HIO · Class I · 21 CFR 884.1550

FDA Product Code HIO: Sampler, Amniotic Fluid (amniocentesis Tray)

Leading manufacturers include E-Z-Em, Inc., Universal Medical Instrument Corp. and Critical Specialties, Inc..

20
Total
20
Cleared
113d
Avg days
1976
Since

FDA 510(k) Cleared Sampler, Amniotic Fluid (amniocentesis Tray) Devices (Product Code HIO)

20 devices
1–20 of 20
Cleared Mar 14, 1996
G.E. STERILE AMNIOCENTESIS TRAY
K960203
GE Medical Systems
Obstetrics & Gynecology · 58d
Cleared Mar 12, 1996
RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
K955679
Contour Fabricators of Florida, Inc.
Obstetrics & Gynecology · 89d
Cleared Sep 01, 1993
AMNIOTEST(TM)
K914419
Pro-Lab, Inc.
Chemistry · 699d
Cleared Nov 05, 1992
VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
K922960
Cameo, Inc.
Obstetrics & Gynecology · 140d
Cleared Apr 27, 1992
SONO-VU US(TM), MODIFICATION
K921738
E-Z-Em, Inc.
Radiology · 89d
Cleared Mar 30, 1992
MEGA AMNIOCENTESIS KIT
K915863
Mega Medical, Inc.
Obstetrics & Gynecology · 90d
Cleared Jun 24, 1991
SONO-VU US(TM)
K904583
E-Z-Em, Inc.
Radiology · 258d
Cleared Jul 25, 1990
ISOFLO(TM) AMNIOCENTESIS TRAY
K901643
Healthdyne Cardiovascular, Inc.
Obstetrics & Gynecology · 107d
Cleared Mar 29, 1990
PERCU-SET(TM)
K900021
E-Z-Em, Inc.
Obstetrics & Gynecology · 86d
Cleared Jan 12, 1990
AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)
K896031
Concord/Portex
Obstetrics & Gynecology · 88d
Cleared Aug 04, 1989
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K894031
Baxter Healthcare Corp
Obstetrics & Gynecology · 59d
Cleared Jul 14, 1989
ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
K892846
Cook Ob/Gyn
Obstetrics & Gynecology · 87d
Cleared Apr 07, 1989
ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY
K890463
Critical Specialties, Inc.
Obstetrics & Gynecology · 67d
Cleared Jul 07, 1986
NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE
K862365
Swemed Laboratories, Inc.
Obstetrics & Gynecology · 13d
Cleared Mar 17, 1986
HURWITZ AMNIOCENTESIS NEEDLE
K854725
Bd Becton Dickinson Vacutainer Systems Preanalytic
Obstetrics & Gynecology · 115d
Cleared May 22, 1985
PMS AMNIOCENTESIS TRAY/KIT
K850632
Professional Medical Services
Obstetrics & Gynecology · 92d
Cleared Jan 31, 1985
UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
K844558
Universal Medical Instrument Corp.
Obstetrics & Gynecology · 71d
Cleared Jan 18, 1983
AMNIO CENTESES KIT W/NEEDLE
K830019
Universal Medical Instrument Corp.
Obstetrics & Gynecology · 14d
Cleared Nov 26, 1980
APTEK ULTRASOUND PROCEDURE TRAY
K802666
Aptek , Ltd.
Obstetrics & Gynecology · 29d
Cleared Dec 17, 1976
AMMOCENTESIS TRAY (KIT)
K761230
Pharmaseal Div., Baxter Healthcare Corp.
Obstetrics & Gynecology · 7d

About Product Code HIO - Regulatory Context