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"
481–504 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jun 06, 2007
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
K070756 · MBL
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared May 23, 2007
POWER PORT-A-CATH AND POWER PORT-A-CATH II
K070116 · LJT
Smiths Medical MD, Inc.
General Hospital · 131d
Cleared May 18, 2007
COFIELD TOTAL SHOULDER SYSTEM
K070565 · MBF
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared May 16, 2007
SMITH & NEPHEW KINSA RC SUTURE ANCHOR
K070908 · MBI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 44d
Cleared May 09, 2007
POLYSMITH SLEEP SYSTEM, MODEL NTI5498
K062943 · OLZ
Neurotronics, Inc.
Neurology · 223d
Cleared Apr 12, 2007
ENDOBUTTON DIRECT
K070167 · MBI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 84d
Cleared Mar 15, 2007
SECURE ARTERIAL BLOOD SAMPLING SYSTEM
K070340 · CBT
Smiths Medical Asd, Inc.
Anesthesiology · 37d
Cleared Mar 06, 2007
PLC SUTURE ANCHOR
K063726 · HRS
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 81d
Cleared Feb 27, 2007
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
K063755 · MEG
Smiths Medical Asd, Inc.
General Hospital · 70d
Cleared Feb 26, 2007
CAPTION APPLICATOR
K063535 · FMF
Smith & Nephew, Inc.
General Hospital · 96d
Cleared Feb 22, 2007
560 HIGH DEFINITION CAMERA SYSTEM
K070266 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 24d
Cleared Jan 25, 2007
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1,...
K063450 · FMI
Smiths Medical Asd, Inc.
General Hospital · 71d
Cleared Jan 19, 2007
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
K062849 · HRX
Smith & Nephew, Inc.
Orthopedic · 116d
Cleared Dec 22, 2006
SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV...
K060851 · LGZ
The Smithworks Company
General Hospital · 269d
Cleared Dec 07, 2006
MODIFICATION TO: SMITHWICK CAROTID SHUNT
K061484 · DXC
Mcpherson Enterprises, Inc.
Cardiovascular · 191d
Cleared Nov 29, 2006
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE
K062592 · FRN
Smiths Medical MD, Inc.
General Hospital · 89d
Cleared Nov 21, 2006
SMITH & NEPHEW RF CANNULAE
K063467 · GXI
Smith & Nephew, Inc.
Neurology · 28d
Cleared Nov 09, 2006
SMITHWICK CAROTID SHUNT
K062474 · DXC
Mcpherson Enterprises, Inc.
Cardiovascular · 77d
Cleared Nov 01, 2006
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER,...
K062323 · LZG
Smiths Medical MD, Inc.
General Hospital · 84d
Cleared Oct 18, 2006
PORTEX EPIDURAL CATHETER
K062005 · BSO
Smiths Medical Asd, Inc.
Anesthesiology · 93d
Cleared Sep 15, 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K062216 · HRS
Smith & Nephew, Inc.
Orthopedic · 45d
Cleared Sep 12, 2006
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
K062408 · KWL
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Aug 24, 2006
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510,...
K061194 · MEG
Smiths Medical Asd, Inc.
General Hospital · 118d
Cleared Aug 10, 2006
KNEE FUSION NAIL
K061783 · JDS
Smith & Nephew, Inc.
Orthopedic · 45d