FDA Device Registration & Listing · WUXI Jiangsu, CN · Registration 3018503755
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | Class 1 | 868.6810 | 2025-02-20 |
| ILI | Sling, Arm | Physical Medicine | Class 1 | 890.3640 | 2025-12-03 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2024-04-11 |
| ITQ | Joint, Knee, External Brace | Physical Medicine | Class 1 | 890.3475 | 2025-12-03 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2024-04-10 |
| KTC | Bath, Sitz, Nonpowered | Physical Medicine | Class 1 | 890.5125 | 2023-06-20 |
| FTA | Light, Surgical, Accessories | General, Plastic Surgery | Class 2 | 878.4580 | 2021-03-04 |
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | Class 2 | 880.6740 | 2025-04-29 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2025-04-29 |
| NXB | Dispenser, Solid Medication | Physical Medicine | Class 1 | 890.5050 | 2023-06-20 |
| KDQ | Bottle, Collection, Vacuum | General Hospital | Class 2 | 880.6740 | 2025-08-28 |
| KZD | Infusor, Pressure, For I.V. Bags | General Hospital | Class 1 | 880.5420 | 2025-02-26 |
| IOY | Support, Arm | Physical Medicine | Class 1 | 890.3475 | 2025-12-03 |
| GEC | Brush, Scrub, Operating-Room | General, Plastic Surgery | Class 1 | 878.4800 | 2024-04-11 |
| CAE | Airway, Oropharyngeal, Anesthesiology | Anesthesiology | Class 1 | 868.5110 | 2024-04-19 |
| IPY | Orthosis, Lumbo-Sacral | Physical Medicine | Class 1 | 890.3490 | 2024-04-07 |
| LHI | Set, I.V. Fluid Transfer | General Hospital | Class 2 | 880.5440 | 2024-04-19 |
| CAT | Cannula, Nasal, Oxygen | Anesthesiology | Class 1 | 868.5340 | 2025-12-21 |
| FNP | Urinal | General Hospital | Class 1 | 880.6730 | 2023-06-20 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2024-04-19 |
| ITW | Joint, Ankle, External Brace | Physical Medicine | Class 1 | 890.3475 | 2024-04-07 |
| KIC | Cushion, Flotation | Physical Medicine | Class 1 | 890.3175 | 2023-06-20 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2025-04-29 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | Class 2 | 876.5250 | 2024-09-20 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Anesthesiology | Class 1 | 868.5640 | 2026-05-25 |
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | Class 1 | 878.4160 | 2025-12-30 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | Class 2 | 880.6740 | 2023-07-27 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2024-04-11 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K832124 | Med-West, Inc. | CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI | 1983-08-12 |
| K162500 | Spyder Medical | Ostial Sprit Cannulae | 2017-01-12 |
| K944481 | Garan Scientific, Inc. | THE HEART PROTECTOR | 1995-04-10 |
| K243985 | Icu Medical, Inc. | Rio Drug Reconstitution Transfer Device | 2025-01-22 |
| K222718 | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Vial Adapter | 2023-03-10 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0007-2013 | Invuity, Inc. | 2 | BriteField illuminated Suction Device;
Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray.
The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source. |
| Z-0003-2022 | Medtronic Perfusion Systems | 2 | Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile. |
| Z-0021-2018 | OriGen Biomedical, Inc. | 2 | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. |
| Z-0002-2014 | King Systems Corp. | 1 | King LTS-D Oropharyngeal Airways
Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents. |
| Z-0007-2017 | Baxter Corporation Englewood | 2 | 0.2 Micron Filter, 50 mm
Product Usage:
The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3016676856 | QUICK AID LLC | Clearwater, FL, US |
| 1062154 | NDH MEDICAL, INC. | Saint Petersburg, FL, US |
| 3025831202 | TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD. | Dongguan City Guangdong, CN |
| 3011237770 | Vygon Verneuil | Verneuil En Halatte Oise, FR |
| 3016734145 | CREATE BIOTECH CO., LTD. | Taoyuan City, TW |
3018503755 when referencing this establishment in official correspondence.