Medical Device Manufacturer · US , Carsbad , CA

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

15 submissions · 12 cleared · Since 1991

Total

Cleared

Denied

Smith and Nephew Donjoy, Inc. has 12 FDA 510(k) cleared medical devices. Based in Carsbad, US.

Historical record: 12 cleared submissions from 1991 to 1997.

Browse the FDA 510(k) cleared devices submitted by Smith and Nephew Donjoy, Inc. Filter by specialty or product code using the sidebar.

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

15 devices

1-15 of 15

Cleared Jul 10, 1997

MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE

K970051 · HCC

Neurology · 184d

Cleared Nov 12, 1996

WHEEL CHAIR ACCESSORY

K963489 · FMQ

General Hospital · 70d

Cleared Nov 12, 1996

PROTECTIVE RESTRAINT - BELTS

K963490 · FMQ

General Hospital · 70d

Cleared Nov 12, 1996

PROTECTIVE RESTRAINT

K963492 · FMQ

General Hospital · 70d

Cleared Sep 23, 1996

MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR

K962462 · IPF

Physical Medicine · 90d

Cleared Mar 08, 1996

MODEL 1100 COLD THERAPY DEVICE

K955057 · ILO

Physical Medicine · 123d

Cleared Jun 23, 1995

MUSCLESENSE ELECTROMYOGRAPHY DEVICE

K951350 · HCC

Neurology · 91d

Cleared Jun 22, 1995

ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW

K945687 · HWC

Orthopedic · 213d

Cleared Mar 17, 1995

TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER

K946313 · HRX

Orthopedic · 79d

Cleared Feb 03, 1995

AIMS CANNULATED ACL SCREW (7MM DIAMETER)

ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW

K932862 · HWC

Orthopedic · 272d

Cleared Mar 10, 1994

ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM

SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE

K903823 · KGX

General & Plastic Surgery · 149d

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

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