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"
193–216 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jun 14, 2017
EVOS Small Fragment Lower Extremity Plates
K170457 · HRS
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Jun 13, 2017
Deep Conical (DC) Implants and Accessories
K163060 · DZE
Southern Implants (Pty), Ltd.
Dental · 224d
Cleared Jun 08, 2017
INVISIKNOT Ankle Syndesmosis Repair Kit
K162996 · HTN
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared May 24, 2017
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit,...
K163172 · DRS
Smiths Medical Asd, Inc.
Cardiovascular · 191d
Cleared May 22, 2017
Smith & Nephew VISIONAIRE Adaptive Guides
K170282 · JWH
Smith & Nephew, Inc.
Orthopedic · 112d
Cleared May 11, 2017
ANTHEM CR Total Knee System
K170648 · JWH
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared May 03, 2017
SURESHOT Distal Targeting System V4.0 Trauma Interface
K170977 · OLO
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared May 01, 2017
REDAPT Sleeved Monolithic Revision Stems
K162303 · MEH
Smith & Nephew, Inc.
Orthopedic · 257d
Cleared Apr 28, 2017
Smith & Nephew SURESHOT Distal Targeting System V4.0
K170280 · OLO
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Apr 24, 2017
EVOS Small Fragment Plating System
K170887 · HRS
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Apr 18, 2017
PICO Single Use Negative Pressure Wound Therapy System
K163387 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 137d
Cleared Mar 02, 2017
RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
K161737 · NEW
Myco Medical
General & Plastic Surgery · 252d
Cleared Jan 19, 2017
Polysmith Sleep System, Model NTI7593
K161650 · OLV
Neurotronics, Inc.
Neurology · 218d
Cleared Jan 13, 2017
Legion Cone System
K162775 · JWH
Smith & Nephew, Inc.
Orthopedic · 102d
Cleared Jan 13, 2017
Kolplast Cervical Sample Collection Kit
K153128 · HHT
Kolplast CI SA
Pathology · 442d
Cleared Dec 21, 2016
VLP MINI-MOD 2.0mm Column Plates
K163086 · HRS
Smith & Nephew, Inc.
Orthopedic · 48d
Cleared Dec 14, 2016
OXINIUM DH Fermoral Heads
K161233 · MBL
Smith & Nephew, Inc.
Orthopedic · 226d
Cleared Dec 07, 2016
SUTUREFIX Curved Suture Anchor
K163034 · MBI
Smith and Nephew, Inc.
Orthopedic · 37d
Cleared Dec 01, 2016
Osseointegrated Fixtures
K161548 · FZE
Southern Implants (Pty), Ltd.
General & Plastic Surgery · 181d
Cleared Nov 23, 2016
TRIGEN Low Profile Bone Screws
K161264 · HSB
Smith & Nephew, Inc.
Orthopedic · 202d
Cleared Nov 22, 2016
Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
K161763 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 148d
Cleared Nov 18, 2016
EVOS Small Fragment Plating System
K162078 · HRS
Smith & Nephew, Inc.
Orthopedic · 114d
Cleared Nov 17, 2016
REDAPT Anteverted Cemented Liner
K160923 · JDI
Smith & Nephew, Inc.
Orthopedic · 227d
Cleared Nov 15, 2016
VLP Wrist Fracture System
K161665 · HRS
Smith & Nephew, Inc.
Orthopedic · 152d