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"
553–576 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Feb 14, 2006
LEVELERT II FLUID LEVEL SENSOR
K060123 · FLN
Smith & Nephew, Inc.
General Hospital · 27d
Cleared Dec 27, 2005
SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL
K052265 · NPJ
Smith & Nephew, Inc.
Orthopedic · 130d
Cleared Dec 07, 2005
SMITH & NEPHEW MODULAR HIP
K052426 · MEH
Smith & Nephew, Inc.
Orthopedic · 96d
Cleared Dec 07, 2005
SMITH & NEPHEW PLATFORM HIP STEM
K052275 · LZO
Smith & Nephew, Inc.
Orthopedic · 107d
Cleared Nov 23, 2005
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
K050209 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 299d
Cleared Nov 17, 2005
CADD-MS 3 AMBULATORY INFUSION PUMP
K051568 · FRN
Smiths Medical MD, Inc.
General Hospital · 156d
Cleared Oct 21, 2005
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
K052652 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 25d
Cleared Oct 07, 2005
ANTHOLOGY HIP STEM
K052792 · JDI
Smith & Nephew, Inc.
Orthopedic · 4d
Cleared Aug 05, 2005
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
K051322 · BTL
Smiths Medical International , Ltd.
Anesthesiology · 77d
Cleared Jul 26, 2005
PLC SCREW
K051310 · HWC
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Jul 20, 2005
PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT
K051229 · JWH
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Jul 19, 2005
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY
K051735 · HRS
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jul 07, 2005
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
K051524 · BSO
Smiths Medical Asd, Inc.
Anesthesiology · 29d
Cleared Jul 01, 2005
SMITH & NEPHEW CDS SYSTEM
K051136 · JAA
Smith & Nephew, Inc.
Radiology · 58d
Cleared Jun 30, 2005
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS
K051557 · JDS
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared Jun 15, 2005
SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM
K051326 · HRX
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared May 31, 2005
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
K051086 · KRR
Smith & Nephew, Inc.
Orthopedic · 33d
Cleared May 26, 2005
PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
K050166 · BWC
Smiths Medical
Anesthesiology · 120d
Cleared May 25, 2005
SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX
K050898 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 44d
Cleared May 04, 2005
KNEE FUSION NAIL
K050938 · JDS
Smith & Nephew, Inc.
Orthopedic · 20d
Cleared May 04, 2005
HA COATED LAG SCREW
K050849 · KTT
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Apr 22, 2005
BABYPAC
K043495 · BTL
Smiths Medical International Ltd., Luton
Anesthesiology · 126d
Cleared Apr 21, 2005
ACTICOAT MOISTURE CONTROL DRESSING
K050030 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 104d
Cleared Apr 20, 2005
SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
K050580 · HRX
Smith & Nephew Endoscopy, Inc.
Orthopedic · 44d