FDA Device Registration & Listing · Dongyang Zhejiang, CN · Registration 3021282544
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LKB | Pad, Alcohol, Device Disinfectant | Unknown | Class U | N/A | 2021-11-19 |
| IAL | Iodine (Tincture) | Pathology | Class 1 | 864.4010 | 2021-11-19 |
| EFN | Cotton, Roll | Dental | Class 1 | 872.6050 | 2021-11-17 |
| ILI | Sling, Arm | Physical Medicine | Class 1 | 890.3640 | 2021-11-19 |
| MSH | Respirator, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2021-11-24 |
| CAE | Airway, Oropharyngeal, Anesthesiology | Anesthesiology | Class 1 | 868.5110 | 2021-11-17 |
| BYG | Mask, Oxygen | Anesthesiology | Class 1 | 868.5580 | 2021-11-19 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2021-11-17 |
| LZB | Finger Cot | General Hospital | Class 1 | 880.6250 | 2025-06-18 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2021-11-19 |
| HMP | Pad, Eye | General, Plastic Surgery | Class 1 | 878.4440 | 2021-11-17 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2021-11-19 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2021-11-17 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | Class 1 | 878.4022 | 2021-11-17 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2021-11-17 |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | General, Plastic Surgery | Class 1 | 878.4018 | 2021-11-19 |
| LRR | First Aid Kit With Drug | Unknown | Class N | N/A | 2021-11-19 |
| IWP | Radiographic Protective Glove | Radiology | Class 1 | 892.6500 | 2021-11-24 |
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | Class 1 | 878.5900 | 2021-11-19 |
| JOK | Scissors, Medical, Disposable | General Hospital | Class 1 | 880.6820 | 2021-11-19 |
| NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile | General, Plastic Surgery | Class 1 | 878.3910 | 2021-11-19 |
| BTQ | Airway, Nasopharyngeal | Anesthesiology | Class 1 | 868.5100 | 2021-11-17 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K102092 | Prestige Ameritech | PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES | 2010-10-06 |
| 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 |
| K881936 | Iberhospitex, S.A. | OPER-FILM-ADHESIVE MEMBRANE | 1988-08-31 |
| K843874 | Beiersdorf, Inc. | LEUKOPOR SURGICAL TAPE | 1985-02-21 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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-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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3005750815 | HOME AIDE DIAGNOSTICS, INC. | Deerfield Bch, FL, US |
| 3013823570 | GUANGZHOU BAOLI HARDWARE & ELECTRONIC CO.,LTD. | Guangzhou Guangdong, CN |
| 3015173212 | Medline Industries, LP - Mexicali (MXC) | Mexicali Baja California, MX |
| 3004704697 | CAREMAX CO., LTD. | SUZHOU, JIANGSU PROVINCE, CN |
| 3035382642 | BONG BACH TUYET JOINT STOCK COMPANY | Ho Chi Minh, VN |
3021282544 when referencing this establishment in official correspondence.