Data / Medical devices / United States / Szy Holdings LLC.
Szy Holdings LLC.: FDA-registered device maker in Brooklyn, NY, United States, 9 510(k) clearances
Szy Holdings LLC. is registered with the FDA (registration 2427500) in Brooklyn, NY, United States. It lists 18 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 1, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2427500
- Address
- 300 LIberty Ave., Brooklyn, NY, United States, 11207
- Owner or operator
- Ever Ready First Aid (2427500)
- Roles
- Repackager or relabeler
- First device listed
- March 5, 2019
- Registered through
- 2026
- Brand names listed
- 3M, 3M COMPANY, 3M HEALTHCARE, 3M RANGER, BD, BD NOKOR, Ever Dixie, Ever Ready First Aid and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| March 1, 2019 | K181730 | BD Vacutainer Eclipse UltraFill Blood Collection Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 8, 2007 | DEN060009 | 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR | NZJ | Unknown | 3M Company | accessdata.fda.gov |
| June 26, 2006 | K060939 | RANGER IRRIGATION FLUID WARMING SYSTEM | LGZ | Substantially Equivalent | Arizant Healthcare, Inc. | accessdata.fda.gov |
| April 16, 2002 | K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 | FPA | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| April 9, 1997 | K970796 | 3M RED DOT 2560 & 2570 MONITORING ELECTRODES | DRX | Substantially Equivalent | 3M Healthcare | accessdata.fda.gov |
| November 14, 1995 | K955043 | WELCH ALLYN BI-OTOSCOPE | ERA | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| July 10, 1995 | K952578 | WELCH ALLY OTOSCOPE | ERA | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| July 23, 1990 | K901845 | TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX | KGX | Substantially Equivalent for Some Indications | 3M Company | accessdata.fda.gov |
| July 28, 1987 | K872757 | OPSITE SPECIALITY DRAPES | KKX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Warmer, Thermal, Infusion Fluid
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Electrode, Electrocardiograph
- All makers of Stethoscope, Manual
- All makers of Set, Administration, Intravascular
- All makers of Tape And Bandage, Adhesive
Updated March 1, 2019. 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.