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

42 devices

26-42 of 42

Cleared May 14, 1984

H-H SHUNT PASSERS

Neurology · 28d

Cleared Mar 06, 1984

HH SUBCUTANEOUS ACCESS PORT

General Hospital · 140d

Cleared Apr 08, 1983

H-H IN-LINE VALVED CATHETER 2 TYPES

Neurology · 18d

Cleared Jul 22, 1982

H-H NERVE ROOT RETRACTOR

Neurology · 10d

Cleared May 28, 1982

H-H ALIMENTATION CATHETERS

Gastroenterology & Urology · 46d

Cleared Mar 01, 1982

H-H RICKHAM TYPE RESERVOIR

Neurology · 24d

Cleared Feb 24, 1982

H-H BURR HOLE CATHETER SUPPORT

Neurology · 19d

Cleared Jan 31, 1980

H-H FIFTH VENTRICLE

Neurology · 6d

Cleared Dec 31, 1979

H-H SHUNT INTRODUCER

Neurology · 11d

Cleared Aug 03, 1979

H-H SLOTTED CATHETER-RESERVOIR

Neurology · 52d

Cleared Aug 03, 1979

H-H SLOTTED VENTRICULAR CATHETER

Neurology · 52d

Cleared May 11, 1979

H-H FIXATION AND JOINING CONNECTORS

Neurology · 8d

Cleared Jan 26, 1979

VALVE, H-H CRUCIFORM SLIT

Neurology · 2d

Cleared Jan 15, 1979

CATHETERS, H-H VENTRICULAR

Neurology · 27d

Cleared Dec 04, 1978

TENDON ROD MODEL OR41PO3-6

Orthopedic · 17d

Cleared Nov 14, 1978

CATHETERS, H-H ATRIAL AND PERITONEAL

Neurology · 29d

Cleared Mar 17, 1978

PASSIVE TENDON IMPLANT

Orthopedic · 21d