Company ยท US
Parker Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2024. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GYB | Media, Electroconductive | 6 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 |
| EMA | Cement, Dental | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 |
| BSJ | Mask, Gas, Anesthetic | 1 |
| DZN | Instruments, Dental Hand | 1 |
| EAQ | Detector, Ultraviolet | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 |
| EFH | Paper, Articulation | 1 |
| EFN | Cotton, Roll | 1 |
| EGG | Attachment, Precision, All | 1 |
| EGJ | Device, Iontophoresis, Other Uses | 1 |
| EJH | Alloy, Metal, Base | 1 |
| ELZ | Crown, Preformed | 1 |
| FAX | Bougie, Urological | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 |
| KMJ | Lubricant, Patient | 1 |
| MUI | Media, Coupling, Ultrasound | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 15, 2024 | K233965 | UltraDrape UGPIV Barrier and Securement (34-15) Parker Laboratories, Inc. | ITX |
| Mar 14, 1996 | K953673 | ECLIPSE PROBE COVER Parker Laboratories, Inc. | IYO |
| Feb 23, 1995 | K921695 | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS Parker Laboratories, Inc. | ITX |
| Dec 1, 1986 | K864556 | AQUALUBE(TM) Parker Laboratories, Inc. | KMJ |
| Apr 17, 1986 | K861239 | ACRYLIC SOLDER Parker Laboratories, Inc. | EBI |
| Mar 4, 1986 | K855167 | DYNA SYSTEM Parker Laboratories, Inc. | EGG |
| Sep 27, 1985 | K851895 | POLYGEL ULTRASOUND GEL Parker Laboratories, Inc. | IYO |
| Aug 9, 1985 | K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION Parker Laboratories, Inc. | GYB |
| Jun 15, 1984 | K841400 | NEURO PULSE Parker Laboratories, Inc. | GZJ |
| Apr 17, 1984 | K840548 | RESIL Parker Laboratories, Inc. | EBI |
| May 27, 1983 | K831039 | COMPLUS VARIOUS FORMS Parker Laboratories, Inc. | |
| Nov 3, 1982 | K822711 | ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL Parker Laboratories, Inc. | FAX |
| Oct 22, 1982 | K822896 | CAVIDRY Parker Laboratories, Inc. | EJH |
| Apr 16, 1982 | K827296 | POLYSONIC ULTRASOUND LOTION Parker Laboratories, Inc. | MUI |
| Sep 21, 1981 | K811995 | FORAMATRON APICAL FORAMEN LOCATOR Parker Laboratories, Inc. | |
| Oct 10, 1980 | K802146 | AQUASONIC 100 ULTRASOUND TRANS. GEL, Parker Laboratories, Inc. | IYO |
| Jan 23, 1980 | K800060 | PROVIT Parker Laboratories, Inc. | EMA |
| Jan 17, 1980 | K790555 | HEMO-WEDGE Parker Laboratories, Inc. | DZN |
| Dec 6, 1979 | K792391 | COTTON ROLL COMPRESSION CAPS Parker Laboratories, Inc. | EFN |
| Sep 17, 1979 | K791013 | SPECTRA R PAD Parker Laboratories, Inc. | GYB |
| May 25, 1979 | K790638 | ACCUTRON POLLUTION REDUCER Parker Laboratories, Inc. | BSJ |
| Mar 21, 1979 | K782055 | CREAM, SIGNA Parker Laboratories, Inc. | GYB |
| Dec 4, 1978 | K781351 | AURO-BRUSH Parker Laboratories, Inc. | |
| Jul 27, 1978 | K780973 | SIGNAPAD Parker Laboratories, Inc. | GYB |
| Aug 16, 1977 | K771527 | ACCU. CROWN COLD CURE Parker Laboratories, Inc. | EBG |
| Jul 15, 1977 | K771130 | DESENSITRON Parker Laboratories, Inc. | EGJ |
| Jun 20, 1977 | K771011 | ARTICULATING PAPER Parker Laboratories, Inc. | EFH |
| Apr 26, 1977 | K770685 | LIGHT, EXAMINING, DENTAL, ULTRA VIOLET Parker Laboratories, Inc. | EAQ |
| Apr 26, 1977 | K770684 | CROWN, ACRYLIC, CORAL BRAND, PREFORMED Parker Laboratories, Inc. | ELZ |
| Jan 25, 1977 | K770067 | CYANOBOND Parker Laboratories, Inc. | EMA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2024 | Parker Laboratories, Inc. Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme. Open, Classified |
GYB | None listed |
| Feb 29, 2024 | Parker Laboratories, Inc. Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each. Open, Classified |
GYB | K852956 |
| Apr 13, 2017 | Parker Laboratories, Inc. Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case Terminated |
IYO | K802146 |
| Oct 29, 2014 | Parker Laboratories, Inc. Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasou Terminated |
IYO | K953673 |