Medical Device Manufacturer · US , Walker , MI

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

12 submissions · 12 cleared · Since 1981

12

Total

12

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared Nov 26, 1986

Cardiovascular · 98d

Cleared Aug 23, 1984

TX-2 THERMAL DILUTION CARDIAC OUTPUT

Cardiovascular · 253d

Cleared Jul 13, 1984

POLYURETHANE THERMAL DILUTION CATHET

Cardiovascular · 67d