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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 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Alpha-Stim | 18-25-155614-1 | FDA UDI | Class II | Active |
| innovo Spray | 18-52-970605 | FDA UDI | Class II | Active |
| Aquagel | LUBRICATING GEL | FDA UDI | Class I | Active |
| Sterile Aquasonic | ULTRASOUND TRANSMISSION GEL | FDA UDI | Class II | Active |
| Parker Labs | Latex probe cover | FDA UDI | Class II | Active |
| 1% KCl GEL | 99-01-730090 | FDA UDI | Class II | Active |
| Rebuilder | Rebuilder Electrolyte 250 ml Spray | FDA UDI | Class II | Active |
| Aquaflex | ULTRASOUND GEL PAD | FDA UDI | Class II | Active |
| BrainScope | 99-1000-004 | FDA UDI | Class II | Active |
| Taylor Industries | Electrode Gel | FDA UDI | Class II | Active |
| Aquagel | LUBRICATING GEL | FDA UDI | Class I | Active |
| Timm Medical | 57-05-144738 | FDA UDI | Class I | Active |
| Soterixmedical HD-Gel | 15-0135 | FDA UDI | Class II | Active |
| Aquasonic 100 | ULTRASOUND TRANSMISSION GEL | FDA UDI | Class II | Active |
| BioWrap | 17-04-155714 | FDA UDI | Class II | Active |
| Signaspray | ELECTRODE SOLUTION AND SKIN PREP | FDA UDI | Class II | Active |
| Aquagel | LUBRICATING GEL | FDA UDI | Class I | Active |
| Aquaflex | ULTRASOUND GEL PAD | FDA UDI | Class II | Active |
| Aquasonic Clear | ULTRASOUND GEL | FDA UDI | Class II | Active |
| Aquasonic 100 | ULTRASOUND TRANSMISSION GEL | FDA UDI | Class II | Active |
| Parker Labs | Transeptic Cleansing Solution | FDA UDI | Class II | Unknown |
| Alpha-Stim | 18-50-155614-1 | FDA UDI | Class II | Active |
| Sterile Aquasonic | ULTRASOUND TRANSMISSION GEL | FDA UDI | Class II | Active |
| Polysonic | ULTRASOUND LOTION | FDA UDI | Class II | Active |
| Aquasonic 100 | ULTRASOUND TRANSMISSION GEL | FDA UDI | Class II | Active |
| Aquaflex | ULTRASOUND GEL PAD | FDA UDI | Class II | Active |
| Aquaflex | ULTRASOUND GEL PAD | FDA UDI | Class II | Active |
| Rebuilder | Rebuilder Electrolyte 1 gallon | FDA UDI | Class II | Active |
| MedVat | MED-USG-CLEAR-8.5OZ-A | FDA UDI | Class II | Active |
| Delphinus Sequr™ | Breast Interface | FDA UDI | Class II | Active |
| Parker Labs | Transeptic Cleansing Solution | FDA UDI | Class II | Unknown |
| Grass EC3 | Conductive Adhesive Gel | FDA UDI | Class II | Active |
| gammaCore™ | Electrolyte Gel | FDA UDI | Class II | Active |
| Polysonic Ultrasound Lotion | 21-08 | EUDAMEDFDA UDI | Class I | Active |
| Aquasonic Clear Ultrasound Gel | 03-08 | EUDAMEDFDA UDI | Class I | Active |
| Aquasonic 100 Ultrasound Transmission Gel | 01-20 | EUDAMEDFDA UDI | Class I | Active |
| Hemo-Wedge | K790555 | FDA 510(k) | Class I | Active |
| Foramatron Apical Foramen Locator | K811995 | FDA 510(k) | N/A | Active |
| Contact Conductive Adhesive Gel Composition | K852956 | FDA 510(k) | Class II | Active |
| Aquasonic 100 Ultrasound Trans. Gel, | K802146 | FDA 510(k) | Class II | Active |
| Light, Examining, Dental, Ultra Violet | K770685 | FDA 510(k) | Class II | Active |
| Cavidry | K822896 | FDA 510(k) | Class II | Active |
| UltraDrape UGPIV Barrier and Securement (34-15) | K233965 | FDA 510(k) | Class II | Active |
| Neuro Pulse | K841400 | FDA 510(k) | Class II | Active |
| Auro-Brush | K781351 | FDA 510(k) | N/A | Active |
| Crown, Acrylic, Coral Brand, Preformed | K770684 | FDA 510(k) | Class I | Active |
| Cream, Signa | K782055 | FDA 510(k) | Class II | Active |
| Complus Various Forms | K831039 | FDA 510(k) | N/A | Active |
| Accu. Crown Cold Cure | K771527 | FDA 510(k) | Class II | Active |
| Ultra Cover Ultrasound Transducer Probe Covers | K921695 | FDA 510(k) | Class II | Active |
Related Companies
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Authorities
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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. |