Company ยท US
Johnson & Johnson International
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1997. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 |
| FRO | Dressing, Wound, Drug | 1 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 |
| KGX | Tape And Bandage, Adhesive | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| KMF | Bandage, Liquid | 1 |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | 1 |
| OVZ | Pin, Fixation, Resorbable, Hard Tissue | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 1997 | K965198 | ULTIMA TPS CEMENTED STEM Johnson & Johnson International | KWL |
| May 19, 1995 | K944937 | SYNTHETIC ABSORBABLE SUTURE Johnson & Johnson International | GAM |
| Apr 11, 1995 | K946245 | TIELLE* HYDROPOLYMER DRESSING Johnson & Johnson International | KMF |
| Aug 22, 1994 | K942383 | DERMIVIEW CLEAR TAPE Johnson & Johnson International | KGX |
| Jul 6, 1993 | K922918 | BARRIER SAF-TE HYDROGEL DRAPE Johnson & Johnson International | KKX |
| Nov 9, 1992 | K923807 | P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS Johnson & Johnson International | JWH |
| Nov 21, 1990 | K896828 | BIOCLUSIVE(R) ABSORBENT DRESSING Johnson & Johnson International | KOZ |
| Aug 15, 1990 | K901456 | ORTHOSORB(R) ABSORBABLE PIN Johnson & Johnson International | OVZ |
| Apr 30, 1990 | K900638 | P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT Johnson & Johnson International | KWL |
| Sep 28, 1989 | K895207 | BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM Johnson & Johnson International | FRO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||