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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77281–77304 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2001
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658 · LPH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Dec 05, 2001
GENETRA
K013660 · KXK
Radiomed Corporation
Radiology · 29d
Cleared Dec 05, 2001
CEMENT RESTRICTOR
K013663 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Dec 05, 2001
TRIDENT HEMISPHERICAL ACETABULAR SHELLS
K013676 · MEH
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Dec 05, 2001
MODIFICATION TO XIA SPINAL SYSTEM
K013688 · MNH
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Dec 05, 2001
AUTOGENESIS AUTOMATOR, MODEL M1000
K013818 · JEC
Autogenesis, Inc.
Orthopedic · 19d
Cleared Dec 04, 2001
CTXA HIP
K002113 · KGI
Mindways Software, Inc.
Radiology · 545d
Cleared Dec 04, 2001
RANDOX PHENYTOIN
K011393 · DIP
Randox Laboratories, Ltd.
Toxicology · 211d
Cleared Dec 04, 2001
MILLCOMP
K011845 · IYE
Math Resolutions, LLC
Radiology · 175d
Cleared Dec 04, 2001
CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
K011958 · DCN
Denka Seiken'S
Chemistry · 165d
Cleared Dec 04, 2001
MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
K013013 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 88d
Cleared Dec 04, 2001
SELECTIVA GUIDEWIRE
K013024 · DQX
Neometrics, Inc.
Cardiovascular · 88d
Cleared Dec 04, 2001
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
K013638 · DQY
Guidant Corp.
Cardiovascular · 29d
Cleared Dec 03, 2001
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
K010166 · IWJ
Imagyn Medical Technologies, Inc.
Radiology · 319d
Cleared Dec 03, 2001
LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
K011144 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 231d
Cleared Dec 03, 2001
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K011500 · LCJ
Mentor Corp.
General & Plastic Surgery · 201d
Cleared Dec 03, 2001
MACROPORE SURGIWRAP (TS)
K012025 · FTL
Macropore Biosurgery, Inc.
General & Plastic Surgery · 158d
Cleared Dec 03, 2001
ENT LASERVISION
K012071 · GEX
Union Medical USA
General & Plastic Surgery · 154d
Cleared Dec 03, 2001
COMPANION MODEL 221, 321, 421
K012258 · INI
Golden Technologies, Inc.
Physical Medicine · 138d
Cleared Dec 03, 2001
TRIMAX
K012268 · FYA
Standard Textile Co., Inc.
General Hospital · 137d
Cleared Dec 03, 2001
MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY...
K012380 · HAW
Stryker Leibinger
Neurology · 130d
Cleared Dec 03, 2001
RESORBABLE NO PROFILE SCREW AND WASHER
K012469 · HWC
Biomet Manufacturing, Inc.
Orthopedic · 123d
Cleared Dec 03, 2001
SOFT TISSUE SCREW AND WASHER
K012572 · HWC
Biomet, Inc.
Orthopedic · 116d
Cleared Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · HWC
Synthes (Usa)
Orthopedic · 90d