FDA Device Registration & Listing · Beverly Hills, CA, US · Registration 3024088964
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| MHW | Dressing, Compression | General Hospital | Class 1 | 880.5075 | 2025-03-12 |
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | Class 1 | 878.5900 | 2025-03-12 |
| GWY | Pinwheel | Neurology | Class 1 | 882.1750 | 2025-03-12 |
| ILI | Sling, Arm | Physical Medicine | Class 1 | 890.3640 | 2025-03-12 |
| EGZ | Holder, Film, X-Ray | Dental | Class 1 | 872.1905 | 2025-03-12 |
| EFN | Cotton, Roll | Dental | Class 1 | 872.6050 | 2025-03-12 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2025-03-12 |
| HOX | Chart, Visual Acuity | Ophthalmic | Class 1 | 886.1150 | 2025-03-12 |
| JEW | Tip, Rubber, Oral Hygiene | Dental | Class 1 | 872.6650 | 2025-03-13 |
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | Class 1 | 876.5920 | 2025-03-13 |
| NRD | Unit, Operative Dental, Accessories | Dental | Class 1 | 872.6640 | 2025-03-12 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2025-03-12 |
| ILS | Adaptor, Hygiene | Physical Medicine | Class 1 | 890.5050 | 2025-03-12 |
| JDZ | Mixer, Cement, For Clinical Use | Orthopedic | Class 1 | 888.4210 | 2025-03-13 |
| NKJ | Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter | Dental | Class 1 | 872.3540 | 2025-03-13 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2026-05-29 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2026-05-29 |
| FOB | Bedpan | General Hospital | Class 1 | 880.6730 | 2025-03-12 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2026-06-04 |
| EIB | Syringe, Irrigating (Dental) | Dental | Class 1 | 872.4565 | 2025-03-12 |
| JEQ | Toothbrush, Powered | Dental | Class 1 | 872.6865 | 2024-04-26 |
| ECB | Unit, Syringe, Air And/Or Water | Dental | Class 1 | 872.4565 | 2025-03-12 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 2025-03-12 |
| KER | Container, Embedding | Pathology | Class 1 | 864.3010 | 2025-03-12 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2025-03-13 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-12 |
| ILH | Splint, Hand, And Components | Physical Medicine | Class 1 | 890.3475 | 2025-03-12 |
| FYF | Cap, Surgical | General, Plastic Surgery | Class 1 | 878.4040 | 2025-03-12 |
| FML | Chair, Blood Donor | General Hospital | Class 1 | 880.6140 | 2025-03-12 |
| DYN | Mouthpiece, Saliva Ejector | Dental | Class 1 | 872.6640 | 2024-04-26 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2026-05-29 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2026-05-29 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2026-05-29 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 2025-03-12 |
| NXB | Dispenser, Solid Medication | Physical Medicine | Class 1 | 890.5050 | 2025-03-12 |
| KME | Bedding, Disposable, Medical | General Hospital | Class 1 | 880.6060 | 2025-03-12 |
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | Class 2 | 878.4370 | 2025-03-12 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 2025-03-12 |
| JES | Floss, Dental | Dental | Class 1 | 872.6390 | 2025-03-12 |
| OHY | Pill Crusher/Cutter | General Hospital | Class 1 | 880.6430 | 2025-03-12 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2025-03-12 |
| FME | Gown, Examination | General Hospital | Class 1 | 880.6265 | 2025-03-12 |
| PEM | Dental Barriers And Sleeves | General, Plastic Surgery | Class 2 | 878.4370 | 2026-05-29 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2026-05-29 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2025-03-12 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2025-03-12 |
| EKM | Gutta-Percha | Dental | Class 1 | 872.3850 | 2024-04-26 |
| FZM | Stool, Operating-Room | General, Plastic Surgery | Class 1 | 878.4950 | 2025-03-12 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2025-03-12 |
