Precision Dynamics Corp.
Medical device manufacturer in Valencia, CA.
26510(k) clearances
0PMA approvals
1recalls
Device types
- JTW System, Transport, Aerobic 9
- JSM Culture Media, Non-Propagating Transport 5
- HFW Clamp, Umbilical 3
- FZZ Marker, Skin 2
- KNW Instrument, Biopsy 2
- GDM Needle, Aspiration And Injection, Reusable 1
- LRP Tray, Surgical 1
- KOT Carboxymethylcellulose Sodium Or Polyvinyl… 1
- HFM Monitor, Uterine Contraction, External (For… 1
- IZH System, X-Ray, Mammographic 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K161920 | Comfort CoverIZH · Traditional | 07/15/2016SE |
| K020718 | Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-SterileHFW · Traditional | 06/03/2002SE |
| K994353 | Secureline Disposable Fetal Monitoring Straps #3860 and #3565HFM · Traditional | 03/22/2000SE |
| K994263 | Securline Umbilical Cord Clamp Clipper #3540HFW · Traditional | 01/24/2000SE |
| K990737 | 'Ecurline Umbilical Cord Clamp #3500HFW · Traditional | 04/06/1999SE |
| K884357 | Precision Bioport Collection & Transport SystemKOT · Traditional | 11/01/1988SE |
| K882580 | Mechanical Change in In-Vitro Micro DeviceJTW · Traditional | 07/08/1988SE |
| K874665 | Securline Fine Needle Aspiration Biopsy TrayLRP · Traditional | 01/20/1988SESD |
| K873369 | Securline Franseene NeedleKNW · Traditional | 10/20/1987SE |
| K872507 | Precision Culture C.A.T.S. Collect/Trans HSV I/IiJSM · Traditional | 07/09/1987SE |
| K863164 | Agar Reduction in Formula for PDC 110 & 310 MediaJSM · Traditional | 08/27/1986SE |
| K851364 | Franzen Needle Guide for Transrectal Prostate BiopKNW · Traditional | 04/22/1985SE |
| K844634 | PDC 104 & PDC 304 Style Culture Collection & TransJSM · Traditional | 01/30/1985SE |
| K844865 | Securline Surgical Skin Marker 1000FZZ · Traditional | 01/14/1985SE |
| K844370 | BBL Port-A-Cul 21627 Single Swab Culture CollectJSM · Traditional | 01/04/1985SE |
| K844369 | BBL Port-A-Cul 21628 Double Swab Sulture CollectioJSM · Traditional | 01/04/1985SE |
| K840820 | Securline Surgical Skin Marker 1000FZZ · Traditional | 04/25/1984SE |
| K830235 | Franzen Needle GuideGDM · Traditional | 02/23/1983SE |
| K791953 | PDC 304 Double Swab Culture CollectionJTW · Traditional | 10/30/1979SE |
| K791924 | PDC 104 Single Swab Culture CollectionJTW · Traditional | 10/17/1979SE |
| K772209 | Culture Collec. Trans. Sys., Double DryJTW · Traditional | 12/20/1977SE |
| K772207 | Culture Collec. Trans. Sys., Single WetJTW · Traditional | 12/20/1977SE |
| K772210 | Culture Collec. Trans. Sys., Double WetJTW · Traditional | 12/09/1977SE |
| K772208 | Culture Collec. Trans. Sys., Single DryJTW · Traditional | 12/09/1977SE |
| K772206 | Culture Collec. Trans. Sys., Single WetJTW · Traditional | 12/09/1977SE |
| K772205 | Culture Collec. Trans. Sys., Double WetJTW · Traditional | 12/09/1977SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1872-2013 Class II | Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part…PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers… | 07/10/2013Terminated |