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."
265–288 of 549
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Aug 21, 2008
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
K081566 · LPH
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Jul 31, 2008
MDF REVISION HIP SYSTEM
K081124 · MEH
Smith & Nephew, Inc.
Orthopedic · 101d
Cleared Jul 24, 2008
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
K081351 · HSX
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jul 23, 2008
LEGION HINGE KNEE SYSTEM
K081111 · KRO
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Jul 18, 2008
PIGALILEO 4TH GENERATION SYSTEM
K080875 · HAW
Smith & Nephew, Inc.
Neurology · 109d
Cleared Jun 19, 2008
SMITH & NEPHEW CDS SYSTEM
K081491 · JAA
Smith & Nephew, Inc.
Radiology · 22d
Cleared Jun 18, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING...
K081106 · HRS
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Jun 09, 2008
SL-PLUS STANDARD AND LATERAL HIP STEMS
K072852 · LZO
Smith & Nephew, Inc.
Orthopedic · 249d
Cleared May 15, 2008
ECHELON TITANIUM HIP SYSTEM
K072817 · LPH
Smith & Nephew, Inc.
Orthopedic · 226d
Cleared May 08, 2008
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
K080625 · LPH
Smith & Nephew, Inc.
Orthopedic · 64d
Cleared Apr 10, 2008
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW
K080434 · JDO
Smith & Nephew, Inc.
Orthopedic · 51d
Cleared Mar 07, 2008
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
K072212 · KTT
Smith & Nephew, Inc.
Orthopedic · 211d
Cleared Mar 04, 2008
TWINFIX PK FP SUTURE ANCHOR
K073509 · HWC
Smith & Nephew, Inc.
Orthopedic · 82d
Cleared Feb 22, 2008
SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM
K073466 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 74d
Cleared Jan 10, 2008
SMITH & NEPHEW MIS HIP STEM
K072417 · LPH
Smith & Nephew, Inc.
Orthopedic · 135d
Cleared Dec 20, 2007
LEGION POROUS PRIMARY
K073325 · MBH
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Dec 20, 2007
JOURNEY UNICONDYLAR FEMORAL IMPLANT
K073175 · HSX
Smith & Nephew, Inc.
Orthopedic · 37d
Cleared Dec 06, 2007
LEGION STEM WITH HOLES
K072531 · JWH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Nov 20, 2007
TC-PLUS PRIMARY KNEE SYSTEM
K072858 · JWH
Smith & Nephew, Inc.
Orthopedic · 46d
Cleared Nov 19, 2007
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS
K072818 · HRS
Smith & Nephew, Inc.
Orthopedic · 48d
Cleared Nov 09, 2007
POLYGRAFT BGS
K062607 · MQV
Smith & Nephew, Inc.
Orthopedic · 430d
Cleared Oct 15, 2007
SMITH & NEPHEW ARTHROSCOPE
K072675 · HRX
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Oct 05, 2007
REFLECTION, TANDEM UNIPOLAR
K071160 · LPH
Smith & Nephew, Inc.
General & Plastic Surgery · 162d
Cleared Sep 19, 2007
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
K071071 · JWH
Smith & Nephew, Inc.
Orthopedic · 156d