FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,136 results for "smith"
313–336 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
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 Aug 02, 2012
PERIFUSE CATHETER
K121525 · CAZ
Smiths Medical Asd, Inc.
Anesthesiology · 71d
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 14, 2012
VIAVALVE SAFETY IV CATHETER
K113700 · FOZ
Smiths Medical Asd, Inc.
General Hospital · 89d
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 Feb 09, 2012
SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
K112407 · DYB
Smiths Medical MD, Inc.
Cardiovascular · 171d
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