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"
481–504 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Feb 07, 2008
CIMPLICITY SPINAL SYSTEM
K073320 · ODP
Spine Smith Partners L.P.
Orthopedic · 73d
Cleared Jan 10, 2008
SMITH & NEPHEW MIS HIP STEM
K072417 · LPH
Smith & Nephew, Inc.
Orthopedic · 135d
Cleared Dec 20, 2007
LEGION POROUS PRIMARY
K073325 · MBH
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Dec 20, 2007
JOURNEY UNICONDYLAR FEMORAL IMPLANT
K073175 · HSX
Smith & Nephew, Inc.
Orthopedic · 37d
Cleared Dec 14, 2007
POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE...
K072657 · LJT
Smiths Medical MD, Inc.
General Hospital · 85d
Cleared Dec 13, 2007
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
K072594 · FGA
Gyrus Acmi, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 10, 2007
TWINFIX FT PK
K072785 · HWC
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 70d
Cleared Dec 06, 2007
LEGION STEM WITH HOLES
K072531 · JWH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Nov 30, 2007
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200,...
K072783 · JKA
Smiths Medical Asd, Inc.
Chemistry · 60d
Cleared Nov 29, 2007
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · MEG
Smiths Medical Asd, Inc.
General Hospital · 86d
Cleared Nov 21, 2007
THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE...
K071958 · BTT
Smiths Medical Asd, Inc.
Anesthesiology · 128d
Cleared Nov 20, 2007
TC-PLUS PRIMARY KNEE SYSTEM
K072858 · JWH
Smith & Nephew, Inc.
Orthopedic · 46d
Cleared Nov 19, 2007
PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS
K072818 · HRS
Smith & Nephew, Inc.
Orthopedic · 48d
Cleared Nov 09, 2007
ADVANTIV SAFETY I.V. CATHETER
K072419 · FOZ
Smiths Medical Asd, Inc.
General Hospital · 73d
Cleared Nov 09, 2007
POLYGRAFT BGS
K062607 · MQV
Smith & Nephew, Inc.
Orthopedic · 430d
Cleared Nov 01, 2007
GRIPPER MICRO NEEDLE
K072059 · FMI
Smiths Medical MD, Inc.
General Hospital · 98d
Cleared Oct 15, 2007
SMITH & NEPHEW ARTHROSCOPE
K072675 · HRX
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Oct 05, 2007
REFLECTION, TANDEM UNIPOLAR
K071160 · LPH
Smith & Nephew, Inc.
General & Plastic Surgery · 162d
Cleared Oct 04, 2007
PNEUPAC VR1 AIR MIX
K071527 · BTL
Smiths Medical International , Ltd.
Anesthesiology · 122d
Cleared Sep 19, 2007
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
K071071 · JWH
Smith & Nephew, Inc.
Orthopedic · 156d
Cleared Sep 18, 2007
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
K072322 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 29d
Cleared Aug 17, 2007
GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE...
K071790 · MBH
Smith & Nephew, Inc.
Orthopedic · 46d
Cleared Aug 17, 2007
BIORAPTOR 2.3 PK SUTURE ANCHOR
K071586 · MBI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 67d
Cleared Aug 08, 2007
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K071563 · HRS
Smith & Nephew, Inc.
Orthopedic · 62d