FDA Device Registration & Listing · SARASOTA, FL, US · Registration 1038758
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2007-03-20 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2007-03-20 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2006-07-14 |
| ILH | Splint, Hand, And Components | Physical Medicine | Class 1 | 890.3475 | 2017-11-07 |
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | Class 1 | 878.4018 | 2002-01-09 |
| LKB | Pad, Alcohol, Device Disinfectant | Unknown | Class U | N/A | 2018-07-13 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-10-24 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-05-03 |
| FRL | Fiber, Medical, Absorbent | General Hospital | Class 1 | 880.5300 | 2016-12-29 |
| LWF | Dilator, Nasal | Ear, Nose, Throat | Class 1 | 874.3900 | 2006-06-05 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | Class U | N/A | 2021-01-14 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-11-16 |
| IME | Pack, Hot Or Cold, Reusable | Physical Medicine | Class 1 | 890.5700 | 2025-12-08 |
| GEH | Unit, Cryosurgical, Accessories | General, Plastic Surgery | Class 2 | 878.4350 | 2013-08-20 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2012-12-26 |
| LRR | First Aid Kit With Drug | Unknown | Class N | N/A | 2013-01-30 |
| FPX | Strip, Adhesive, Closure, Skin | General Hospital | Class 1 | 880.5240 | 2007-11-26 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2006-06-05 |
| MGO | Closure, Wound, Adhesive | General, Plastic Surgery | Class 1 | 878.4018 | 2023-10-09 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2026-06-19 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2008-02-02 |
| HMP | Pad, Eye | General, Plastic Surgery | Class 1 | 878.4440 | 1988-02-08 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2022-06-22 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2017-06-28 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2004-01-12 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-03-07 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2012-12-26 |
| MDA | Elastomer, Silicone, For Scar Management | General, Plastic Surgery | Class 1 | 878.4025 | 2006-06-05 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9681195 | ASO PHILIPPINES, INC. | LAPU-LAPU CITY Cebu, PH |
| 3025145822 | ASO LLC | Palmetto, FL, US |
| 3005761322 | ASO AMERICAS, S. de R. L. de C. V. | JUAREZ Chihuahua, MX |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K843874 | Beiersdorf, Inc. | LEUKOPOR SURGICAL TAPE | 1985-02-21 |
| K915446 | Sun Glitz Corp. | STRETCH WRAP | 1992-05-06 |
| K833120 | Acme United Corp. | ONE TIME COMPOUND BENZOIN TINCTURE- | 1983-12-29 |
| K870091 | Avery Intl. | IV SECUREMENT DEVICE USING PCCE THERMO. FILM | 1987-02-04 |
| K052612 | Shanghai Antares Industries, Inc. | DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR | 2005-11-22 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0004-2014 | ASO, LLC | N/A | SHOPKO Waterproof Adhesive Pads Antibacterial.
Used for covering minor cuts, scrapes and burns. |
| Z-0003-06 | B. Braun Medical, Inc. | U | D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage. |
| Z-0038-2025 | 3M Company Health Care Business 3m Center | U | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R |
| 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 |
|---|---|---|
| 3013391391 | HERKIMER COUNTY CHAPTER NYSARC, INC. | Herkimer, NY, US |
| 3012677665 | TECHNO PLASTICS INDUSTRIES, INC. | Anasco, PR, US |
| 3038131023 | UNITED TECHNOLOGY VIETNAM COMPANY LIMITED | Quang Ha Commune Quang Ninh, VN |
| 3005360866 | QEL DOMINICANA S.A. | ESPERANZA Valverde, DO |
| 3043106338 | SHENZHEN SPONGE NEW MATERIAL CO. LTD | Shenzhen Guangdong, CN |
1038758 when referencing this establishment in official correspondence.