| LZB | Finger Cot | General Hospital | Class 1 | 880.6250 | 2025-03-12 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2025-03-12 |
| GWZ | Percussor | Neurology | Class 1 | 882.1700 | 2025-03-12 |
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | Class 1 | 878.4022 | 2025-03-12 |
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | Class 1 | 880.6025 | 2025-03-12 |
| FPX | Strip, Adhesive, Closure, Skin | General Hospital | Class 1 | 880.5240 | 2025-03-12 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | Class 1 | 872.4565 | 2025-03-13 |
| PEM | Dental Barriers And Sleeves | General, Plastic Surgery | Class 2 | 878.4370 | 2026-05-29 |
| KPY | Shield, Protective, Personnel | Radiology | Class 1 | 892.6500 | 2025-03-13 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2025-03-12 |
| JOK | Scissors, Medical, Disposable | General Hospital | Class 1 | 880.6820 | 2025-03-12 |
| KMT | Tray, Fluoride, Disposable | Dental | Class 1 | 872.6870 | 2024-04-26 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2025-03-12 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2026-06-04 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-12 |
| NNI | Container, Specimen, Non-Sterile | Pathology | Class 1 | 864.3250 | 2025-03-12 |
| GDX | Scalpel, One-Piece | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-13 |
| NRU | Chair, Dental, Without Operative Unit | Dental | Class 1 | 872.6250 | 2025-03-12 |
| EKN | Point, Paper, Endodontic | Dental | Class 1 | 872.3830 | 2024-04-26 |
| KHR | Absorber, Saliva, Paper | Dental | Class 1 | 872.6050 | 2025-03-12 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2025-03-12 |
| EFT | Cleanser, Denture, Over The Counter | Dental | Class 1 | 872.3520 | 2025-03-12 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | Class 1 | 878.4450 | 2025-03-12 |
| LWK | Razor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-13 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 2025-03-13 |
| EFH | Paper, Articulation | Dental | Class 1 | 872.6140 | 2024-04-26 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2025-12-30 |
| CCX | Support, Patient Position | Anesthesiology | Class 1 | 868.6820 | 2025-12-30 |
| EHK | Cup, Prophylaxis | Dental | Class 1 | 872.6290 | 2025-03-12 |
| EHZ | Evacuator, Oral Cavity | Dental | Class 1 | 872.6640 | 2025-03-12 |
| FMW | Cover, Mattress (Medical Purposes) | General Hospital | Class 1 | 880.6190 | 2025-03-13 |
| FRL | Fiber, Medical, Absorbent | General Hospital | Class 1 | 880.5300 | 2025-03-12 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-12 |
| KYX | Dispenser, Liquid Medication | General Hospital | Class 1 | 880.6430 | 2025-03-13 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2026-06-04 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2025-03-12 |
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2025-03-12 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K830425 | Maddak, Inc. | TOILET SEAT RAISED | 1983-05-09 |
| K781592 | Henry Schein, Inc. | SURGICAL ASPIRATOR TIPS | 1978-12-04 |
| K201622 | Guangdong Kingfa Sci. & Tech.Co., Ltd. | Medical surgical mask | 2020-11-24 |
| K881618 | 3M Company | ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK | 1988-05-09 |
| K944481 | Garan Scientific, Inc. | THE HEART PROTECTOR | 1995-04-10 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2007 | N/A | 2 | 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant. |
| 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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004651767 | CLEARPOINT MEDICAL | Lachine Quebec, CA |
| 3011280379 | DONGGUAN CITY RISEN MEDICAL PRODUCTS CO., LTD | Dongguan Guangdong, CN |
| 3003767891 | PHARMAPLAST S.A.E. | ALEXANDRIA Al Iskandariyah, EG |
| 3030691709 | NextBeam | North Sioux City, SD, US |
| 1043542 | BRECON KNITTING MILL, INC. | Talladega, AL, US |
3024088964 when referencing this establishment in official correspondence.