Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
77881–77904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2001
MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
K012014 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 176d
Cleared Dec 05, 2001
ACCU-CHEK ACTIVE TEST SYSTEM
K012324 · NBW
Roche Diagnostics Corp.
Chemistry · 135d
Cleared Dec 05, 2001
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302,...
K012988 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 90d
Cleared Dec 05, 2001
MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
K013000 · GXN
Medtronic Neurosurgery
Neurology · 90d
Cleared Dec 05, 2001
FOCAL SIM
K013112 · MUJ
Computerized Medical Systems, Inc.
Radiology · 78d
Cleared Dec 05, 2001
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
K013211 · KWY
Exactech, Inc.
Orthopedic · 70d
Cleared Dec 05, 2001
TCI-31 LIFELONG OVULATION TESTER
K013323 · CEP
Tci New York
Chemistry · 61d
Cleared Dec 05, 2001
ISITE RADIOLOGY
K013630 · LLZ
Stentor, Inc.
Radiology · 30d
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