Johnson & Johnson International
Urb Santa Paula, PR, US
Johnson & Johnson International appears in FDA device records in Urb Santa Paula, PR. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Johnson & Johnson International between 1989 and 1997. The busiest year on record is 1990, with 3. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1990 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K965198 | ULTIMA TPS CEMENTED STEM | KWL | Substantially Equivalent | |
| K944937 | SYNTHETIC ABSORBABLE SUTURE | GAM | Substantially Equivalent | |
| K946245 | TIELLE* HYDROPOLYMER DRESSING | KMF | Substantially Equivalent | |
| K942383 | DERMIVIEW CLEAR TAPE | KGX | Substantially Equivalent | |
| K922918 | BARRIER SAF-TE HYDROGEL DRAPE | KKX | Substantially Equivalent | |
| K923807 | P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS | JWH | Substantially Equivalent | |
| K896828 | BIOCLUSIVE(R) ABSORBENT DRESSING | KOZ | Substantially Equivalent | |
| K901456 | ORTHOSORB(R) ABSORBABLE PIN | OVZ | Substantially Equivalent | |
| K900638 | P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT | KWL | Substantially Equivalent | |
| K895207 | BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM | FRO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005273611 | 3005273611 | Johnson & Johnson International | Calle C No. 475, Urb Santa Paula, PR 00969 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KMFBandage, Liquid
- KOZBeads, Hydrophilic, For Wound Exudate Absorption
- KKXDrape, Surgical, Antimicrobial
- FRODressing, Wound, Drug
- OVZPin, Fixation, Resorbable, Hard Tissue
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- KGXTape And Bandage, Adhesive
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