HDY · Class II · 21 CFR 884.4260

FDA Product Code HDY: Dilator, Cervical, Hygroscopic-laminaria

Leading manufacturers include A & A Medical, Inc., Quality Medical Solusions, LLC and Atad Developments , Ltd..

11
Total
11
Cleared
120d
Avg days
1979
Since

FDA 510(k) Cleared Dilator, Cervical, Hygroscopic-laminaria Devices (Product Code HDY)

11 devices
1–11 of 11
Cleared Jan 18, 2005
ATAD ARD CATHETER
K040625
Atad Developments , Ltd.
Obstetrics & Gynecology · 315d
Cleared Jun 25, 2002
LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
K021012
Quality Medical Solusions, LLC
Obstetrics & Gynecology · 88d
Cleared Jul 09, 2001
MMODIFICATION TO LAMINARIA
K011512
A & A Medical, Inc.
Obstetrics & Gynecology · 54d
Cleared May 22, 1996
LAMINARIA
K955072
Cti Corp., Ltd.
Obstetrics & Gynecology · 198d
Cleared Jun 14, 1989
LAMINARIA TENT
K892220
Berkeley Medevices
Obstetrics & Gynecology · 72d
Cleared Aug 10, 1988
LAMINARIA CUREX
K881295
Harold W. Berger Co.
Obstetrics & Gynecology · 135d
Cleared May 23, 1988
LAMINARIA
K881312
Busse Hospital Disposables, Inc.
Obstetrics & Gynecology · 56d
Cleared May 06, 1988
LAMINARIA
K880196
Medgyn Products, Inc.
Obstetrics & Gynecology · 101d
Cleared May 01, 1985
SUN MEDICAL LAMINARIA CERVICAL DILATOR
K845006
Sun Medical, Inc.
Obstetrics & Gynecology · 126d
Cleared Feb 04, 1984
LAMINARIA JAPONICA CERVICAL DILATOR
K833068
Medi-Spec
Obstetrics & Gynecology · 149d
Cleared Jan 03, 1979
DILATOR, MIZUTANI LAMINARIA TENT
K782067
British Marketing Ent., Ltd.
Obstetrics & Gynecology · 21d

About Product Code HDY - Regulatory Context