FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,107 results for "smith"
169–192 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Nov 21, 2017
Smith & Nephew, Inc. REDAPT Augments
K171073 · LPH
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Nov 16, 2017
JOURNEY II XR Knee Instruments
K173331 · JWH
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Nov 09, 2017
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit,...
K172458 · DRS
Smiths Medical Asd, Inc.
Cardiovascular · 87d
Cleared Oct 13, 2017
NOVOS-NAIL Limb Lengthening System (LLS)
K163653 · HSB
Smith & Nephew
Orthopedic · 294d
Cleared Oct 03, 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
K172684 · LPH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Sep 20, 2017
PICO Single Use Negative Pressure Wound Therapy System
K172521 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 30d
Cleared Sep 15, 2017
PICO Single Use Negative Pressure Wound Therapy System
K172519 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 25d
Cleared Aug 24, 2017
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication
K170982 · MEA
Smiths Medical Ads, Inc.
General Hospital · 143d
Cleared Aug 23, 2017
EVOS Small Fragment Plating System
K172262 · HRS
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Jul 20, 2017
CADD® Infusion Disposables Portfolio with NRFit™ connectors
K162219 · PWH
Smiths Medical Asd, Inc.
General Hospital · 346d
Cleared Jun 27, 2017
Smith & Nephew 25 Fluid Management System
K171794 · HRX
Smith & Nephew, Inc.
Orthopedic · 11d
Cleared Jun 23, 2017
Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics
K171324 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 49d
Cleared Jun 19, 2017
Smith & Nephew, Inc. R3™ Constrained Liner
K162641 · KWZ
Smith & Nephew, Inc.
Orthopedic · 270d
Cleared Jun 14, 2017
EVOS Small Fragment Lower Extremity Plates
K170457 · HRS
Smith & Nephew, Inc.
Orthopedic · 119d
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 Jan 19, 2017
Polysmith Sleep System, Model NTI7593
K161650 · OLV
Neurotronics, Inc.
Neurology · 218d