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
62041–62064 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2006
XCAT
K061834 · JAK
Xoran Technologies, Inc.
Radiology · 39d
Cleared Aug 07, 2006
MONOCHROME LCD MONITOR, RADIFORCE, GS320
K062053 · LLZ
Eizo Nanao Corporation
Radiology · 18d
Cleared Aug 07, 2006
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
K062055 · JIX
Dade Behring, Inc.
Chemistry · 18d
Cleared Aug 04, 2006
STRYKER ORTHOPAEDICS RFID INSTRUMENTATION
K053348 · HAW
Howmedica Osteonics Corp.
Neurology · 245d
Cleared Aug 04, 2006
VERSALET 7700 CARE CENTER
K053399 · FMZ
Draeger Medical Infant Care, Inc.
General Hospital · 241d
Cleared Aug 04, 2006
NAUTIFLUX
K060010 · DQO
Sedat
Cardiovascular · 213d
Cleared Aug 04, 2006
ENDO-EASE ENDOSCOPIC OVERTUBE
K060235 · FDA
Spirus Medical, Inc.
Gastroenterology & Urology · 186d
Cleared Aug 04, 2006
12 RL ALGORITHM
K060307 · DRT
Ge Medical Systems Information...
Cardiovascular · 178d
Cleared Aug 04, 2006
MARATHON STENT WITH FUSION TECHNOLOGY
K060624 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 149d
Cleared Aug 04, 2006
KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE...
K060972 · MSD
Kendall
Gastroenterology & Urology · 119d
Cleared Aug 04, 2006
HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS
K061450 · DQE
Hospira, Inc.
Cardiovascular · 71d
Cleared Aug 04, 2006
SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
K061589 · FTC
Solarc Systems, Inc.
General & Plastic Surgery · 57d
Cleared Aug 04, 2006
BEST STRAND AND BEST SPACER
K061638 · KXK
Best Medical International, Inc.
Radiology · 53d
Cleared Aug 04, 2006
OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
K061730 · CEM
Osmetech, Inc.
Chemistry · 45d
Cleared Aug 04, 2006
SYNTHES (USA) CLAVICLE HOOK PLATES
K061753 · HRS
Synthes (Usa)
Orthopedic · 44d
Cleared Aug 04, 2006
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
K061779 · HSX
Smith & Nephew, Inc.
Orthopedic · 39d
Cleared Aug 04, 2006
SONIX ULTRASOUND SCANNER
K061827 · IYN
Ultrasonix Medical Corporation
Radiology · 37d
Cleared Aug 04, 2006
RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS
K061955 · HRS
Creative Medical Designs, Inc.
Orthopedic · 24d
Cleared Aug 04, 2006
MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00,...
K061963 · DQO
Micrus Endovascular Corporation
Cardiovascular · 23d
Cleared Aug 04, 2006
PRODRIVE SYSTEMS REPLACEMENT TURBINE
K062219 · EFB
Prodrive Systems, Inc.
Dental · 2d
Cleared Aug 03, 2006
LISFRANC PLATE
K060474 · HRS
New Deal, S.A.
Orthopedic · 161d
Cleared Aug 03, 2006
FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER
K061015 · DYB
St Jude Medical
Cardiovascular · 112d
Cleared Aug 03, 2006
ELIA CCP, MODEL 14-5515-01
K061165 · NHX
Sweden Diagnostics (Us), Inc.
Immunology · 99d
Cleared Aug 03, 2006
VECTORS TEMPORARY ANCHORAGE SYSTEM
K061230 · OAT
Sybron Dental Specialties
Dental · 93d