Medical Device Manufacturer · US , Walker , MI

Waters Instruments, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1981

Total

Cleared

Denied

Waters Instruments, Inc. has 12 FDA 510(k) cleared medical devices. Based in Walker, US.

Historical record: 12 cleared submissions from 1981 to 2006. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Waters Instruments, Inc. Filter by specialty or product code using the sidebar.

Waters Instruments, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Waters Instruments, Inc.

12 devices

1-12 of 12

Cleared Jan 17, 2006

RM3 RENAL PRESERVATION SYSTEM

K053169 · KDK

Gastroenterology & Urology · 64d

Cleared Oct 22, 2004

RM3 RENAL PRESERVATION SYSTEM

K042224 · KDN

Gastroenterology & Urology · 66d

Cleared Jul 29, 1997

RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT

K971571 · KDN

Gastroenterology & Urology · 90d

Cleared Oct 23, 1992

OXICOM-2100

K921519 · DQA

Anesthesiology · 206d

Cleared Aug 26, 1991

OXICOMPLUS

K911207 · DQA

Anesthesiology · 160d

Anesthesiology · 128d

Cleared Aug 23, 1984

TX-2 THERMAL DILUTION CARDIAC OUTPUT

K834408 · DXG

Cardiovascular · 253d

Cleared Jul 13, 1984

POLYURETHANE THERMAL DILUTION CATHET

K841876 · DYG

Cardiovascular · 67d

Cleared Apr 09, 1982

WATERS ILEOSTOMY VALVE

K813585 · KNT

Gastroenterology & Urology · 102d

Cleared Dec 31, 1981

WATERS ILEAL RESERVOIR CATHETER

K813494 · KPH

Gastroenterology & Urology · 17d

Waters Instruments, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Waters Instruments, Inc.

Filters