Medical Device Manufacturer · US , Mchenry , IL

Hollister, Inc. - FDA 510(k) Cleared Devices

85 submissions · 78 cleared · Since 1977

Recent clearances: INSTAFLO BOWEL CATHETER SYSTEM KIT, INSTAFLO BOWEL CATHETER SYSTEM KIT, VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,

85

Total

78

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hollister, Inc. General & Plastic Surgery ✕

14 devices

1-12 of 14

Cleared May 17, 2004

RESTORE WOUND CLEANSER

General & Plastic Surgery · 52d

Cleared Oct 14, 1999

SIMPLICARE TRANSPARENT WOUND DRESSING

General & Plastic Surgery · 188d

Cleared Feb 20, 1998

SIMPLICARE THIN FILM WOUND DRESSINGS

General & Plastic Surgery · 31d

Cleared Oct 23, 1995

RECLOSABLE WOUND COVER

General & Plastic Surgery · 18d

Cleared Oct 06, 1995

HOLLISTER HYDROCOLLOID WOUND DRESSING

General & Plastic Surgery · 25d

Cleared Jul 11, 1995

HOLLISTER HYDROCOLLOID WOUND DRESSINGS

General & Plastic Surgery · 132d

Cleared Aug 06, 1992

HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE

General & Plastic Surgery · 59d

Cleared Sep 25, 1991

INCARE HOT/ICE ABSORBENT INTERFACE

General & Plastic Surgery · 78d

Cleared Apr 12, 1991

INCARE PINSITE DRESSING

General & Plastic Surgery · 143d

Cleared Jun 22, 1988

HYDROCOLLOID DRESSING FOR PSORIASIS

General & Plastic Surgery · 103d

Cleared Aug 04, 1986

HOLLISTER WOUND CARE BARRIER

General & Plastic Surgery · 28d

Cleared Oct 15, 1982

ADHESIVE WOUND COVER FILM

General & Plastic Surgery · 92d