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"
889–912 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jun 29, 1994
SMITH AND NEPHEW SPINE DEFLECTING FORCEPS
K940222 · HRX
Smith & Nephew, Inc.
Orthopedic · 162d
Cleared Jun 15, 1994
VARIABLE ANGULAR HOLD BONE PLATE SYSTEM
K930480 · HRS
Smith & Nephew Richards, Inc.
Orthopedic · 502d
Cleared Jun 08, 1994
BLACK OVAL-TOP TORP/PORP
K934107 · ETA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 289d
Cleared May 19, 1994
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · IPF
Smith & Nephew, Inc.
Physical Medicine · 73d
Cleared May 18, 1994
FLEXSURE HP
K934863 · LYR
Smithkline Diagnostics, Inc.
Microbiology · 218d
Cleared May 06, 1994
REFLECTION ACETABULAR COMPONENT
K932755 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 350d
Cleared Apr 29, 1994
RMHS MONOLITHIC FEMORAL COMPONENT
K931642 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 392d
Cleared Apr 25, 1994
OTOVIEW ENDOSCOPY SYSTEM
K934432 · EWA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 224d
Cleared Apr 25, 1994
ZIRCONIUM ALLOY UNI-POLAR HEAD
K934353 · KWL
Smith & Nephew Richards, Inc.
Orthopedic · 229d
Cleared Mar 29, 1994
MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY
K922519 · HRX
Smith & Nephew, Inc.
Orthopedic · 685d
Cleared Mar 23, 1994
PERCUTANEOUS TRACHEOSTOMY KIT
K936133 · JOH
Smiths Industries Medical Systems, Inc.
Anesthesiology · 90d
Cleared Mar 18, 1994
BRACE NEUTRALIZER
K932592 · GZJ
Smith and Nephew Donjoy, Inc.
Neurology · 294d
Cleared Mar 17, 1994
HA TI-FIT ACETABULAR AND FEMORAL COMPONENT
K922621 · MEH
Smith & Nephew Richards, Inc.
Orthopedic · 652d
Cleared Mar 10, 1994
ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM
K934044 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 203d
Cleared Mar 10, 1994
ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW
K932862 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 272d
Cleared Mar 10, 1994
RMHS POROUS DISTAL SLEEVE
K932574 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 287d
Cleared Feb 28, 1994
SHARPSAFE, CAT. NO. 4125
K935777 · FMI
Smiths Industries Medical Systems, Inc.
General Hospital · 87d
Cleared Feb 28, 1994
SHARPSAFE, CAT. NO. 4126
K935776 · FMI
Smiths Industries Medical Systems, Inc.
General Hospital · 87d
Cleared Feb 22, 1994
THE MODULAR NAIL
K933027 · HSB
Smith & Nephew Richards, Inc.
Orthopedic · 245d
Cleared Feb 22, 1994
ZIRCONIA CERAMIC FEMORAL HEAD
K930788 · LZO
Smith & Nephew Richards, Inc.
Orthopedic · 371d
Cleared Feb 15, 1994
ALLEVYN ISLAND WOUND DRESSING
K935705 · NAE
Smith & Nephew United, Inc.
General & Plastic Surgery · 77d
Cleared Feb 15, 1994
EXTRACORPOREAL TEMPERATURE SENSOR
K935603 · FLL
Smiths Industries Medical Systems, Inc.
General Hospital · 89d
Cleared Feb 14, 1994
DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION
K934299 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 165d
Cleared Feb 04, 1994
SHARPSAFE CAT. NO. 4127
K935628 · FMI
Smiths Industries Medical Systems, Inc.
General Hospital · 73d