# Nicolet Biomedical, Inc.

- Location (FDA's records): Stoughton, WI
- FDA decisions: 18 (1995–2003): 18 510(k) clearances
- Names in FDA's records: Nicolet Biomedical, Inc. (10); Nicolet Biomedical (8)
- Product codes: GWQ (2), IYN (2), JAF (2), OLW (1), IKT (1), LLZ (1), GYC (1), GXY (1), ETN (1), GXZ (1), OMB (1), JOP (1)
- Predicates its devices cite: 22 (2 its own); citations of its devices by later devices: 21 (2 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Chalgren Enterprises, Inc.: 4 (https://510kreport.com/company/chalgren-enterprises)
- Ad-Tech Medical Instrument Corp: 3 (https://510kreport.com/company/ad-tech-medical-instrument)
- Nicolet Instrument Corp.: 2 (https://510kreport.com/company/nicolet-instrument)
- Aspect Medical Systems, Inc.: 1 (https://510kreport.com/company/aspect-medical-systems)
- Nicolet Biomedical Instruments: 1 (https://510kreport.com/company/nicolet-biomedical-instruments)
- Class A Ent.: 1 (https://510kreport.com/company/class-a-ent)
- Electro-Cap Intl., Inc.: 1 (https://510kreport.com/company/electro-cap-intl)
- Carolina Medical Electronics: 1 (https://510kreport.com/company/carolina-medical-electronics)

## Firms that cite its devices most
- Carefusion 209, Inc.: 2 (https://510kreport.com/company/carefusion-209)
- Axon Systems, Inc.: 2 (https://510kreport.com/company/axon-systems)
- Isurgical: 1 (https://510kreport.com/company/isurgical)
- Teleemg, LLC USA: 1 (https://510kreport.com/company/teleemg-usa)
- Viasonix, Ltd.: 1 (https://510kreport.com/company/viasonix)
- Everest Biomedical Instruments Co.: 1 (https://510kreport.com/company/everest-biomedical-instruments)
- Integra LifeSciences Corporation: 1 (https://510kreport.com/company/integra-lifesciences)
- Moberg Research, Inc.: 1 (https://510kreport.com/company/moberg-research)

## Its most-cited devices
- K991054: Bravo Multi-Modality System (1999), cited by 9
- K010019: Sterile Subdermal Needle Electrodes (2001), cited by 3
- K020218: Snap Eeg Monitor (2002), cited by 1
- K011818: Sterile Emg Electrodes (2001), cited by 1
- K013419: Nicolet Electromagnetic Navigation System (2001), cited by 1
- K021144: Subdural Strip Electrode (2002), cited by 1

## Recent decisions
- K020754: Nicolet Pioneer TC8080 (Apr 21, 2003)
- K021986: Brainet (Aug 23, 2002)
- K021144: Subdural Strip Electrode (Jun 24, 2002)
- K020218: Snap Eeg Monitor (Apr 22, 2002)
- K013281: Versalab Apm (Apr 18, 2002)
- K020955: Nicolet Electrocautery Detector (Apr 17, 2002)
- K013419: Nicolet Electromagnetic Navigation System (Dec 20, 2001)
- K011818: Sterile Emg Electrodes (Sep 6, 2001)

Source page: https://510kreport.com/company/nicolet-biomedical