FDA Device Registration & Listing · Dongguan Guangdong, CN · Registration 3010305275
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | Anesthesiology | Class 1 | 868.5770 | 2019-12-18 |
| OFR | Tracheobronchial Suction Catheter Kit | Anesthesiology | Class 1 | 868.6810 | 2025-07-08 |
| PXV | General Purpose Instrument Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2025-01-22 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2017-05-15 |
| MMP | Cover, Barrier, Protective | General, Plastic Surgery | Class 2 | 878.4370 | 2013-01-30 |
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | Class 1 | 878.4018 | 2017-05-16 |
| CCX | Support, Patient Position | Anesthesiology | Class 1 | 868.6820 | 2017-08-23 |
| KKX | Drape, Surgical, Antimicrobial | General, Plastic Surgery | Class 2 | 878.4370 | 2013-01-30 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2013-01-30 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2013-12-05 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-05-15 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2017-05-15 |
| EXB | Collector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2019-03-22 |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Pathology | Class 1 | 864.3250 | 2013-11-26 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2024-04-12 |
| NNI | Container, Specimen, Non-Sterile | Pathology | Class 1 | 864.3250 | 2024-11-04 |
| FPY | Sheet, Burn | General Hospital | Class 1 | 880.5180 | 2021-04-08 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | Gastroenterology, Urology | Class 1 | 876.5250 | 2013-01-30 |
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | Class 1 | 868.6810 | 2018-06-22 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2013-01-30 |
| LWH | Counter, Sponge, Surgical | General Hospital | Class 1 | 880.2740 | 2015-07-22 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | Class 2 | 876.5250 | 2016-03-07 |
| LHC | Warmer, Irrigation Solution | Physical Medicine | Class 1 | 890.5950 | 2025-02-19 |
| BTK | Strap, Head, Gas Mask | Anesthesiology | Class 1 | 868.5560 | 2019-01-09 |
| FTA | Light, Surgical, Accessories | General, Plastic Surgery | Class 2 | 878.4580 | 2022-08-05 |
| IKX | Aid, Transfer | Physical Medicine | Class 1 | 890.5050 | 2015-03-10 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2020-05-27 |
| 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-0013-2012 | Convatec Inc. | 1 | Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm)
Required for application to a patient immediately after ostomy surgery. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3016112560 | SECURISYN MEDICAL, LLC | Littleton, CO, US |
| 3004472848 | VELCRO (CHINA) FASTENING SYSTEMS COMPANY LIMITED | ZHANGJIAGANG Jiangsu, CN |
| 3007483335 | Qingdao Leckie Foam Products Co. Ltd. | Qingdao Shandong, CN |
| 3024808683 | WARRIORNP LLC | Bloomfield Hills, MI, US |
| 1824231 | ICU Medical, Inc. | Gary, IN, US |
3010305275 when referencing this establishment in official correspondence.