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

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176,076 results
78409–78432 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 2001
SDI SB OFFICE, MODEL 29-
K011470 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 151d
Cleared Oct 12, 2001
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE...
K012206 · DQK
Cambridge Heart, Inc.
Cardiovascular · 91d
Cleared Oct 12, 2001
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
K012218 · DRO
The Ludlow Company LP
Cardiovascular · 88d
Cleared Oct 12, 2001
OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN...
K012402 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 77d
Cleared Oct 12, 2001
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
K012404 · DRO
Katecho, Inc.
Cardiovascular · 74d
Cleared Oct 12, 2001
BIOMEDICS UV MULTIFOCAL
K012425 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 74d
Cleared Oct 12, 2001
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM,...
K012883 · ESW
Boston Scientific Corp
Gastroenterology & Urology · 45d
Cleared Oct 12, 2001
BIOCUFF,C, MODELS 236018, 236028, 236036
K013057 · MAI
Bionx Implants, Inc.
Orthopedic · 30d
Cleared Oct 12, 2001
LUXAGLAZE
K013179 · EBD
Dmg USA, Inc.
Dental · 18d
Cleared Oct 12, 2001
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE
K013229 · IXA
Ferrania USA, Inc.
Radiology · 15d
Cleared Oct 12, 2001
CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE...
K013286 · LYY
Tillotson Healthcare Corp.
General Hospital · 10d
Cleared Oct 11, 2001
CRYOCARE SURGICAL SYSTEM
K003811 · GEH
Endocare, Inc.
General & Plastic Surgery · 304d
Cleared Oct 11, 2001
EPOCA CUSTOM OFFSET SHOULDER SYSTEM
K010869 · KWT
Argomedical AG
Orthopedic · 202d
Cleared Oct 11, 2001
BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
K011080 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 185d
Cleared Oct 11, 2001
LEVEEN ELECTRODE
K012315 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 80d
Cleared Oct 11, 2001
MODIFICATION TO: COMPEL SURGICAL DRAPES
K012807 · KKX
Standard Textile Co., Inc.
General Hospital · 50d
Cleared Oct 11, 2001
THECURVE, ITEM 507
K012935 · MFD
Select Medical Systems, Inc.
Obstetrics & Gynecology · 41d
Cleared Oct 11, 2001
CANDELA CLEARBEAM PULSED DYE LASER
K013043 · GEX
Candela Corp.
General & Plastic Surgery · 31d
Cleared Oct 10, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 229d
Cleared Oct 10, 2001
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
K010985 · KDI
Gambro Renal Products
Gastroenterology & Urology · 191d
Cleared Oct 10, 2001
MODIFICATION TO A620 EEG
K012011 · HCC
Stoelting Co.
Neurology · 104d
Cleared Oct 10, 2001
WIENER LAB. CREATININA CINETICA AA
K012065 · JFY
Wiener Laboratories Saic
Chemistry · 100d
Cleared Oct 10, 2001
DURACON PS LIPPED TIBIAL INSERT
K012172 · JWH
Howmedica Osteonics
Orthopedic · 90d
Cleared Oct 10, 2001
MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
K012263 · DPS
National Custom Ent., Inc.
Cardiovascular · 84d