FDA Device Registration & Listing · Pu Dong New Area Shanghai, CN · Registration 3010198795
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2022-05-23 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2022-05-23 |
| EYY | Drape, Urological, Disposable | General, Plastic Surgery | Class 2 | 878.4370 | 2022-05-23 |
| FON | Bag, Drainage, With Adhesive, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2023-11-15 |
| KHR | Absorber, Saliva, Paper | Dental | Class 1 | 872.6050 | 2022-05-23 |
| FRL | Fiber, Medical, Absorbent | General Hospital | Class 1 | 880.5300 | 2022-05-23 |
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-23 |
| JTM | Anaerobic Box Glove | Microbiology | Class 1 | 866.2120 | 2022-05-23 |
| IQI | Orthosis, Limb Brace | Physical Medicine | Class 1 | 890.3475 | 2022-05-23 |
| FME | Gown, Examination | General Hospital | Class 1 | 880.6265 | 2022-05-23 |
| EFN | Cotton, Roll | Dental | Class 1 | 872.6050 | 2022-05-23 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-23 |
| CAT | Cannula, Nasal, Oxygen | Anesthesiology | Class 1 | 868.5340 | 2022-05-23 |
| KPY | Shield, Protective, Personnel | Radiology | Class 1 | 892.6500 | 2022-05-23 |
| HST | Apparatus, Traction, Non-Powered | Orthopedic | Class 1 | 888.5850 | 2022-05-23 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2022-05-23 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | Class 1 | 878.4022 | 2023-11-15 |
| ILI | Sling, Arm | Physical Medicine | Class 1 | 890.3640 | 2022-05-23 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-23 |
| MDA | Elastomer, Silicone, For Scar Management | General, Plastic Surgery | Class 1 | 878.4025 | 2023-11-15 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | Class 1 | 878.4450 | 2022-05-23 |
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | Class 1 | 868.6810 | 2022-05-23 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | Gastroenterology, Urology | Class 1 | 876.5250 | 2022-05-23 |
| LRJ | Disinfectant, Medical Devices | General Hospital | Class 1 | 880.6890 | 2022-05-23 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2022-05-23 |
| KME | Bedding, Disposable, Medical | General Hospital | Class 1 | 880.6060 | 2022-05-23 |
| FRK | Chair, Examination And Treatment | General Hospital | Class 1 | 880.6140 | 2022-05-23 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2022-05-23 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 2022-05-23 |
| FLK | Thermometer, Clinical Mercury | General Hospital | Class 2 | 880.2920 | 2022-05-23 |
| MSH | Respirator, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2022-05-23 |
| FYF | Cap, Surgical | General, Plastic Surgery | Class 1 | 878.4040 | 2022-05-23 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2022-05-23 |
| IME | Pack, Hot Or Cold, Reusable | Physical Medicine | Class 1 | 890.5700 | 2022-05-23 |
| BYG | Mask, Oxygen | Anesthesiology | Class 1 | 868.5580 | 2022-05-23 |
| FMP | Protector, Skin Pressure | General Hospital | Class 1 | 880.6450 | 2022-05-23 |
| KYX | Dispenser, Liquid Medication | General Hospital | Class 1 | 880.6430 | 2022-05-23 |
| IWO | Apron, Protective | Radiology | Class 1 | 892.6500 | 2022-05-23 |
| LGF | Component, Cast | Orthopedic | Class 1 | 888.5940 | 2022-05-23 |
| FXP | Cover, Shoe, Operating-Room | General, Plastic Surgery | Class 1 | 878.4040 | 2022-05-23 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2022-05-23 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2022-05-23 |
| MHW | Dressing, Compression | General Hospital | Class 1 | 880.5075 | 2022-05-23 |
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | Class 1 | 878.4018 | 2022-05-23 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Anesthesiology | Class 1 | 868.5640 | 2022-05-23 |
| PKS | Exerciser, Non-Measuring For Stroke Rehabilitation | Physical Medicine | Class 1 | 890.5370 | 2022-05-23 |
| NEC | Bandage, Liquid, Skin Protectant | General Hospital | Class 1 | 880.5090 | 2022-05-23 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2022-05-23 |
| EZQ | Pouch, Colostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2022-05-23 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 2022-05-23 |
| FFH | Collector, Urine, Pediatric, For Indwelling Catheter | Gastroenterology, Urology | Class 2 | 876.5250 | 2022-05-23 |
| ECB | Unit, Syringe, Air And/Or Water | Dental | Class 1 | 872.4565 | 2022-05-23 |
| MKY | System, Skin Closure | General, Plastic Surgery | Class 1 | 878.4320 | 2023-11-15 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K881936 | Iberhospitex, S.A. | OPER-FILM-ADHESIVE MEMBRANE | 1988-08-31 |
| K831798 | I M, Inc. | DISPOSABLE SCALPELS | 1983-07-19 |
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| K873512 | Arthropedics, Inc. | SERRATED GRASPING FORCEPS, RIGHT | 1987-11-02 |
| K790050 | Stanford Professional Products | SPONGES, STANFORD STERILE LAP | 1979-01-17 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0013-2019 | COVIDIEN LLC | 1 | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332
Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing. |
| Z-0014-2019 | COVIDIEN LLC | 1 | Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. |
| Z-0015-2019 | COVIDIEN LLC | 1 | Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. |
| Z-0016-2019 | COVIDIEN LLC | 1 | Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. |
| Z-0017-2019 | COVIDIEN LLC | 1 | Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3016445778 | LABNPEOPLE | Yangju-si Gyeonggi, KR |
| 3033273018 | RASHENDZ, INC. | St Petersburg, FL, US |
| 3008656870 | DALIAN ORIENTECH CO.,LTD | Dalian Liaoning, CN |
| 1629057 | WINFIELD LABORATORIES, INC. | Richardson, TX, US |
| 3021695082 | BEONE CO., LTD. | Gimpo Gyeonggi, KR |
3010198795 when referencing this establishment in official correspondence.