimball Solutions Jasper, Inc. | Jasper, IN, US |
| 3008058135 | Kimball Electronics Poland Sp.z o.o | Tarnowo Podgorne Wielkopolskie, PL |
| 3003660459 | Kimball Electronics - Thailand LTD | Thungsukhla Sriracha Chon Buri, TH |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| 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 |
| K254228 | Karl Storz SE & CO. KG | KARL STORZ Trocars with Valve Seals | 2026-05-11 |
| 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-0023-2020 | Stryker Instruments Div. of Stryker Corporation | 2 | C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329
Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery. |
| Z-0024-2020 | Stryker Instruments Div. of Stryker Corporation | 2 | C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319
Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9680454 | EMPRESAS IAI S DE RL DE C.V. | H. MATAMOROS Tamaulipas, MX |
| 3010227982 | Tianjin Zhengtian Medical Instrument Co., Ltd. | Tianjin, CN |
| 3016871880 | PRIMEX DESIGN & FABRICATION | Richmond, IN, US |
| 3005360866 | QEL DOMINICANA S.A. | ESPERANZA Valverde, DO |
| 3010601984 | Jiangsu Haize Medical Scientific Development Co.,Ltd. | Wuxi Jiangsu, CN |
3004598644 when referencing this establishment in official correspondence.