Medical Device Manufacturer · US , Mchenry , IL

Burke, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1984

Recent clearances: FUSION, SCOUT, PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)

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7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Burke, Inc. Physical Medicine ✕

7 devices

1-7 of 7

Cleared Aug 01, 2006

Physical Medicine · 26d

Cleared Dec 24, 2002

Physical Medicine · 25d

Cleared Aug 31, 1998

Physical Medicine · 73d

Cleared Jul 17, 1997

PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)

Physical Medicine · 244d

Cleared Jul 19, 1991

CONCEPT MODEL 5200 THERMAL THERAPY SYSTEM

Physical Medicine · 79d

Cleared Jun 22, 1989

COLD/HOT FLUID RADIATION PAD NEUTECH

Physical Medicine · 35d

Cleared Jan 30, 1984

PACESAVER & SCOUT

Physical Medicine · 40d