FDA Device Registration & Listing · Tijuana Baja California, MX · Registration 3016245399
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2025-03-04 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2020-08-07 |
| FZP | Clip, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2019-03-06 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2022-11-09 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-03-04 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2021-07-02 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2019-03-06 |
| HQC | Unit, Phacofragmentation | Ophthalmic | Class 2 | 886.4670 | 2022-04-19 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2019-03-04 |
| FZP | Clip, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2019-03-06 |
| FZP | Clip, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2026-03-20 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-02-12 |
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | Unknown | Class 3 | N/A | 2026-02-17 |
| QZI | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | Unknown | Class 3 | N/A | 2026-02-17 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Unknown | Class 3 | N/A | 2026-02-17 |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | Clinical Chemistry | Class 2 | 880.5730 | 2026-04-09 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-12-03 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2023-09-21 |
| QZI | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | Unknown | Class 3 | N/A | 2026-06-16 |
| HQC | Unit, Phacofragmentation | Ophthalmic | Class 2 | 886.4670 | 2022-03-22 |
| HQC | Unit, Phacofragmentation | Ophthalmic | Class 2 | 886.4670 | 2022-03-22 |
| HGI | Electrocautery, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.4120 | 2020-06-16 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2020-06-16 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2020-06-16 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-11-06 |
| HQC | Unit, Phacofragmentation | Ophthalmic | Class 2 | 886.4670 | 2022-03-22 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2019-03-04 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | Class 2 | 870.3300 | 2023-11-29 |
| HCG | Device, Neurovascular Embolization | Neurology | Class 2 | 882.5950 | 2023-11-29 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2019-03-04 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2024-12-12 |
| FZP | Clip, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2019-03-04 |
| PKU | Insulin Pump Secondary Display | Clinical Chemistry | Class 2 | 862.1350 | 2025-12-12 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2024-02-08 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | Class 2 | 870.3300 | 2024-03-01 |
| HCG | Device, Neurovascular Embolization | Neurology | Class 2 | 882.5950 | 2024-03-01 |
No official correspondent registered.
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3015410662 | Jabil Inc. (Wilson Drive) | W Chester, PA, US |
| 3011246727 | Jabil Circuit Sdn. Bhd. | Bayan Lepas Pulau Pinang, MY |
| 3003512059 | NYPRO DR, LLC (Bldg 11) | Haina San Cristobal, DO |
| 3004730544 | NYPRO DR, LLC (Building 52) | Haina San Cristobal, DO |
| 1424235 | Nypro Inc. (Chicago) | GURNEE, IL, 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-0332-2022 | Covidien Llc | U | Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status
Item Code: CBCA |
| 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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007353760 | ENERGIST LIMITED | Swansea, GB |
| 3005064998 | RDI INC. | Mount Kisco, NY, US |
| 3020623326 | TRIWORKS GROUP S.R.L. | Palata Campobasso, IT |
| 3012616488 | BRERA MEDICAL INCORPORATED | Northborough, MA, US |
| 3012940012 | Sutter Medical Technologies USA Inc. | Alpharetta, GA, US |
3016245399 when referencing this establishment in official correspondence.