Parker Laboratories, Inc.
Medical device manufacturer in Fairfield, NJ.
30510(k) clearances
0PMA approvals
4recalls
Device types
- GYB Media, Electroconductive 4
- IYO System, Imaging, Pulsed Echo, Ultrasonic 3
- ITX Transducer, Ultrasonic, Diagnostic 2
- EBI Resin, Denture, Relining, Repairing, Rebasing 2
- EMA Cement, Dental 2
- DZN Instruments, Dental Hand 1
- KMJ Lubricant, Patient 1
- EGG Attachment, Precision, All 1
- GZJ Stimulator, Nerve, Transcutaneous, For Pain… 1
- FAX Bougie, Urological 1
- EJH Alloy, Metal, Base 1
- MUI Media, Coupling, Ultrasound 1
- EFN Cotton, Roll 1
- BSJ Mask, Gas, Anesthetic 1
- EBG Crown And Bridge, Temporary, Resin 1
- EGJ Device, Iontophoresis, Other Uses 1
- EFH Paper, Articulation 1
- EAQ Detector, Ultraviolet 1
- ELZ Crown, Preformed 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15)ITX · Traditional | 08/15/2024SE |
| K953673 | Eclipse Probe CoverIYO · Traditional | 03/14/1996SE |
| K921695 | Ultra Cover Ultrasound Transducer Probe CoversITX · Traditional | 02/23/1995SE |
| K864556 | Aqualube(Tm)KMJ · Traditional | 12/01/1986SE |
| K861239 | Acrylic SolderEBI · Traditional | 04/17/1986SE |
| K855167 | Dyna SystemEGG · Traditional | 03/04/1986SE |
| K851895 | Polygel Ultrasound GelIYO · Traditional | 09/27/1985SE |
| K852956 | Contact Conductive Adhesive Gel CompositionGYB · Traditional | 08/09/1985SE |
| K841400 | Neuro PulseGZJ · Traditional | 06/15/1984SE |
| K840548 | ResilEBI · Traditional | 04/17/1984SE |
| K831039 | Complus Various Forms · Traditional | 05/27/1983SE |
| K822711 | Anti-Mist, Anti-Fog Eyeglass & DentalFAX · Traditional | 11/03/1982SE |
| K822896 | CavidryEJH · Traditional | 10/22/1982SE |
| K827296 | Polysonic Ultrasound LotionMUI · Traditional | 04/16/1982SE |
| K811995 | Foramatron Apical Foramen Locator · Traditional | 09/21/1981SE |
| K802146 | Aquasonic 100 Ultrasound Trans. Gel,IYO · Traditional | 10/10/1980SE |
| K800060 | ProvitEMA · Traditional | 01/23/1980SE |
| K790555 | Hemo-WedgeDZN · Traditional | 01/17/1980SE |
| K792391 | Cotton Roll Compression CapsEFN · Traditional | 12/06/1979SE |
| K791013 | Spectra R PadGYB · Traditional | 09/17/1979SE |
| K790638 | Accutron Pollution ReducerBSJ · Traditional | 05/25/1979SE |
| K782055 | Cream, SignaGYB · Traditional | 03/21/1979SE |
| K781351 | Auro-Brush · Traditional | 12/04/1978SE |
| K780973 | SignapadGYB · Traditional | 07/27/1978SE |
| K771527 | Accu. Crown Cold CureEBG · Traditional | 08/16/1977SE |
| K771130 | DesensitronEGJ · Traditional | 07/15/1977SE |
| K771011 | Articulating PaperEFH · Traditional | 06/20/1977SE |
| K770685 | Light, Examining, Dental, Ultra VioletEAQ · Traditional | 04/26/1977SE |
| K770684 | Crown, Acrylic, Coral Brand, PreformedELZ · Traditional | 04/26/1977SE |
| K770067 | CyanobondEMA · Traditional | 01/25/1977SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1604-2024 Class II | Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.Product demonstrates low viscosity. | 03/22/2024Open, Classified |
| Z-1204-2024 Class II | Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes…Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60. | 01/22/2024Open, Classified |
| Z-1777-2018 Class II | Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400…There is a potential for the gel packets to have leaks in the packet seal. | 04/13/2017Terminated |
| Z-0145-2015 Class II | Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size:…Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the… | 08/06/2014Terminated |