HFS · Class I · 21 CFR 880.5630

FDA Product Code HFS: Shield, Nipple

Leading manufacturers include Medela, Inc., Marshall Baby Products and Neonatal Corp..

12
Total
12
Cleared
84d
Avg days
1981
Since

FDA 510(k) Cleared Shield, Nipple Devices (Product Code HFS)

12 devices
1–12 of 12
Cleared Oct 05, 1994
AVENT NIPPLE SHIELD
K944117
Avent America, Inc.
General Hospital · 43d
Cleared Oct 05, 1994
BREAST SHELL
K944177
O'Donnell, Byrne & Williams
General Hospital · 40d
Cleared Jan 21, 1994
COMFORT PLUS NIPPLE SHIELDS
K935340
Marshall Baby Products
General Hospital · 77d
Cleared Jan 21, 1994
COMFORT PLUS BREAST SHELLS
K935341
Marshall Baby Products
General Hospital · 77d
Cleared Aug 16, 1993
BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS
K930238
Prolac, Inc.
General Hospital · 209d
Cleared Jan 22, 1993
BREAST SHELLS
K923577
Medela, Inc.
General Hospital · 186d
Cleared Nov 04, 1986
GENTLE FEEL
K864176
Mali, Inc.
General Hospital · 11d
Cleared Jul 15, 1986
UNICARE BREAST SHELLS
K861608
Unicare Medical Products, Inc.
General Hospital · 77d
Cleared Aug 22, 1985
CANNON BABYSAFE NIPPLE SHIELDS
K853176
Medela, Inc.
General Hospital · 41d
Cleared Jun 28, 1984
ARGYLE ENTERNAL FEEDING BAG W/ADMIN
K840877
Sherwood Medical Co.
General Hospital · 122d
Cleared Nov 21, 1983
NUK BREAST SHIELD
K833450
Reliance Products Corp.
General Hospital · 47d
Cleared Aug 03, 1981
AXICARE BREAST SHELL
K811364
Neonatal Corp.
General Hospital · 81d

About Product Code HFS - Regulatory Context