Pedicraft, Inc.
Jacksonville, FL, US
PEDICRAFT, INC. appears in FDA device records in Jacksonville, FL. FDA records list 5 510(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 5 510(k) clearances for Pedicraft, Inc. between 1982 and 1993. The busiest year on record is 1991, with 2. The most recent is 1993, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1991 | 2 |
| 1993 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K925949 | PEDICRAGT BASSINET | FMS | Substantially Equivalent | |
| K925817 | HEAD & FOOT END DROP PEDI-CRIB | FMS | Substantially Equivalent | |
| K905630 | INFANT REFLUX SLING | FRP | Substantially Equivalent | |
| K905629 | PEDICRAFT INFANT REFLUX WEDGE | FRP | Substantially Equivalent | |
| K821773 | PEDICRAFT BED, MODEL B2944 | FMS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1043568 | 1043568 | PEDICRAFT, INC. | 4134 ST. AUGUSTINE RD., JACKSONVILLE, FL 32247 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
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