Parker Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 30
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1604-2024 | Class II | Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme. | March 22, 2024 |
| Z-1204-2024 | Class II | Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tub | January 22, 2024 |
| D-1093-2023 | Class II | Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775-054-01), b)2 fl. oz. t | August 2, 2023 |
| D-1092-2023 | Class II | Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tu | August 2, 2023 |
| D-1091-2023 | Class II | Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) | August 2, 2023 |
| D-1090-2023 | Class II | Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz | August 2, 2023 |
| D-1089-2023 | Class II | Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottl | August 2, 2023 |
| Z-1777-2018 | Class II | Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case | April 13, 2017 |
| Z-0145-2015 | Class II | Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5" | August 6, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | August 15, 2024 |
| K953673 | ECLIPSE PROBE COVER | March 14, 1996 |
| K921695 | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS | February 23, 1995 |
| K864556 | AQUALUBE(TM) | December 1, 1986 |
| K861239 | ACRYLIC SOLDER | April 17, 1986 |
| K855167 | DYNA SYSTEM | March 4, 1986 |
| K851895 | POLYGEL ULTRASOUND GEL | September 27, 1985 |
| K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION | August 9, 1985 |
| K841400 | NEURO PULSE | June 15, 1984 |
| K840548 | RESIL | April 17, 1984 |
| K831039 | COMPLUS VARIOUS FORMS | May 27, 1983 |
| K822711 | ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL | November 3, 1982 |
| K822896 | CAVIDRY | October 22, 1982 |
| K827296 | POLYSONIC ULTRASOUND LOTION | April 16, 1982 |
| K811995 | FORAMATRON APICAL FORAMEN LOCATOR | September 21, 1981 |
| K802146 | AQUASONIC 100 ULTRASOUND TRANS. GEL, | October 10, 1980 |
| K800060 | PROVIT | January 23, 1980 |
| K790555 | HEMO-WEDGE | January 17, 1980 |
| K792391 | COTTON ROLL COMPRESSION CAPS | December 6, 1979 |
| K791013 | SPECTRA R PAD | September 17, 1979 |