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
45577–45600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 2011
COLS PEEK
K113591 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 17d
Cleared Dec 21, 2011
AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN...
K110794 · FOZ
Ameco Medical Industries
General Hospital · 274d
Cleared Dec 21, 2011
GALAXY SYSTEM
K111055 · OLV
Personal Health Institute International
Neurology · 250d
Cleared Dec 21, 2011
DERMATOLOGICAL TREATMENT DEVICE FAMILY
K111303 · GEX
Sharplight Technologies, Ltd.
General & Plastic Surgery · 226d
Cleared Dec 21, 2011
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
K111446 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 211d
Cleared Dec 21, 2011
U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM
K112274 · DXN
Taidoc Technology Corporation
Cardiovascular · 135d
Cleared Dec 21, 2011
PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC,...
K112302 · LPL
CooperVision, Inc.
Ophthalmic · 132d
Cleared Dec 21, 2011
FM-9000 PLUS FETAL AND MATERNAL MONITOR
K112317 · HGM
Advanced Instrumentations, Inc.
Obstetrics & Gynecology · 132d
Cleared Dec 21, 2011
ARTHREX FRACTURE SYSTEM
K112437 · HTN
Arthrex, Inc.
Orthopedic · 119d
Cleared Dec 21, 2011
XPRESS MULTI-SINUS DILATION TOOL
K112506 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 113d
Cleared Dec 21, 2011
FUKUDA DENSHI VASERA MODEL VS-1500
K112521 · DXN
Fukuda Denshi USA, Inc.
Cardiovascular · 112d
Cleared Dec 21, 2011
AUREFLO MONITORING SYSTEM
K112657 · DPW
Transonic Systems, Inc.
Cardiovascular · 99d
Cleared Dec 21, 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112920 · MNI
K2m, Inc.
Orthopedic · 79d
Cleared Dec 21, 2011
SYNTHES MIRS
K113044 · NKB
Synthes Spine
Orthopedic · 70d
Cleared Dec 21, 2011
EMBRYO VIEWER SOFTWARE
K113075 · MQG
Unisense Fertilitech A/S
Obstetrics & Gynecology · 65d
Cleared CT Dec 21, 2011
MYSENSE HEART
K113176 · DSH
Cardiac Science Corporation
Cardiovascular · 54d
Cleared Dec 21, 2011
SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
K113251 · JEY
Synthes, Inc.
Dental · 48d
Cleared Dec 21, 2011
FRESENIUS 2008T HEMODIALYSIS MACHINE
K113427 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Dec 21, 2011
N-HYBRIDE-COMPOSITE LC FLOW
K113444 · EBF
Voco GmbH
Dental · 30d
Cleared Dec 21, 2011
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K113479 · OOE
Optimedica Corporation
Ophthalmic · 28d
Cleared Dec 21, 2011
TCX-I REMOTE CARE MANAGEMENT SYSTEM
K113493 · DRG
Bl Healthcare, Inc.
Cardiovascular · 26d
Cleared Dec 21, 2011
N-HYBRIDE-COMPOSITE LC
K113563 · EBF
Voco GmbH
Dental · 30d
Cleared Dec 20, 2011
FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K101926 · NBW
Taidoc Technology Corporation
Chemistry · 529d
Cleared CT Dec 20, 2011
DUOFERTILITY
K102499 · LHD
Cambridge Temperature Concepts , Ltd.
Obstetrics & Gynecology · 476d