Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

549 results for "Smith & Nephew, Inc."
217–240 of 549
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Aug 06, 2010
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
K102001 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 22d
Cleared Jul 15, 2010
SMITH & NEPHEW MDF MODULAR SLEEVE
K100481 · MEH
Smith & Nephew, Inc.
Orthopedic · 147d
Cleared May 13, 2010
LEGION POROUS + HA TIBIAL BASEPLATES
K100897 · MBH
Smith & Nephew, Inc.
Orthopedic · 43d
Cleared May 05, 2010
BIOLOX DELTA CERAMIC FEMORAL HEADS
K100412 · LZO
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared May 04, 2010
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
K100325 · HWC
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Apr 26, 2010
SURESHOT TAN NAILS AND ACCESSORIES
K092748 · HSB
Smith & Nephew, Inc.
Orthopedic · 230d
Cleared Apr 21, 2010
SMITH & NEPHEW HIP SYSTEMS WITH HA
K090982 · MEH
Smith & Nephew, Inc.
Orthopedic · 379d
Cleared Apr 15, 2010
SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS
K093991 · LZO
Smith & Nephew, Inc.
Orthopedic · 112d
Cleared Apr 14, 2010
VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM
K093746 · JWH
Smith & Nephew, Inc.
Orthopedic · 131d
Cleared Apr 05, 2010
SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR
K093935 · MBI
Smith & Nephew, Inc.
Orthopedic · 104d
Cleared Apr 01, 2010
SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR
K093844 · MAI
Smith & Nephew, Inc.
Orthopedic · 107d
Cleared Feb 23, 2010
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
K100107 · OLO
Smith & Nephew, Inc.
Orthopedic · 40d
Cleared Feb 19, 2010
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS
K100197 · HSX
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jan 28, 2010
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST...
K092508 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 164d
Cleared Jan 26, 2010
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
K093363 · MBL
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jan 22, 2010
PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS
K092098 · LPH
Smith & Nephew, Inc.
Orthopedic · 192d
Cleared Dec 21, 2009
LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS
K091543 · MBH
Smith & Nephew, Inc.
Orthopedic · 209d
Cleared Dec 15, 2009
SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR
K093228 · MBI
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Dec 15, 2009
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
K093056 · NPJ
Smith & Nephew, Inc.
Orthopedic · 76d
Cleared Dec 10, 2009
AFGHAN EXTERNAL FIXATOR
K092002 · KTT
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Nov 03, 2009
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
K092386 · MBL
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Sep 29, 2009
JOURNEY BCS KNEE SYSTEM
K091014 · JWH
Smith & Nephew, Inc.
Orthopedic · 173d
Cleared Sep 11, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
K092497 · OLO
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jul 30, 2009
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K092015 · HRS
Smith & Nephew, Inc.
Orthopedic · 24d