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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
Website: www.parkerlabs.com
LinkedIn: —
Facebook: —
Email: [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 2 of 3

Device	Model / Reference	Registries	Class	Status
Aqualube(tm)	K864556	FDA 510(k)	Class I	Active
Cotton Roll Compression Caps	K792391	FDA 510(k)	Class I	Active
Polygel Ultrasound Gel	K851895	FDA 510(k)	Class II	Active
Dyna System	K855167	FDA 510(k)	Class I	Active
Spectra R Pad	K791013	FDA 510(k)	Class II	Active
Accutron Pollution Reducer	K790638	FDA 510(k)	Class I	Active
Resil	K840548	FDA 510(k)	Class II	Active
Cyanobond	K770067	FDA 510(k)	Class II	Active
Anti-Mist, Anti-Fog Eyeglass & Dental	K822711	FDA 510(k)	Class I	Active
Acrylic Solder	K861239	FDA 510(k)	Class II	Active
Desensitron	K771130	FDA 510(k)	Class II	Active
Signapad	K780973	FDA 510(k)	Class II	Active
Articulating Paper	K771011	FDA 510(k)	Class I	Active
Provit	K800060	FDA 510(k)	Class II	Active
Scan Ultrasound Gel	11-28	EUDAMEDFDA UDI	Class I	Active
Aquasonic Clear Ultrasound Gel	03-50	EUDAMEDFDA UDI	Class I	Active
Aquasonic 100 Ultrasound Transmission Gel	01-50	EUDAMEDFDA UDI	Class I	Active
Alpha-Stim	SL250	EUDAMEDFDA UDI	Class I	Active
Spectra 360 Electrode Gel	12-02	EUDAMEDFDA UDI	Class I	Active
SignaCreme	17-20	EUDAMEDFDA UDI	Class I	Active
Aquagel	57-20	EUDAMEDFDA UDI	Class I	Active
Aquagel Lubricating Gel	57-05	EUDAMEDFDA UDI	Class I	Active
Eclipse Probe Cover	38-01-1	EUDAMEDFDA UDI	Class I	Active
Spectra 360 Electrode Gel	12-08	EUDAMEDFDA UDI	Class I	Active
SignaSpray Electrode Solution and Skin Prep	18-04	EUDAMEDFDA UDI	Class I	Active
Aquasonic Clear Ultrasound Gel	03-02	EUDAMEDFDA UDI	Class I	Active
Eclipse Probe Cover	38-01	EUDAMEDFDA UDI	Class I	Active
Tensive Conductive Adhesive Gel	22-60	EUDAMEDFDA UDI	Class I	Active
Eclipse 3D Probe Cover	38-03	EUDAMEDFDA UDI	Class I	Active
Scan Ultrasound Gel	11-08	EUDAMEDFDA UDI	Class I	Active
Logiscan Blue	MLLSB50	EUDAMED	Class I	Active
SignaSpray Electrode Solution and Skin Prep	18-25	EUDAMEDFDA UDI	Class I	Active
Aquasonic 100 Ultrasound Transmission Gel	01-08	EUDAMEDFDA UDI	Class I	Active
Aquaflex Ultrasound Gel Pad	04-40	EUDAMED	Class I	Active
Polysonic Ultrasound Lotion	21-50	EUDAMEDFDA UDI	Class I	Active
Delphinus Sequr Breast Interface	900-00010	EUDAMED	Class I	Active
Timm Medical Lubricating Gel	1401	EUDAMED	Class I	Active
Alpha-Stim	SL50	EUDAMEDFDA UDI	Class I	Active
SignaGel Electrode Gel	15-25	EUDAMEDFDA UDI	Class I	Active
Pulsetto Conductive Gel	15-99-470595	EUDAMED	Class I	Active
Polysonic Ultrasound Lotion	20-28	EUDAMEDFDA UDI	Class I	Active
SignaSpray Electrode Solution and Skin Prep	18-28	EUDAMEDFDA UDI	Class I	Active
Polysonic Ultrasound Lotion	20-50	EUDAMEDFDA UDI	Class I	Active
Redux Electrolyte Gel	65-04	EUDAMEDFDA UDI	Class I	Active
Redux Electrolyte Creme	66-04	EUDAMEDFDA UDI	Class I	Active
Logiscan Clear	MLLSC25	EUDAMED	Class I	Active
Aquasonic 100 Ultrasound Transmission Gel	01-02	EUDAMEDFDA UDI	Class I	Active
Polysonic Ultrasound Lotion	20-08	EUDAMEDFDA UDI	Class I	Active
Scan Ultrasound Gel	11-28S	EUDAMEDFDA UDI	Class I	Active
Ultradrape II UGPIV	34-10	EUDAMEDFDA UDI	Class I	Active

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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.

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.