Medical Device Manufacturer · US , Carsbad , CA

Smith and Nephew Donjoy, Inc. - FDA 510(k) Cleared Devices

15 submissions · 12 cleared · Since 1991

15

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Smith and Nephew Donjoy, Inc. Neurology ✕

4 devices

1-4 of 4

Cleared Jul 10, 1997

MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE

Neurology · 184d

Cleared Jun 23, 1995

MUSCLESENSE ELECTROMYOGRAPHY DEVICE

Neurology · 91d

Cleared Mar 18, 1994

BRACE NEUTRALIZER

Neurology · 294d

Cleared Oct 06, 1993

Neurology · 148d