Smith and Nephew Donjoy, Inc.
Carsbad, CA, US
Smith and Nephew Donjoy, Inc. appears in FDA device records in Carsbad, CA. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Smith and Nephew Donjoy, Inc. between 1991 and 1997. The busiest year on record is 1996, with 5. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 4 |
| 1996 | 5 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K970051 | MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE | HCC | Substantially Equivalent | |
| K963492 | PROTECTIVE RESTRAINT | FMQ | Substantially Equivalent | |
| K963490 | PROTECTIVE RESTRAINT - BELTS | FMQ | Substantially Equivalent | |
| K963489 | WHEEL CHAIR ACCESSORY | FMQ | Substantially Equivalent | |
| K962462 | MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR | IPF | Substantially Equivalent | |
| K955057 | MODEL 1100 COLD THERAPY DEVICE | ILO | Substantially Equivalent for Some Indications | |
| K951350 | MUSCLESENSE ELECTROMYOGRAPHY DEVICE | HCC | Substantially Equivalent | |
| K945687 | ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW | HWC | Substantially Equivalent for Some Indications | |
| K946313 | TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER | HRX | Substantially Equivalent | |
| K945236 | AIMS CANNULATED ACL SCREW (7MM DIAMETER) | HWC | Substantially Equivalent | |
| K932592 | BRACE NEUTRALIZER | GZJ | Substantially Equivalent | |
| K934044 | ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM | HWC | Substantially Equivalent | |
| K932862 | ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW | HWC | Substantially Equivalent for Some Indications | |
| K932320 | NEUTRALIZER | GZJ | Substantially Equivalent | |
| K903823 | SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE | KGX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain