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Smith and Nephew Donjoy, Inc.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K970051	MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE	HCC	1997-07-10	View
510(k)	K963490	PROTECTIVE RESTRAINT - BELTS	FMQ	1996-11-12	View
510(k)	K963492	PROTECTIVE RESTRAINT	FMQ	1996-11-12	View
510(k)	K963489	WHEEL CHAIR ACCESSORY	FMQ	1996-11-12	View
510(k)	K962462	MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR	IPF	1996-09-23	View
510(k)	K955057	MODEL 1100 COLD THERAPY DEVICE	ILO	1996-03-08	View
510(k)	K951350	MUSCLESENSE ELECTROMYOGRAPHY DEVICE	HCC	1995-06-23	View
510(k)	K945687	ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW	HWC	1995-06-22	View
510(k)	K946313	TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER	HRX	1995-03-17	View
510(k)	K945236	AIMS CANNULATED ACL SCREW (7MM DIAMETER)	HWC	1995-02-03	View
510(k)	K932592	BRACE NEUTRALIZER	GZJ	1994-03-18	View
510(k)	K932862	ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW	HWC	1994-03-10	View
510(k)	K934044	ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM	HWC	1994-03-10	View
510(k)	K932320	NEUTRALIZER	GZJ	1993-10-06	View
510(k)	K903823	SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE	KGX	1991-01-16	View

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