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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
44617–44640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 2012
PRE-LOADED GOLD VISICOIL CK MARKER
K120859 · KXK
Radiomed Corporation
Radiology · 28d
Cleared Apr 19, 2012
WHOLEY GUIDE WIRE SYSTEM
K120863 · DQX
Covidien, LLC
Cardiovascular · 28d
Cleared Apr 19, 2012
ORBIT
K120880 · BZG
National Biomedical, LLC Dba Qrs...
Anesthesiology · 27d
Cleared Apr 19, 2012
ATLAS PTA BALLOON DILATATION CATHETER
K120971 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 17d
Cleared Apr 19, 2012
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K121010 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 16d
Cleared Apr 19, 2012
OPTIMA NM/CT 640
K121019 · KPS
Ge Healthcare
Radiology · 15d
Cleared Apr 18, 2012
WUNDER TEST
K102428 · LDJ
Hien Helen Nguyen
Toxicology · 601d
Cleared Apr 18, 2012
AB DENTAL DEVICES IMPLANTS AND ACCESSORIES
K112440 · DZE
A.B. Dental Devices , Ltd.
Dental · 238d
Cleared Apr 18, 2012
TWIN PEAKS LUMBAR CAGE
K112696 · MAX
Qualgenix, LLC
Orthopedic · 216d
Cleared Apr 18, 2012
ZHENJIANG ASURE MECHANICAL WHEELCHAIR
K112816 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 203d
Cleared Apr 18, 2012
ON CALL CHOSEN LANCING DEVICE
K113332 · FMK
ACON Laboratories, Inc.
General & Plastic Surgery · 156d
Cleared Apr 18, 2012
NEXUS TKO-6, LUER-ACTIVATED DEVICE
K113398 · FPA
Nexus Medical, LLC
General Hospital · 153d
Cleared Apr 18, 2012
JAZZY ELITE 6
K113488 · ITI
Pride Mobility Product Corporration
Physical Medicine · 147d
Cleared Apr 18, 2012
SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS
K113586 · HQD
Synergeyes, Inc.
Ophthalmic · 135d
Cleared Apr 18, 2012
VERSAFITCUP CC TRIO-ADDITIONAL LINERS
K120531 · LZO
Medacta International
Orthopedic · 56d
Cleared Apr 18, 2012
MANTARAY GUIDEWIRES
K120881 · DQX
Bridgepoint Medical
Cardiovascular · 26d
Cleared Apr 17, 2012
IND URINARY TRACT INFECTION (UTI) TEST STRIPS
K103037 · NGJ
Ind Diagnostic, Inc.
Chemistry · 551d
Cleared Apr 17, 2012
LIAC
K110840 · IYE
Sordina S.P.A.
Radiology · 389d
Cleared Apr 17, 2012
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR...
K111999 · JIO
Healgen Scientific, LLC
Chemistry · 279d
Cleared Apr 17, 2012
VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR...
K112305 · EGS
Thunder Tiger Corp.
Dental · 250d
Cleared Apr 17, 2012
RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER...
K112928 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 197d
Cleared Apr 17, 2012
LOFRIC SINGLE USE URINARY CATHETER
K113424 · EZD
Astra Tech AB
Gastroenterology & Urology · 148d
Cleared Apr 17, 2012
NEXTGEN ALTIUS OCT SYSTEM
K113593 · KWP
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 134d
Cleared Apr 17, 2012
AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES
K120028 · LPL
Pegavision Corporation
Ophthalmic · 104d