Product code HFS— General Hospital

FDA has cleared 12 devices under product code HFS between 1981 and 1994, filed by 10 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19944 clearances
• 19932 clearances
• 19862 clearances
• 19851 clearance
• 19841 clearance
• 19831 clearance
• 19811 clearance

• Medela, Inc.2 clearances
• Marshall Baby Products2 clearances
• Unicare Medical Products, Inc.1 clearance
• Sherwood Medical Co.1 clearance
• Reliance Products Corp.1 clearance
• Prolac, Inc.1 clearance
• O'Donnell, Byrne & Williams1 clearance
• Neonatal Corp.1 clearance
• Mali, Inc.1 clearance
• Avent America, Inc.1 clearance

• K944117 — AVENT NIPPLE SHIELDAvent America, Inc.·1994-10-05
• K944177 — BREAST SHELLO'Donnell, Byrne & Williams·1994-10-05
• K935340 — COMFORT PLUS NIPPLE SHIELDSMarshall Baby Products·1994-01-21
• K935341 — COMFORT PLUS BREAST SHELLSMarshall Baby Products·1994-01-21
• K930238 — BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDSProlac, Inc.·1993-08-16
• K923577 — BREAST SHELLSMedela, Inc.·1993-01-22
• K864176 — GENTLE FEELMali, Inc.·1986-11-04
• K861608 — UNICARE BREAST SHELLSUnicare Medical Products, Inc.·1986-07-15
• K853176 — CANNON BABYSAFE NIPPLE SHIELDSMedela, Inc.·1985-08-22
• K840877 — ARGYLE ENTERNAL FEEDING BAG W/ADMINSherwood Medical Co.·1984-06-28
• K833450 — NUK BREAST SHIELDReliance Products Corp.·1983-11-21
• K811364 — AXICARE BREAST SHELLNeonatal Corp.·1981-08-03