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
37081–37104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2014
ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
K141670 · LPL
Johnson & Johnson Vision Care, Inc.
Ophthalmic · 87d
Cleared Sep 18, 2014
EDWARDS ESHEATH INTRODUCER SET
K141696 · DYB
Edwards Lifesciences
Cardiovascular · 86d
Cleared Sep 18, 2014
XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K141697 · KTT
Zimmer, Inc.
Orthopedic · 86d
Cleared Sep 18, 2014
CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY
K141885 · IZL
Minxray, Inc.
Radiology · 69d
Cleared Sep 18, 2014
MOBILEDIAGNOST WDR
K141895 · IZL
Sedecal., Sa.
Radiology · 66d
Cleared Sep 18, 2014
TRUE BA V BALLOON VALVULOPLASTY CATHETER
K141985 · OZT
C.R. Bard, Inc.
Cardiovascular · 58d
Cleared Sep 18, 2014
RANDOX ALDOLASE CALIBRATION SERUM
K142181 · JIT
Randox Laboratories Limited
Chemistry · 41d
Cleared Sep 18, 2014
Veenstra Instruments VDC-506 Dose Calibrator
K142325 · KPT
Comecer Netherlands B.V.
Radiology · 29d
Cleared Sep 17, 2014
DA VINVI SURGICAL SYSTEM
K123329 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 691d
Cleared Sep 17, 2014
TRANSONIC HCM 103 SYSTEM
K134035 · DXG
Transonic Systems, Inc.
Cardiovascular · 260d
Cleared Sep 17, 2014
TREKKER, TREKKER TRANSIT
K140416 · IOR
Convaid Products, Inc.
Physical Medicine · 211d
Cleared Sep 17, 2014
Lung Density Analysis
K141069 · JAK
Imbio, LLC
Radiology · 146d
Cleared Sep 17, 2014
ELECTRONIC PULSE STIMULATOR
K141260 · NUH
Shenzhen Jingkehui Electronic Co.., Ltd.
Neurology · 125d
Cleared Sep 17, 2014
AXIOM 2.8
K141450 · DZE
Anthogyr Sas
Dental · 107d
Cleared Sep 17, 2014
TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
K141481 · HKI
Topcon Corporation
Ophthalmic · 105d
Cleared Sep 17, 2014
PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
K141638 · HLI
Propper Manufacturing Co., Inc.
Ophthalmic · 90d
Cleared Sep 17, 2014
EMPRINT PROCEDURE PLANNING APPLICATION
K142048 · LLZ
Covidien, LLC
Radiology · 51d
Cleared Sep 17, 2014
D-KAT Z-YPE
K142179 · HKY
Keeler, Ltd.
Ophthalmic · 40d
Cleared Sep 17, 2014
Arrow GPSCath Balloon Dialation Catheter (150 cm)
K142300 · LIT
Hotspur Technologies, Inc.,
Cardiovascular · 30d
Cleared Sep 17, 2014
GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose...
K142336 · CGA
Arkray Factory, Inc.
Chemistry · 27d
Cleared Sep 16, 2014
TRANSONIC HCM 102 SYSTEM
K140017 · DXG
Transonic Systems, Inc.
Cardiovascular · 257d
Cleared CT Sep 16, 2014
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR...
K140377 · PCH
Luminex Molecular Diagnostics, Inc.
Microbiology · 214d
Cleared Sep 16, 2014
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access...
K140496 · CDD
Beckman Coulter, Inc.
Chemistry · 201d
Cleared Sep 16, 2014
YUSHENG
K141108 · LYZ
Zibo Yusheng Plastic Products Co., Ltd.
General Hospital · 140d