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PARKER LABORATORIES, INC.

United States·US-MF-000013857

Last updated September 17, 2026

Information

Country
United States
Address
286, Eldridge Road, Fairfield , United States
LinkedIn
—
Facebook
—
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
DeviceModel / ReferenceRegistriesClassStatus
SignaGel Electrode Gel 15-60
EUDAMEDFDA UDI
Class IActive
Aquasonic 100 Ultrasound Transmission Gel 01-34
EUDAMEDFDA UDI
Class IActive
SignaCreme 17-05
EUDAMEDFDA UDI
Class IActive
Redux Electrolyte Paste 67-05
EUDAMEDFDA UDI
Class IActive
Aquasonic Clear Ultrasound Gel 03-54
EUDAMEDFDA UDI
Class IActive
Aquasonic Clear Ultrasound Gel 03-34
EUDAMEDFDA UDI
Class IActive
Aquaflex Ultrasound Gel Pad 04-15
EUDAMED
Class IActive
Aquaflex Ultrasound Gel Pad 04-02
EUDAMEDFDA UDI
Class IActive
Ultradrape UGPIV 34-15
EUDAMEDFDA UDI
Class IActive

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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.

DateRecall No.ClassStatusReason
Mar 22, 2024Z-1604-2024—open, classified

Product demonstrates low viscosity.

Jan 22, 2024Z-1204-2024—open, classified

Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.

Apr 13, 2017Z-1777-2018—terminated

There is a potential for the gel packets to have leaks in the packet seal.

Aug 6, 2014Z-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.