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
63409–63432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 2006
PROGUIDE NEEDLE SET
K060349 · JAQ
Nucletron Corporation
Radiology · 28d
Cleared Mar 10, 2006
DIGITAL RADIOGRAPHY CXDI-50C
K060433 · MQB
Canon, Inc.
Radiology · 17d
Cleared Mar 10, 2006
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X
K060513 · KWP
Sintea Biotech, Inc.
Orthopedic · 11d
Cleared Mar 09, 2006
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
K051839 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 245d
Cleared Mar 09, 2006
ACCUREX GLUCOSE TEST STRIP
K052207 · CGA
Incline Medical, LLC
Chemistry · 209d
Cleared Mar 09, 2006
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
K053194 · DQK
Biosense Webster, Inc.
Cardiovascular · 114d
Cleared Mar 09, 2006
PROBEAT
K053280 · LHN
Hitachi, Ltd., Power Systems Group
Radiology · 106d
Cleared Mar 09, 2006
THERATRON EQUINOX, MODELS 80 CM AND 100 CM
K053485 · IWB
Mds Nordion, Inc.
Radiology · 84d
Cleared Mar 09, 2006
CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM
K053488 · NPJ
Conformis, Inc.
Orthopedic · 84d
Cleared Mar 09, 2006
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
K053553 · DCF
Polymedco, Inc.
Chemistry · 79d
Cleared Mar 09, 2006
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
K053645 · DWJ
Arizant Healthcare, Inc.
Cardiovascular · 69d
Cleared Mar 09, 2006
ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
K060023 · FGE
AngioDynamics, Inc.
Gastroenterology & Urology · 64d
Cleared Mar 09, 2006
MDXNET
K060035 · LLZ
Cybermdx, Inc.
Radiology · 63d
Cleared Mar 09, 2006
QUICKCAT EXTRACTION CATHETER
K060092 · QEZ
Kensey Nash Corp.
Cardiovascular · 56d
Cleared Mar 09, 2006
BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP...
K060214 · LON
Becton, Dickinson & CO
Microbiology · 41d
Cleared Mar 09, 2006
DIMENSION IRON CALIBRATOR
K060266 · JIS
Dade Behring, Inc.
Chemistry · 36d
Cleared Mar 09, 2006
FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA...
K060338 · GEX
Lumenis, Inc.
General & Plastic Surgery · 27d
Cleared Mar 09, 2006
THE EMIT 2000 TACROLIMUS CALIBRATORS
K060371 · JIT
Dade Behring, Inc.
Chemistry · 24d
Cleared Mar 09, 2006
VITREA2 VERSION 3.8.1
K060378 · LLZ
Vital Images, Inc.
Radiology · 23d
Cleared Mar 09, 2006
LYSUS INFUSION SYSTEM
K060422 · QEY
Ekos Corp.
Cardiovascular · 20d
Cleared Mar 09, 2006
LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
K060426 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 16d
Cleared Mar 09, 2006
AZE VIRTUALPLACE
K060453 · LLZ
Aze, Ltd.
Radiology · 15d
Cleared Mar 09, 2006
LIBERTY GLUCOSE CONTROL SOLUTION
K060481 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 14d
Cleared Mar 08, 2006
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400,...
K050709 · GKA
Wallac OY
Hematology · 355d