FDA Device Registration & Listing · Laguna Beach, CA, US · Registration 3044466317
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KDT | Container, Specimen Mailer And Storage, Sterile | Pathology | Class 1 | 864.3250 | 2022-09-19 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2026-05-09 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2026-05-09 |
| HMP | Pad, Eye | General, Plastic Surgery | Class 1 | 878.4440 | 2026-05-09 |
| KME | Bedding, Disposable, Medical | General Hospital | Class 1 | 880.6060 | 2026-05-09 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2022-12-21 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 2022-09-12 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2026-05-09 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2026-05-09 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2026-05-09 |
| OVR | Kit, First Aid, Talking | General, Plastic Surgery | Class 1 | 878.4014 | 2022-09-16 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2026-05-09 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2026-05-09 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 2026-05-09 |
| JRC | Micro Pipette | Clinical Chemistry | Class 1 | 862.2050 | 2022-11-04 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2026-05-09 |
| OMW | Adhesive Backed Thermal Skin Patches | Physical Medicine | Class 1 | 890.5710 | 2026-05-09 |
| NNT | Punch, Gelfoam, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2026-05-09 |
| FXO | Suit, Surgical | General, Plastic Surgery | Class 1 | 878.4040 | 2026-05-09 |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Pathology | Class 1 | 864.3250 | 2026-05-09 |
| GJW | Pipette, Pasteur | Hematology | Class 1 | 864.6160 | 2022-12-21 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2022-09-09 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2022-11-02 |
| KEW | Slides, Microscope | Pathology | Class 1 | 864.3010 | 2026-05-09 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | Class 1 | 862.2050 | 2022-12-21 |
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | Class 1 | 880.6025 | 2026-05-09 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K880871 | John Wagner Associates, Inc. | GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER | 1988-05-20 |
| 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 |
| K153050 | Co-Innovation Biotech Co., Ltd. | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | 2016-04-26 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0505-2022 | Philips North America Llc | 1 | Infa-Therm Transport Mattress, Reference Number 989805616831 1015 |
| Z-0506-2022 | Philips North America Llc | 1 | Infant Heel Warmers w/strap, Reference # 989805603201 1223 |
| 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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3027605742 | Xiamen Zhiyuan Medical Technology Co., Ltd. | XIAMEN Fujian, CN |
| 2320762 | DEROYAL INDUSTRIES, INC. | NEW TAZEWELL, TN, US |
| 3010420046 | CITOTEST Labware Manufacturing CO., LTD. | Haimen Jiangsu, CN |
| 1055236 | DEROYAL INDUSTRIES, INC. | NEW TAZEWELL, TN, US |
| 3009526936 | CGN Huaray Technology Co., Ltd. Suzhou Branch | Suzhou Jiangsu, CN |
3044466317 when referencing this establishment in official correspondence.