Panels › Obstetrics/Gynecology › Product code HIO · Class 1
Sampler, Amniotic Fluid (Amniocentesis Tray)
Regulation 884.1550
0510(k)s in 12 months (20 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in HIO
| Company | 510(k)s | Recalls |
|---|---|---|
| E-Z-Em, Inc. | 3 | 0 |
| Universal Medical Instrument Corp. | 2 | 0 |
| Aptek , Ltd. | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Cameo, Inc. | 1 | 0 |
| Concord/Portex | 1 | 0 |
| Contour Fabricators of Florida, Inc. | 1 | 0 |
| Cook Ob/Gyn | 1 | 0 |
| Critical Specialties, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 1996 | K960203 | G.E. STERILE AMNIOCENTESIS TRAY GE Medical Systems | HIO |
| Mar 12, 1996 | K955679 | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY Contour Fabricators of Florida, Inc. | HIO |
| Sep 1, 1993 | K914419 | AMNIOTEST(TM) Pro-Lab, Inc., CA | HIO |
| Nov 5, 1992 | K922960 | VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE Cameo, Inc. | HIO |
| Apr 27, 1992 | K921738 | SONO-VU US(TM), MODIFICATION E-Z-Em, Inc. | HIO |
| Mar 30, 1992 | K915863 | MEGA AMNIOCENTESIS KIT Mega Medical, Inc. | HIO |
| Jun 24, 1991 | K904583 | SONO-VU US(TM) E-Z-Em, Inc. | HIO |
| Jul 25, 1990 | K901643 | ISOFLO(TM) AMNIOCENTESIS TRAY Healthdyne Cardiovascular, Inc. | HIO |
| Mar 29, 1990 | K900021 | PERCU-SET(TM) E-Z-Em, Inc. | HIO |
| Jan 12, 1990 | K896031 | AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) Concord/Portex | HIO |
| Aug 4, 1989 | K894031 | PHARMASEAL GENETIC AMNIOCENTESIS TRAY Baxter Healthcare Corp | HIO |
| Jul 14, 1989 | K892846 | ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE Cook Ob/Gyn | HIO |
| Apr 7, 1989 | K890463 | ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY Critical Specialties, Inc. | HIO |
| Jul 7, 1986 | K862365 | NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE Swemed Laboratories, Inc., SE | HIO |
| Mar 17, 1986 | K854725 | HURWITZ AMNIOCENTESIS NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic | HIO |
| May 22, 1985 | K850632 | PMS AMNIOCENTESIS TRAY/KIT Professional Medical Services | HIO |
| Jan 31, 1985 | K844558 | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE Universal Medical Instrument Corp. | HIO |
| Jan 18, 1983 | K830019 | AMNIO CENTESES KIT W/NEEDLE Universal Medical Instrument Corp. | HIO |
| Nov 26, 1980 | K802666 | APTEK ULTRASOUND PROCEDURE TRAY Aptek , Ltd. | HIO |
| Dec 17, 1976 | K761230 | AMMOCENTESIS TRAY (KIT) Pharmaseal Div., Baxter Healthcare Corp. | HIO |
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