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."
169–192 of 549
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Aug 23, 2012
POLARCUP DUAL MOBILITY SYSTEM
K122244 · LPH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 13, 2012
JOURNEY II CR KNEE SYSTEM
K121443 · JWH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Aug 07, 2012
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
K121393 · MBH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jul 19, 2012
SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
K120211 · LZO
Smith & Nephew, Inc.
Orthopedic · 177d
Cleared Jun 22, 2012
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
K121018 · MBI
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Jun 07, 2012
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871 · JDW
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared May 18, 2012
GENESIS II PS NON-MODULAR FEMORAL COMPONENT
K120698 · JWH
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared May 16, 2012
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K112127 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 296d
Cleared Apr 27, 2012
R3 XLPE LINERS
K113848 · MBL
Smith & Nephew, Inc.
Orthopedic · 120d
Cleared Apr 19, 2012
MODULAR PROXIMALLY FLUTED HIP STEM
K113789 · MEH
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Apr 04, 2012
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR...
K120667 · HRS
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 06, 2012
FOOTPRINT ULTRA PK SUTURE ANCHOR
K113274 · MBI
Smith & Nephew, Inc.
Orthopedic · 120d
Cleared Feb 27, 2012
JOURNEY II DEEP DISHED ARTICULAR INSERTS
K113482 · JWH
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Jan 31, 2012
TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
K112526 · MBI
Smith & Nephew, Inc.
Orthopedic · 153d
Cleared Jan 20, 2012
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
K113294 · MBI
Smith & Nephew, Inc.
Orthopedic · 73d
Cleared Jan 05, 2012
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM...
K113038 · HSX
Smith & Nephew, Inc.
Orthopedic · 85d
Cleared Jan 05, 2012
PROMOS MODULAR SHOULDER SYSTEM
K113012 · KWS
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Dec 20, 2011
LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL...
K112941 · JWH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Dec 15, 2011
PICO
K111170 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 233d
Cleared Nov 22, 2011
RENASYS AB ABOMINAL DRESSING KIT
K112784 · FTL
Smith & Nephew, Inc.
General & Plastic Surgery · 57d
Cleared Nov 22, 2011
TRUCLEAR OPERATIVE HYSTEROSCOPE
K112134 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 118d
Cleared Nov 14, 2011
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
K112406 · HRS
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Oct 14, 2011
POLARCUP DUAL MOBILITY SYSTEM
K110135 · LPH
Smith & Nephew, Inc.
Orthopedic · 269d
Cleared Oct 11, 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994 · HWC
Smith & Nephew, Inc.
Orthopedic · 90d