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"
745–768 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Mar 19, 1997
DAKOTA SMITH, NICOLE MILLER SUNGLASSES
K965125 · HQY
California Design Studio, Inc.
Ophthalmic · 86d
Cleared Mar 18, 1997
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
K970151 · HET
Smith & Nephew, Inc.
Obstetrics & Gynecology · 62d
Cleared Mar 17, 1997
IL0292 DP ECHOPORT
K970555 · EWO
Smith
Ear, Nose, Throat · 32d
Cleared Mar 14, 1997
REGIONAL ANESTHESIA TRAYS
K965017 · CAZ
Smiths Industries Medical Systems, Inc.
Anesthesiology · 88d
Cleared Feb 28, 1997
GLOBAL TAPER SPECTRON HIP STEMS
K970351 · JDI
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 29d
Cleared Feb 28, 1997
HA GLOBAL TAPER (GT) TAPERED HIP STEM
K970337 · MEH
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 30d
Cleared Feb 27, 1997
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
K965073 · HWC
Smith & Nephew, Inc.
Orthopedic · 70d
Cleared Feb 25, 1997
SUTURE LOCK
K964935 · KGS
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 77d
Cleared Jan 27, 1997
GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
K963509 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 146d
Cleared Jan 24, 1997
FINN ROD TO ROD CONNECTOR
K960444 · KWP
Smith & Nephew Richards, Inc.
Orthopedic · 358d
Cleared Jan 17, 1997
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
K962175 · JOH
Smiths Industries Medical Systems, Inc.
Anesthesiology · 226d
Cleared Jan 02, 1997
PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL...
K963255 · JWH
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 136d
Cleared Dec 27, 1996
TRIMAX NAIL SYSTEM
K964163 · HSB
Smith & Nephew Richards, Inc.
Orthopedic · 71d
Cleared Dec 20, 1996
ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM
K964215 · HRX
Smith & Nephew Endoscopy, Inc.
Orthopedic · 59d
Cleared Dec 05, 1996
GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
K962557 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 157d
Cleared Nov 27, 1996
REVISION HIP SYSTEM
K963486 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 85d
Cleared Nov 12, 1996
PROTECTIVE RESTRAINT
K963492 · FMQ
Smith and Nephew Donjoy, Inc.
General Hospital · 70d
Cleared Nov 12, 1996
PROTECTIVE RESTRAINT - BELTS
K963490 · FMQ
Smith and Nephew Donjoy, Inc.
General Hospital · 70d
Cleared Nov 12, 1996
WHEEL CHAIR ACCESSORY
K963489 · FMQ
Smith and Nephew Donjoy, Inc.
General Hospital · 70d
Cleared Nov 06, 1996
FLEXSURE OBT
K961062 · KHE
Smithkline Diagnostics, Inc.
Hematology · 233d
Cleared Nov 04, 1996
ELECTROSURGICAL PROBE
K963901 · GEI
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 38d
Cleared Oct 25, 1996
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
K963096 · KMF
Smith & Nephew United, Inc.
General & Plastic Surgery · 77d
Cleared Oct 21, 1996
SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
K962931 · JKA
Smiths Industries Medical Systems, Inc.
Chemistry · 84d
Cleared Oct 18, 1996
SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
K963570 · FMJ
Smiths Industries Medical Systems, Inc.
General Hospital · 43d