Data / Medical devices / Panama / Medline Panama LLC S. de R.L.
Medline Panama LLC S. de R.L.: FDA-registered device maker in Veracruz, Arraijan Panama, Panama, 7 510(k) clearances
Medline Panama LLC S. de R.L. is registered with the FDA (registration 3016761372) in Veracruz, Arraijan Panama, Panama. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 6, 2022. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3016761372
- Address
- Panama-Pacifico, Boulevard Panama Pacifico, International Business Park, Building 3855, Office 209, Veracruz, Arraijan Panama, Panama, 1001
- Owner or operator
- Medline Industries, LP (1417592)
- Roles
- Exporter to the US
- First device listed
- August 8, 2006
- Registered through
- 2027
- Brand names listed
- 170019-Convenience Trays & Kits CSTM, AKTORmed, Aquablation Therapy, Aurora Surgical Pack, Convenience Trays & Kits CSTM, Convertors, Eclipse Surgical Drape, Eclipse Surgical Pack and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cover, Barrier, Protective | MMP | 2 | Exporter to the US | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Exporter to the US | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Exporter to the US | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Exporter to the US | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Exporter to the US | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Exporter to the US | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| October 6, 2022 | K220365 | Gemini Sterilization Wrap | FRG | Substantially Equivalent | Medline Industries, LP | accessdata.fda.gov |
| July 4, 2019 | K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) | FYA | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| September 8, 2017 | K170415 | Medline Hemo-Force DVT Compression Sleeve | JOW | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| August 25, 2011 | K110977 | VESOFLOW | JOW | Substantially Equivalent | Caremed Supply, Inc. | accessdata.fda.gov |
| September 22, 2003 | K032065 | MEDLINE BAND BAGS AND EQUIPMENT COVERS | MMP | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| February 25, 1997 | K964142 | MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS | KKX | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| September 16, 1996 | K962826 | MEDLINE RADIOLOGY-DIAGNOSTIC KITS | LRO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Surgical
- All makers of Drape, Surgical, Antimicrobial
- All makers of Drape, Surgical, Exempt
- All makers of General Surgery Tray
- All makers of Wrap, Sterilization
- All makers of Sleeve, Limb, Compressible
Updated October 6, 2022. 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.