Data / Medical devices / United States / Nikomed U.s.a., Inc.
Nikomed U.s.a., Inc.: FDA-registered device maker in Hatboro, PA, United States, 9 510(k) clearances
Nikomed U.s.a., Inc. is registered with the FDA (registration 2245574) in Hatboro, PA, United States. It lists 15 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 11, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2245574
- Address
- 2800 Turnpike Dr, Hatboro, PA, United States, 19040
- Owner or operator
- NIKOMED U.S.A., INC. (9023845)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- January 5, 2010
- Registered through
- 2026
- Brand names listed
- 3M, CPR Mask, Coreshieldz, Disposable Non-Surgical Gown, Gallant Disposable Prep Razor, ME Medical Surgical Clipper, MESI ABPI MD, MESI BP Cuffs 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 |
|---|---|---|---|---|---|---|
| December 11, 2020 | K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | JOM | Substantially Equivalent | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | accessdata.fda.gov |
| January 11, 2018 | K172655 | Automated ankle brachial pressure index measuring device | JOM | Substantially Equivalent | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | accessdata.fda.gov |
| July 22, 2015 | K143152 | TM-ABI system | JOM | Substantially Equivalent | Ld Technology, LLC | accessdata.fda.gov |
| September 13, 2010 | K102173 | MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712 | MSH | Substantially Equivalent | Moldex/Metric, Inc. | accessdata.fda.gov |
| November 21, 2006 | K063161 | SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL | GEI | Substantially Equivalent | Leonhard Lang GmbH | accessdata.fda.gov |
| January 9, 2003 | K022909 | NIKOMED TRACE 1 ECG ELECTRODES | DRX | Substantially Equivalent | Nikomed U.S.A., Inc. | accessdata.fda.gov |
| February 4, 2000 | K000079 | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M | HAM | Substantially Equivalent | Nikomed U.S.A., Inc. | accessdata.fda.gov |
| November 3, 1999 | K993306 | NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) | HAM | Substantially Equivalent | Paladin Medical, Inc. | accessdata.fda.gov |
| May 1, 1996 | K955382 | 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 | FXX | Substantially Equivalent | 3M Company | accessdata.fda.gov |
Compare with other makers
- All makers of Respirator, Surgical
- All makers of Stethoscope, Manual
- All makers of Electrode, Electrocardiograph
- All makers of Razor, Surgical
- All makers of Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- All makers of Apparatus, Electrosurgical
Updated December 11, 2020. 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.