Company ยท US
Precision Dynamics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2016. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JTW | System, Transport, Aerobic | 9 |
| JSM | Culture Media, Non-Propagating Transport | 5 |
| FZZ | Marker, Skin | 3 |
| HFW | Clamp, Umbilical | 3 |
| KNW | Instrument, Biopsy | 2 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 1 |
| IZH | System, X-Ray, Mammographic | 1 |
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | 1 |
| LRP | Tray, Surgical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2016 | K161920 | Comfort Cover Precision Dynamics Corporation | IZH |
| Jun 3, 2002 | K020718 | SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE Precision Dynamics Corp. | HFW |
| Mar 22, 2000 | K994353 | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 Precision Dynamics Corp. | HFM |
| Jan 24, 2000 | K994263 | SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 Precision Dynamics Corp. | HFW |
| Apr 6, 1999 | K990737 | 'ECURLINE UMBILICAL CORD CLAMP #3500 Precision Dynamics Corp. | HFW |
| Nov 1, 1988 | K884357 | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM Precision Dynamics Corp. | KOT |
| Jul 8, 1988 | K882580 | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE Precision Dynamics Corp. | JTW |
| Jan 20, 1988 | K874665 | SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY Precision Dynamics Corp. | LRP |
| Oct 20, 1987 | K873369 | SECURLINE FRANSEENE NEEDLE Precision Dynamics Corp. | KNW |
| Jul 9, 1987 | K872507 | PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II Precision Dynamics Corp. | JSM |
| Aug 27, 1986 | K863164 | AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA Precision Dynamics Corp. | JSM |
| Apr 22, 1985 | K851364 | FRANZEN NEEDLE GUIDE FOR TRANSRECTAL PROSTATE BIOP Precision Dynamics Corp. | KNW |
| Jan 30, 1985 | K844634 | PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS Precision Dynamics Corp. | JSM |
| Jan 14, 1985 | K844865 | SECURLINE SURGICAL SKIN MARKER 1000 Precision Dynamics Corp. | FZZ |
| Jan 4, 1985 | K844370 | BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT Precision Dynamics Corp. | JSM |
| Jan 4, 1985 | K844369 | BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO Precision Dynamics Corp. | JSM |
| Apr 25, 1984 | K840820 | SECURLINE SURGICAL SKIN MARKER 1000 Precision Dynamics Corp. | FZZ |
| Feb 23, 1983 | K830235 | FRANZEN NEEDLE GUIDE Precision Dynamics Corp. | GDM |
| Oct 30, 1979 | K791953 | PDC 304 DOUBLE SWAB CULTURE COLLECTION Precision Dynamics Corp. | JTW |
| Oct 17, 1979 | K791924 | PDC 104 SINGLE SWAB CULTURE COLLECTION Precision Dynamics Corp. | JTW |
| Dec 20, 1977 | K772209 | CULTURE COLLEC. TRANS. SYS., DOUBLE DRY Precision Dynamics Corp. | JTW |
| Dec 20, 1977 | K772207 | CULTURE COLLEC. TRANS. SYS., SINGLE WET Precision Dynamics Corp. | JTW |
| Dec 9, 1977 | K772210 | CULTURE COLLEC. TRANS. SYS., DOUBLE WET Precision Dynamics Corp. | JTW |
| Dec 9, 1977 | K772208 | CULTURE COLLEC. TRANS. SYS., SINGLE DRY Precision Dynamics Corp. | JTW |
| Dec 9, 1977 | K772206 | CULTURE COLLEC. TRANS. SYS., SINGLE WET Precision Dynamics Corp. | JTW |
| Dec 9, 1977 | K772205 | CULTURE COLLEC. TRANS. SYS., DOUBLE WET Precision Dynamics Corp. | JTW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 2, 2013 | Precision Dynamics Corporation Non-sterile Viscot Surgical Skin Markers
Part Number 1437-100
Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e Terminated |
FZZ | None listed |