Data / Medical devices / United States / Aso LLC
Aso LLC: FDA-registered device maker in Sarasota, FL, United States, 13 510(k) clearances
Aso LLC is registered with the FDA (registration 1038758) in Sarasota, FL, United States. It lists 27 device types. The FDA files 13 510(k) clearances under its listings, the newest dated January 30, 2023. 7 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1038758
- Address
- 300 Sarasota Center BLVD., Sarasota, FL, United States, 34240
- Owner or operator
- ASO LLC (1038758)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 8, 1988
- Registered through
- 2027
- Brand names listed
- DRESSING, WOUND, HYDROPHILIC, Tender Tape
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Closure, Wound, Adhesive | MGO | 1 | Complaint file establishment | accessdata.fda.gov |
| Dilator, Nasal | LWF | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Complaint file establishment | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Complaint file establishment | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Complaint file establishment | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Complaint file establishment | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Complaint file establishment | accessdata.fda.gov |
| Nursing Pad, Cohesive Gel | NXH | 1 | Complaint file establishment | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Complaint file establishment | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Complaint file establishment | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Complaint file establishment | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Complaint file establishment | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Complaint file establishment | accessdata.fda.gov |
| Strip, Adhesive, Closure, Skin | FPX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Unit, Cryosurgical, Accessories | GEH | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 30, 2023 | K221532 | PHMB Wound Dressing | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| January 13, 2023 | K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing | FRO | Substantially Equivalent | Winner Medical Co., Ltd. | accessdata.fda.gov |
| October 25, 2019 | K192667 | gel-e Flex+ gel OTC | QSY | Substantially Equivalent | Gel-E, Inc. | accessdata.fda.gov |
| September 11, 2017 | K171317 | Clear Vinyl Powder-free Patient Examination Gloves | LYZ | Substantially Equivalent | Shandong Zhi Hong Medical Products, Co. , Ltd. | accessdata.fda.gov |
| June 5, 2013 | K130599 | WART FREEZE | GEH | Substantially Equivalent | Koninklijke Utermohlen NV | accessdata.fda.gov |
| October 16, 2012 | K121992 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR | LZA | Substantially Equivalent | Xinwei (Shandong) Plastic and Rubber Products Co., | accessdata.fda.gov |
| August 3, 2012 | K121526 | POWER-FREE NITRILE PATIENT EXAMINATION GLOVES | LZA | Substantially Equivalent | Shandong Junchi Medical Products Co., Ltd. | accessdata.fda.gov |
| January 5, 2011 | K100613 | BIOMED WOUND CLEANSER | FRO | Substantially Equivalent | Biomed Laboratories, Inc. | accessdata.fda.gov |
| November 22, 2010 | K102444 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Yingbo Medical Products, Inc. | accessdata.fda.gov |
| September 14, 2007 | K070685 | KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 | FRO | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| September 12, 2007 | K070653 | KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 | FRO | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| February 17, 1999 | K983368 | CARE BAND ANTIBACTERIAL BANDAGES | KGX | Substantially Equivalent | Aso Corp. | accessdata.fda.gov |
| January 29, 1988 | K874813 | OMED WOUND CLOSURE STRIPS | FPX | Substantially Equivalent | Oxboro Medical Intl., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 23, 2023 | 91970 | Class II | Ongoing | WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES, 110 ASSORTED SIZES (retail package) | The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling. | accessdata.fda.gov |
| June 22, 2022 | 90538 | Class II | Ongoing | (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 99884 | The product falls apart during handling after removal from its primary packaging. | accessdata.fda.gov |
| March 2, 2022 | 89824 | Class II | Terminated | First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon) | Kits contained recalled acetaminophen. | accessdata.fda.gov |
| October 16, 2018 | 81555 | Class II | Ongoing | Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box | Potential that gauze pads may not be fully sterilized | accessdata.fda.gov |
| June 10, 2015 | 71682 | Class II | Terminated | Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes | Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label. | accessdata.fda.gov |
| August 21, 2013 | 66357 | Class II | Terminated | SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns. | No antibacterial bandages were packed in boxes labeled as antibacterial. | accessdata.fda.gov |
| July 26, 2013 | 65819 | Class II | Terminated | CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds. | This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. | accessdata.fda.gov |
Compare with other makers
- All makers of Splint, Hand, And Components
- All makers of Pad, Eye
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- All makers of Dressing, Wound, Drug
- All makers of Pad, Alcohol, Device Disinfectant
Updated May 2, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.