Medical Device Manufacturer · US , Mchenry , IL

Howmedica Corp. - FDA 510(k) Cleared Devices

373 submissions · 325 cleared · Since 1976
373
Total
325
Cleared
0
Denied
FDA 510(k) Regulatory Record - Howmedica Corp. Gastroenterology & Urology
17 devices
1-17 of 17
Cleared Jan 18, 1985
UNITED SKIN BARRIER PASTE
K844341 · EZR
Gastroenterology & Urology · 71d
Cleared Nov 29, 1984
UNITED SKIN BARRIERS
K844046 · EXB
Gastroenterology & Urology · 43d
Cleared Apr 04, 1984
BANGORT LIFESTYLE COLOSTOMY POUCHES
K841029 · EXB
Gastroenterology & Urology · 23d
Cleared Dec 07, 1982
UNI-TIP COLOSTOMY IRRIGATION CONE
K823274 · EXD
Gastroenterology & Urology · 34d
Cleared Nov 17, 1981
WOUND DRAINAGE MANAGEMENT SYSTEMS
K813080 · EXB
Gastroenterology & Urology · 15d
Cleared Jun 02, 1981
FORMULATION CHANGE IN UNITED SKIN BARR
K810726 · EXB
Gastroenterology & Urology · 77d
Cleared Jul 28, 1980
SUPER BANISH DEODORANT
K801471 · EXB
Gastroenterology & Urology · 34d
Cleared Jul 28, 1980
NASO-GARD NASOGASTRIC TUBE HOLDER
K801511 · KNT
Gastroenterology & Urology · 27d
Cleared Dec 10, 1979
BONGORT ODOR BARRIER DRAIN
K792381 · EXB
Gastroenterology & Urology · 14d
Cleared Nov 13, 1979
FEATHER-LITE URINARY DIV. POUCH
K792139 · EXB
Gastroenterology & Urology · 22d
Cleared Jul 15, 1977
UNITED SKIN BARRIER
K770982 · EXE
Gastroenterology & Urology · 45d
Cleared Jun 28, 1977
POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE
K770826 · FON
Gastroenterology & Urology · 54d
Cleared Mar 15, 1977
KARAYA GUM POWDER, OSTOMY
K770408 · EZK
Gastroenterology & Urology · 11d
Cleared Mar 07, 1977
OSTOMY KARAYA GUM POWDER
K761340 · EZR
Gastroenterology & Urology · 69d
Cleared Feb 15, 1977
KARAYA GUM PRODUCTS - PROCESS CHANGE
K761319 · EZR
Gastroenterology & Urology · 50d
Cleared Dec 02, 1976
BONGORT ILEOSTOMY POUCH
K760878 · EXB
Gastroenterology & Urology · 42d
Cleared Oct 15, 1976
BONGORT SPECIAL ODORPROOF DRAIN
K760735 · EXB
Gastroenterology & Urology · 17d
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