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
64225–64248 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2005
ONE STEP FSH MENOPAUSAL TEST
K052662 · CGJ
Ind Diagnostic, Inc.
Chemistry · 64d
Cleared Nov 30, 2005
SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR...
K052675 · HQD
Synergeyes
Ophthalmic · 64d
Cleared Nov 30, 2005
LUMINA 1600, 3300 AND 6600 SYSTEMS
K052814 · ILY
Usa Laser Biotech, Inc.
Physical Medicine · 57d
Cleared Nov 30, 2005
SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS...
K052892 · LZA
Barriermed Glove Co.
General Hospital · 47d
Cleared Nov 30, 2005
LIBERTY GLUCOSE CONTROL, MODEL 2120031
K052980 · JJX
Liberty Healthcare Group, Inc.
Chemistry · 37d
Cleared Nov 30, 2005
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
K053082 · GXI
Baylis Medical Co., Inc.
Neurology · 28d
Cleared Nov 30, 2005
DATRIX CARDIO WIFI ELECTROCARDIOGRAPH
K053083 · DPS
Datrix
Cardiovascular · 28d
Cleared Nov 30, 2005
BINAXNOW INFLUENZA A & B TEST
K053126 · PSZ
Binax, Inc.
Microbiology · 23d
Cleared Nov 30, 2005
SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE
K053128 · GEI
Boston Scientific Corp
General & Plastic Surgery · 22d
Cleared Nov 29, 2005
CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN
K051925 · MMI
Access Bio Incorporate
Chemistry · 134d
Cleared Nov 29, 2005
ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX
K052387 · LZB
Arthrex, Inc.
General Hospital · 90d
Cleared Nov 29, 2005
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1,...
K052431 · FPK
Medtronic Minimed
General Hospital · 84d
Cleared Nov 29, 2005
MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1,...
K052432 · FPA
Medtronic Minimed
General Hospital · 84d
Cleared Nov 28, 2005
GYNECARE TVT SECUR SYSTEM
K052401 · PAH
Ethicon, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 28, 2005
BD VIPER SYSTEM
K052481 · LSL
Becton, Dickinson & CO
Microbiology · 80d
Cleared Nov 28, 2005
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · LYZ
Cardinalhealth
General Hospital · 70d
Cleared Nov 28, 2005
QUILL NONABSORBABLE NYLON BARBED SUTURE
K052900 · GAR
Quill Medical, Inc.
General & Plastic Surgery · 45d
Cleared Nov 28, 2005
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
K053059 · JJX
Roche Diagnostics
Chemistry · 28d
Cleared Nov 28, 2005
OPTIUM DBM GEL AND PUTTY
K053098 · MBP
Lifenet
Orthopedic · 25d
Cleared Nov 25, 2005
SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
K051114 · JIF
Sentinel Ch. Srl
Chemistry · 207d
Cleared Nov 25, 2005
INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM
K051821 · OJB
Inion , Ltd.
Orthopedic · 143d
Cleared Nov 25, 2005
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
K052578 · DTK
Bard Peripheral Vascular, Inc.
Cardiovascular · 66d
Cleared Nov 25, 2005
ARTSANA PISTON AND INSULIN SYRINGES
K052667 · FMF
Artsana S.P.A
General Hospital · 59d
Cleared Nov 23, 2005
GRAFTON PLUS DBM PASTE
K043048 · MBP
Osteotech, Inc.
Orthopedic · 384d