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"
529–552 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Oct 18, 2006
PORTEX EPIDURAL CATHETER
K062005 · BSO
Smiths Medical Asd, Inc.
Anesthesiology · 93d
Cleared Sep 15, 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K062216 · HRS
Smith & Nephew, Inc.
Orthopedic · 45d
Cleared Sep 12, 2006
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
K062408 · KWL
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Aug 24, 2006
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510,...
K061194 · MEG
Smiths Medical Asd, Inc.
General Hospital · 118d
Cleared Aug 10, 2006
KNEE FUSION NAIL
K061783 · JDS
Smith & Nephew, Inc.
Orthopedic · 45d
Cleared Aug 04, 2006
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
K061779 · HSX
Smith & Nephew, Inc.
Orthopedic · 39d
Cleared Aug 01, 2006
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET
K061513 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 61d
Cleared Jul 17, 2006
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243 · KWL
Smith & Nephew, Inc.
Orthopedic · 75d
Cleared Jul 14, 2006
SYNERGY HIP SYSTEM
K061066 · LZO
Smith & Nephew, Inc.
General & Plastic Surgery · 88d
Cleared Jul 12, 2006
PATIENT MATCHED HIP STEM
K053246 · LZO
Smith & Nephew, Inc.
Orthopedic · 233d
Cleared Jul 11, 2006
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
K061011 · HSX
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jul 06, 2006
SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS
K061569 · NPJ
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Jun 19, 2006
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
K060945 · BTO
Smiths Medical International
Anesthesiology · 74d
Cleared Jun 14, 2006
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
K060630 · LPH
Smith & Nephew, Inc.
Orthopedic · 97d
Cleared Jun 08, 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY
K061352 · HRS
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Jun 08, 2006
KINSA SUTURE ANCHOR
K061154 · MBI
Smith & Nephew, Inc.
Orthopedic · 43d
Cleared Jun 06, 2006
TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
K061019 · JDS
Smith & Nephew, Inc.
Orthopedic · 54d
Cleared May 31, 2006
REFLECTION 3 ACETABULAR SYSTEM
K061253 · MBL
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared May 17, 2006
PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE VENOUS...
K060036 · LJT
Smiths Medical MD, Inc.
General Hospital · 132d
Cleared May 03, 2006
LEGION COBALT CHROME REVISION KNEE SYSTEM
K060742 · JWH
Smith & Nephew, Inc.
Orthopedic · 44d
Cleared Apr 18, 2006
SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS
K060736 · HWC
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Apr 13, 2006
SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM
K060777 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 22d
Cleared Apr 12, 2006
VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE
K060782 · FQH
Smith & Nephew Wound Management
General Hospital · 21d
Cleared Feb 23, 2006
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE...
K053344 · HWC
Smith & Nephew, Inc.
Orthopedic · 83d