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"
361–384 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Apr 01, 2010
SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR
K093844 · MAI
Smith & Nephew, Inc.
Orthopedic · 107d
Cleared Mar 05, 2010
BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM
K093943 · MBI
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 73d
Cleared Mar 04, 2010
SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR
K093897 · MBI
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 76d
Cleared Mar 01, 2010
PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
K093414 · LJT
Smiths Medical Asd, Inc.
General Hospital · 119d
Cleared Feb 23, 2010
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
K100107 · OLO
Smith & Nephew, Inc.
Orthopedic · 40d
Cleared Feb 19, 2010
SONALIS
K100204 · ITX
Smith Associates
Radiology · 25d
Cleared Feb 19, 2010
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS
K100197 · HSX
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jan 28, 2010
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST...
K092508 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 164d
Cleared Jan 26, 2010
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
K093363 · MBL
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jan 22, 2010
PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS
K092098 · LPH
Smith & Nephew, Inc.
Orthopedic · 192d
Cleared Dec 21, 2009
LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS
K091543 · MBH
Smith & Nephew, Inc.
Orthopedic · 209d
Cleared Dec 17, 2009
SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
K093428 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 44d
Cleared Dec 15, 2009
SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR
K093228 · MBI
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Dec 15, 2009
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
K093056 · NPJ
Smith & Nephew, Inc.
Orthopedic · 76d
Cleared Dec 10, 2009
AFGHAN EXTERNAL FIXATOR
K092002 · KTT
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Nov 04, 2009
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
K092657 · CAZ
Smiths Medical Asd, Inc.
Anesthesiology · 68d
Cleared Nov 03, 2009
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
K092386 · MBL
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Sep 29, 2009
JOURNEY BCS KNEE SYSTEM
K091014 · JWH
Smith & Nephew, Inc.
Orthopedic · 173d
Cleared Sep 11, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
K092497 · OLO
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Aug 18, 2009
PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT
K083031 · BTO
Smiths Medical Asd, Inc.
Anesthesiology · 312d
Cleared Jul 30, 2009
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K092015 · HRS
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Jul 22, 2009
ACTICOAT FLEX 7 DRESSING
K083113 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 274d
Cleared Jul 16, 2009
SMITH & NEPHEW RF CANNULATE
K090955 · GXI
Smith & Nephew, Inc.
Neurology · 101d
Cleared Jul 09, 2009
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
K091470 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 52d