# Nikomed U.S.A., Inc.

- Location (FDA's records): Doylestown, PA
- FDA decisions: 15 (1987–2003): 15 510(k) clearances
- Product codes: DRX (12), HAM (1), LDD (1), CBH (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 13 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Maersk Medical A/S: 10 (https://510kreport.com/company/maersk-medical-a-s)
- Thermage, Inc.: 2 (https://510kreport.com/company/thermage)
- Radionics, Inc.: 1 (https://510kreport.com/company/radionics)

## Its most-cited devices
- K000079: Nikopad Electrosurgical Grounding Pad, Model 4777M (2000), cited by 3
- K950476: Disposable Ecg Monitoring Electrode #4440 60MM, #4420 40MM (1995), cited by 1
- K950478: Disposable Ecg Monitoring Electrode #4570 38X60MM (1995), cited by 1
- K950474: Disposable Ecg Monitoring Electrode #4533 32X45MM (1995), cited by 1
- K950473: Disposable Ecg Monitoring Electrode (1995), cited by 1
- K950479: Disposable Ecg Monitoring Electrode #4600 60MM, #4610 45MM (1995), cited by 1

## Recent decisions
- K022909: Nikomed Trace 1 Ecg Electrodes (Jan 9, 2003)
- K000079: Nikopad Electrosurgical Grounding Pad, Model 4777M (Feb 4, 2000)
- K950473: Disposable Ecg Monitoring Electrode (Dec 12, 1995)
- K950475: Disposable Ecg Monitoring Electrode #4530, #4540 (Nov 14, 1995)
- K950472: Disposable Ecg Monitoring Electrode #4110 45MM, #4140 35MM (Nov 14, 1995)
- K950478: Disposable Ecg Monitoring Electrode #4570 38X60MM (Nov 6, 1995)
- K950474: Disposable Ecg Monitoring Electrode #4533 32X45MM (Nov 6, 1995)
- K950471: Disposable Ecg Monitoring Electrode #4580 32X45MM (Nov 6, 1995)

Source page: https://510kreport.com/company/nikomed-usa