Is this your brand? Sign in to claim ownership.
Sign in to claim this brandPARKER LABORATORIES, INC.
United States·US-MF-000013857
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 286, Eldridge Road, Fairfield , United States
- Website
- www.parkerlabs.com
- —
- —
- [email protected]
- Phone
- +1 973 276 9500
- PRRC Contact
- Neal Buchalter
- EUDAMED SRN
- US-MF-000013857
- FDA FEI Number
- 2212018
- DUNS Number
- —
Catalogue (109)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SignaGel Electrode Gel | 15-60 | EUDAMEDFDA UDI | Class I | Active |
| Aquasonic 100 Ultrasound Transmission Gel | 01-34 | EUDAMEDFDA UDI | Class I | Active |
| SignaCreme | 17-05 | EUDAMEDFDA UDI | Class I | Active |
| Redux Electrolyte Paste | 67-05 | EUDAMEDFDA UDI | Class I | Active |
| Aquasonic Clear Ultrasound Gel | 03-54 | EUDAMEDFDA UDI | Class I | Active |
| Aquasonic Clear Ultrasound Gel | 03-34 | EUDAMEDFDA UDI | Class I | Active |
| Aquaflex Ultrasound Gel Pad | 04-15 | EUDAMED | Class I | Active |
| Aquaflex Ultrasound Gel Pad | 04-02 | EUDAMEDFDA UDI | Class I | Active |
| Ultradrape UGPIV | 34-15 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 22, 2024 | Z-1604-2024 | — | open, classified | Product demonstrates low viscosity. |
| Jan 22, 2024 | Z-1204-2024 | — | open, classified | Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60. |
| Apr 13, 2017 | Z-1777-2018 | — | terminated | There is a potential for the gel packets to have leaks in the packet seal. |
| Aug 6, 2014 | Z-0145-2015 | — | terminated | Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers. |