Data / Medical devices / United States / Atlas Healthcare LLC
Atlas Healthcare LLC: FDA-registered device maker in Miami, FL, United States, 3 510(k) clearances
Atlas Healthcare LLC is registered with the FDA (registration 3029802606) in Miami, FL, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029802606
- Address
- 411 Ne 52nd St, Miami, FL, United States, 33137
- Owner or operator
- Atlas Healthcare LLC (10089018)
- Roles
- Repackager or relabeler
- First device listed
- August 3, 2025
- Registered through
- 2026
- Brand names listed
- SomaGuard Autoclave Indicator Tape, SomaGuard Disposable Bouffant Caps, SomaGuard Disposable Isolation Gowns, SomaGuard Disposable Surgical Caps, SomaGuard Patient Bibs, SomaGuard Self-Adhesive Barrier Film, SomaGuard Self-Sealing Sterilization Pouches, SomaGuard Surgical Face Masks
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| December 17, 2024 | K241036 | Autoclave Indicator Tape; EO Indicator Tape | JOJ | Substantially Equivalent | Jiangmen New Era External Use Drug Co., Ltd. | accessdata.fda.gov |
| July 24, 2021 | K211363 | Medical Face Mask | FXX | Substantially Equivalent | Hubei Kangning Protective Products Co., Ltd. | accessdata.fda.gov |
| April 28, 2017 | K162258 | Self Sealing Sterilization Pouches | FRG | Substantially Equivalent | Tianchang Jiarui Packaging Material Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Cap, Surgical
- All makers of Unit, Operative Dental, Accessories
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Absorber, Saliva, Paper
- All makers of Non-Surgical Gown
Updated December 17, 2024. 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.