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
70849–70872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 2003
ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
K032784 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 71d
Cleared Nov 18, 2003
PASCO MIC AND MIC/ID PANELS
K033119 · JWY
Pasco Laboratories, Inc.
Microbiology · 49d
Cleared Nov 18, 2003
BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
K033350 · FPA
Becton, Dickinson & CO
General Hospital · 29d
Cleared Nov 18, 2003
MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
K033473 · LJT
Horizon Medical Products, Inc.
General Hospital · 15d
Cleared Nov 17, 2003
STONE EXTRACTOR BALLOON CATHETER
K011261 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 936d
Cleared Nov 17, 2003
AURA ISURGICAL LASER SYSTEM & ACCESSORIES
K024206 · GEX
Laserscope
General & Plastic Surgery · 332d
Cleared Nov 17, 2003
GYRUS OPEN FORCEPS
K024286 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 329d
Cleared Nov 17, 2003
ARTELON SURGICAL SUTURE
K032160 · GAR
Artimplant AB
General & Plastic Surgery · 125d
Cleared Nov 17, 2003
CYNOSURE PHOTOGENICA SV LASER
K032539 · GEX
Cynosure, Inc.
General & Plastic Surgery · 91d
Cleared Nov 17, 2003
CAPROSYN ABSORBABLE SUTURE
K032586 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 87d
Cleared Nov 17, 2003
ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
K032987 · JHI
Unotech Diagnostics, Inc.
Chemistry · 54d
Cleared Nov 17, 2003
ORTHODEK
K033115 · GAM
Teleflex Medical
General & Plastic Surgery · 48d
Cleared Nov 17, 2003
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
K033134 · FGE
Ev3, Inc.
Gastroenterology & Urology · 48d
Cleared Nov 14, 2003
ACCUMAP AUTOMATIC PERIMETER
K022304 · GWE
Objectivision Pty , Ltd.
Neurology · 486d
Cleared Nov 14, 2003
SHILEY FLEXTRA TRACHEOSTOMY TUBE
K030787 · JOH
Nellcor Puritan Bennett, Inc.
Anesthesiology · 247d
Cleared Nov 14, 2003
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · BTR
C.R. Bard, Inc.
Anesthesiology · 247d
Cleared Nov 14, 2003
KWIKEZE MALE CONDOM APPLICATOR
K031007 · HIS
Condax, LLC
Obstetrics & Gynecology · 228d
Cleared Nov 14, 2003
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100
K031024 · BZH
Microlife Corp.
Anesthesiology · 228d
Cleared Nov 14, 2003
CLICK'X MONOAXIAL SCREWS AND HOOKS
K031175 · KWP
Synthes (Usa)
Orthopedic · 214d
Cleared Nov 14, 2003
AUTO-BAND LIGATOR
K031236 · MND
Scandimed. A.S.
Gastroenterology & Urology · 210d
Cleared Nov 14, 2003
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR,...
K031380 · LCP
Olympus America, Inc.
Chemistry · 197d
Cleared Nov 14, 2003
SPIROPRO SPO2
K031515 · DQA
Viasys Healthcare GmbH
Anesthesiology · 184d
Cleared Nov 14, 2003
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03
K031646 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 170d
Cleared Nov 14, 2003
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
K031965 · MHJ
Remel, Inc.
Microbiology · 141d