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"
241–264 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Oct 28, 2015
JOURNEY II Uni Tibial Base and Insert
K152315 · HSX
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Oct 27, 2015
Genesis II XLPE Resurfacing Patellar Components
K150241 · JWH
Smith & Nephew, Inc.
Orthopedic · 267d
Cleared Oct 23, 2015
R-40 EEG Amplifier
K151600 · GWL
Lifelines , Ltd.
Neurology · 133d
Cleared Oct 21, 2015
JOURNEY II XR Knee System
K152726 · JWH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Oct 07, 2015
Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam...
K151261 · OMP
Medela AG
General & Plastic Surgery · 148d
Cleared Sep 03, 2015
REDAPT¿ Revision Femoral System
K151902 · LZO
Smith & Nephew, Inc.
Orthopedic · 55d
Cleared Sep 02, 2015
TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
K152143 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 30d
Cleared Aug 21, 2015
Lifelines iEEG
K143487 · OLT
Kvikna Ehf
Neurology · 256d
Cleared Jul 28, 2015
Smith and Nephew Legion Hinge Knee System
K151118 · KRO
Smith & Nephew
Orthopedic · 92d
Cleared Jul 28, 2015
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and...
K151105 · MAI
Smith & Nephew, Inc.
Orthopedic · 95d
Cleared Jul 23, 2015
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal...
K143133 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 265d
Cleared Jul 16, 2015
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
K151326 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 59d
Cleared Jul 15, 2015
The VersaJet II Hydrosurgery System
K143115 · FQH
Smith & Nephew, Inc.
General Hospital · 258d
Cleared Jun 17, 2015
STAR 90
K150512 · MWI
Skanray Technologies Pvt, Ltd.
Cardiovascular · 110d
Cleared Apr 29, 2015
RENASYS
K142979 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 196d
Cleared Apr 20, 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
K143739 · LZO
Smith & Nephew, Inc.
Orthopedic · 111d
Cleared Mar 24, 2015
SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
K143096 · LZO
Smith & Nephew, Inc.
Orthopedic · 147d
Cleared Feb 18, 2015
Polysmith Sleep System
K142774 · OLV
Neurotronics, Inc.
Neurology · 145d
Cleared Feb 12, 2015
Visionaire Disposable Instruments
K143226 · JWH
Smith & Nephew, Inc.
Orthopedic · 94d
Cleared Feb 04, 2015
ACL SMART System
K143172 · MAI
Smith & Nephew, Inc.
Orthopedic · 92d
Cleared Jan 13, 2015
BIOSURE REGENESORB interference Screw
K142948 · MAI
Smith & Nephew, Inc.
Orthopedic · 95d
Cleared Dec 22, 2014
ANTHEM PS Total Knee System
K142807 · JWH
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Dec 18, 2014
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050 · HRS
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Nov 25, 2014
IN:C2 SPINAL FIXATION SYSTME
K141537 · OVE
Spine Smith Holdings, LLC
Orthopedic · 168d