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Smith And Nephew Donjoy, Inc.

FDA Regulatory Profile

Smith And Nephew Donjoy, Inc. has 0 FDA recalls, 0 inspections, 15 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Smith And Nephew Donjoy, Inc." and its spelling variant "Smith And Nephew Donjoy".

Latest 510(k)
Jul 10, 1997

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances15Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent 510(k) clearances

15 510(k) clearances from Jan 16, 1991 to Jul 10, 1997.

K-NumberDeviceDate
K970051MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICEJul 10, 1997
K963489WHEEL CHAIR ACCESSORYNov 12, 1996
K963492PROTECTIVE RESTRAINTNov 12, 1996
K963490PROTECTIVE RESTRAINT - BELTSNov 12, 1996
K962462MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATORSep 23, 1996
K955057MODEL 1100 COLD THERAPY DEVICEMar 8, 1996
K951350MUSCLESENSE ELECTROMYOGRAPHY DEVICEJun 23, 1995
K945687ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREWJun 22, 1995
K946313TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZERMar 17, 1995
K945236AIMS CANNULATED ACL SCREW (7MM DIAMETER)Feb 3, 1995
K932592BRACE NEUTRALIZERMar 18, 1994
K932862ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREWMar 10, 1994
K934044ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEMMar 10, 1994
K932320NEUTRALIZEROct 6, 1993
K903823SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPEJan 16, 1991

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FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.