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"
721–744 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Oct 29, 1997
MSI PRESSURE INFUSOR
K973843 · KZD
Smith Assoc.
General Hospital · 21d
Cleared Oct 24, 1997
DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND...
K972471 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 115d
Cleared Sep 19, 1997
ACUFEX SCREW CANNULA
K972599 · HWC
Smith & Nephew Endoscopy, Inc.
Orthopedic · 67d
Cleared Aug 14, 1997
TITANIUM SPINAL ROD SYSTEM
K970635 · KWQ
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 175d
Cleared Aug 12, 1997
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES
K971850 · GCJ
Smith & Nephew, Inc.
General & Plastic Surgery · 84d
Cleared Aug 12, 1997
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
K970511 · HRX
Smith & Nephew, Inc.
Orthopedic · 182d
Cleared Aug 06, 1997
SMITH & NEPHEW SUTURE COLLET
K971939 · OCW
Smith & Nephew Endoscopy, Inc.
Gastroenterology & Urology · 71d
Cleared Jul 25, 1997
PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905
K972123 · FMQ
Smith
General Hospital · 50d
Cleared Jul 16, 1997
ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS
K971414 · LZO
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 91d
Cleared Jul 10, 1997
MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
K970051 · HCC
Smith and Nephew Donjoy, Inc.
Neurology · 184d
Cleared Jul 03, 1997
NOVIGUARD QUICK DRY
K961044 · LRJ
Dr. Novis Smith & Co., Inc.
General Hospital · 476d
Cleared Jun 27, 1997
LIMITED REUSE ENDOSCOPIC BLADES
K971676 · HRX
Smith & Nephew, Inc.
Orthopedic · 51d
Cleared Jun 27, 1997
SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE...
K971188 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 88d
Cleared Jun 13, 1997
VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
K971253 · HRX
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared May 20, 1997
SCOPETEX(TM)
K945590 · CCW
Smith Helms Mulliss & Moore, L.L.P.
Anesthesiology · 918d
Cleared May 09, 1997
TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM
K970748 · KTT
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 67d
Cleared May 08, 1997
EMPOWER ANTERIOR DIRECT SCREWS
K965224 · KWP
Smith & Nephew Richards, Inc.
Orthopedic · 129d
Cleared Apr 23, 1997
QA-ES
K971092 · GEI
Smith
General & Plastic Surgery · 28d
Cleared Apr 23, 1997
SMITH & NEPHEW MIS INSTRUMENTS
K970949 · GCJ
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 40d
Cleared Apr 21, 1997
ACUFEX DOUBLE ARMED SUTURE NEEDLE
K970416 · GAT
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 76d
Cleared Apr 16, 1997
HEIDELBERG EXTERNAL FIXATOR
K970751 · JDW
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 44d
Cleared Apr 15, 1997
MODEL 1100 COLD THERAPY DEVICE
K970533 · ILO
Smith & Nephew, Inc.
Physical Medicine · 62d
Cleared Apr 03, 1997
COMPASS UNIVERSAL HINGE
K970713 · JDW
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 35d
Cleared Mar 21, 1997
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K970247 · EOB
Smith & Nephew, Inc.
Ear, Nose, Throat · 58d