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"
289–312 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared May 14, 2013
ILIZAROV DRILL TIP WIRES
K130479 · KTT
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared May 03, 2013
SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
K123159 · JWH
Smith & Nephew, Inc.
Orthopedic · 206d
Cleared Apr 11, 2013
HEALICOIL SUTURE ANCHOR WITH REGENESORB
K123393 · MAI
Smith & Nephew, Inc.
Orthopedic · 160d
Cleared Mar 18, 2013
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR...
K122059 · MBI
Smith & Nephew, Inc.
Orthopedic · 248d
Cleared Mar 14, 2013
CHINA NAILS AND ACCESSORIES
K123948 · JDS
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Mar 11, 2013
GYNECOLOGY STERILIZATION TRAY
K121904 · KCT
Smith & Nephew Inc., Endoscopy Division
General Hospital · 255d
Cleared Feb 20, 2013
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
K123425 · MBI
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Feb 01, 2013
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY...
K111275 · FRN
Smiths Medical Asd, Inc.
General Hospital · 637d
Cleared Jan 25, 2013
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
K123055 · HRS
Smith & Nephew, Inc.
Orthopedic · 116d
Cleared Jan 23, 2013
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
K123579 · MBI
Smith & Nephew, Inc.
Orthopedic · 65d
Cleared Jan 04, 2013
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING...
K123731 · LFD
Glaxosmithkline Consumer Healthcare...
Dental · 30d
Cleared Dec 05, 2012
IN:C2 SPINAL FIXATION SYSTEM
K122630 · OVE
Spine Smith Partners L.P.
Orthopedic · 99d
Cleared Nov 20, 2012
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · HWC
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Oct 24, 2012
SMITH & NEPHEW SMF HIP STEM
K123012 · LPH
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Oct 19, 2012
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
K122170 · HSB
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Oct 18, 2012
SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA...
K121861 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 114d
Cleared Oct 16, 2012
SMITH & NEPHEW R3 CONSTRAINED LINERS
K122139 · KWZ
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Oct 15, 2012
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
K121627 · MEH
Smith & Nephew, Inc.
Orthopedic · 133d
Cleared Oct 11, 2012
VISUALIF CHALLENGING ACCESS PLATE
K122168 · OVD
Spine Smith Partners L.P.
Orthopedic · 80d
Cleared Oct 05, 2012
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
K113039 · MEH
Smith & Nephew, Inc.
Orthopedic · 359d
Cleared Sep 14, 2012
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR,...
K110053 · CAZ
Smiths Medical Asd, Inc.
Anesthesiology · 616d
Cleared Sep 07, 2012
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714 · HSD
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Aug 28, 2012
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
K122296 · LZO
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Aug 23, 2012
POLARCUP DUAL MOBILITY SYSTEM
K122244 · LPH
Smith & Nephew, Inc.
Orthopedic · 27d