HDW · Class II · 21 CFR 884.5350

FDA Product Code HDW: Diaphragm, Contraceptive (and Accessories)

Leading manufacturers include CooperSurgical, Inc., Johnson & Johnson Produtos Profissionais Ltda. and Kessel Medintim GmbH.

4
Total
4
Cleared
226d
Avg days
1980
Since

FDA 510(k) Cleared Diaphragm, Contraceptive (and Accessories) Devices (Product Code HDW)

4 devices
1–4 of 4
Cleared Aug 26, 2014
CAYA CONTOURED DIAPHRAGM
K140305
Kessel Medintim GmbH
Obstetrics & Gynecology · 200d
Cleared Aug 25, 2008
ORTHO ALL-FLEX DIAPHRAGM
K080040
Johnson & Johnson Produtos Profissionais Ltda.
Obstetrics & Gynecology · 231d
Cleared Jan 23, 2008
MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS
K063223
CooperSurgical, Inc.
Obstetrics & Gynecology · 456d
Cleared Feb 11, 1980
ONCE TM
K800162
G.D. Searle and Co.
Obstetrics & Gynecology · 17d

About Product Code HDW - Regulatory Context