• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
1 1

FDA 510(k) K042515, SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE, by Smith & Nephew, Inc.

FDA 510(k) K042515, SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE, by Smith & Nephew, Inc.

$89.00 USD
$89.00 USD
Sale Sold out
510(K) Number: K042515
Device Name: SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
Manufacturer: Smith & Nephew, Inc.
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 09/16/2004
Decision Date: 03/14/2005
Regulation Medical Specialty: Orthopedic
View full details
FOIA Pro

This drug has a lot more FDA history than one product page can show

FOIA Pro gives you full-text search across 70,000+ FDA FOIA records, from 2020 through today, plus a monthly monitor tracking new requests as they close.
  • Full-text search across every FDA FOIA log since 2020
  • Warning letters, approval records, and correspondence in one place
  • Monthly FDA FOIA Monitor newsletter, included
  • Cancel anytime, monthly or annual billing
Get FOIA Pro
Live search · FOIA database
Searching related FDA records…
ClosedTypeSubjectOutcome