Medical Device Manufacturer · US , Mansfield , MA

Kendall Healthcare Products Co. Div.Of Tyco Health - FDA 510(k) Clear...

66 submissions · 50 cleared · Since 1989

Recent clearances: KENDALL CURITY IODOFORM PACKING STRIP, KENDALL CURITY PETROLATUM GAUZE, KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)

66

Total

50

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kendall Healthcare Products Co. Div.Of Tyco Health Cardiovascular ✕

6 devices

1-6 of 6

Cleared Sep 13, 1993

SCD(R) CONTROLLER

Cardiovascular · 69d

Cleared Aug 06, 1993

KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICE

Cardiovascular · 57d

Cleared Mar 13, 1990

CURITY(R) PERCUTANEOUS CATHETERS

Cardiovascular · 152d

Cleared Nov 30, 1989

SCD KNEE IMMOBILIZER

Cardiovascular · 99d

Cleared Nov 29, 1989

KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN

Cardiovascular · 89d

Cleared May 19, 1989

KENDALL SCD THERAPEUTIC SYSTEM

Cardiovascular · 84d