Medical Device Manufacturer · US , Mchenry , IL

Holter-Hausner Intl. - FDA 510(k) Cleared Devices

42 submissions · 38 cleared · Since 1978

42

Total

38

Cleared

0

Denied

FDA 510(k) Regulatory Record - Holter-Hausner Intl. Neurology ✕

28 devices

1-12 of 28

Cleared Jul 14, 1988

H-H FLUSHING RESERVOIR

Neurology · 198d

Cleared Jan 19, 1988

H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG

Neurology · 78d

Cleared May 01, 1987

H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS

Neurology · 71d

Cleared Jan 13, 1987

H-H SUBGALEAL TROCAR

Neurology · 15d

Cleared Sep 18, 1985

H-H CATHETER PASSERS(TACL DESIGN

Neurology · 37d

Cleared Sep 18, 1985

H-H ATRIAL CATHETERS & PERITONEAL CATHETERS

Neurology · 37d

Cleared Sep 11, 1985

H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT

Neurology · 30d

Cleared Sep 11, 1985

H-H BURR HOLE CATHETER SUPPORT

Neurology · 21d

Cleared Sep 11, 1985

H-H FIXATION & JOINING CONNECTORS

Neurology · 30d

Cleared Sep 06, 1985

H-H SHUNT INTRODUCER

Neurology · 25d

Cleared Sep 05, 1985

H-H RICKHAM TYPE RESERVOIR

Neurology · 24d

Cleared Sep 05, 1985

H-H FIFTH VENTRICLE

Neurology · 24d