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
32857–32880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2016
BD Vacutainer UltraTouch Push Button Blood Collection Set
K153309 · JKA
Becton, Dickinson and Company
Chemistry · 87d
Cleared Feb 12, 2016
Relieva Scout Multi-Sinus Dilation System
K153341 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 85d
Cleared Feb 12, 2016
WHILL Model M
K153543 · ITI
Whill, Inc.
Physical Medicine · 63d
Cleared Feb 12, 2016
Vitoss BiModal Bone Graft Substitute Foam Strip
K153608 · MQV
Orthovita, Inc.
Orthopedic · 57d
Cleared Feb 12, 2016
Single Use Injector NM600/610
K153625 · FBK
Olympus Medical Systems Corp.
Gastroenterology & Urology · 56d
Cleared Feb 12, 2016
Spirit Hair Removal laser Family
K153718 · GEX
Active Optical Systems , Ltd.
General & Plastic Surgery · 46d
Cleared Feb 12, 2016
TraumaCad Mobile Release 2.0
K160001 · LLZ
Voyant Health, Ltd.
Radiology · 39d
Cleared Feb 12, 2016
Digital Electrocardiograph
K160092 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 28d
Cleared Feb 11, 2016
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension...
K151529 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 248d
Cleared Feb 11, 2016
Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with...
K151918 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 213d
Cleared Feb 11, 2016
ARCHITECT SHBG
K152185 · CDZ
Biokit, S.A.
Chemistry · 190d
Cleared Feb 11, 2016
Dental Implant System
K152555 · DZE
Ariabio International, Inc.
Dental · 156d
Cleared Feb 11, 2016
C-VBR
K152568 · PLR
Cardinal Spine, LLC
Orthopedic · 155d
Cleared Feb 11, 2016
OptoWire Deux
K152991 · DQX
Opsens
Cardiovascular · 121d
Cleared Feb 11, 2016
RTVue XR OCT Avanti with AngioVue Software
K153080 · HLI
Optovue, Inc.
Ophthalmic · 111d
Cleared Feb 11, 2016
ivWatch Model 400
K153605 · PMS
Ivwatch, LLC
General Hospital · 56d
Cleared Feb 10, 2016
Nutra Face Lift Model PE8050
K150826 · NFO
Nutra Luxe MD, LLC
Neurology · 317d
Cleared Feb 10, 2016
Safe Block Pen Needle
K151311 · FMI
Artsana S.P.A
General Hospital · 268d
Cleared Feb 10, 2016
Anterior Cervical Plate System
K151553 · KWQ
Osteomed Implantes, Ltda
Orthopedic · 246d
Cleared Feb 10, 2016
TIO-H DIGITAL RADIOGRAPHY SENSOR
K153144 · MUH
Denttio, Inc.
Radiology · 103d
Cleared Feb 10, 2016
Cios Select
K153232 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Feb 10, 2016
CD HORIZON Spinal System
K153589 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 56d
Cleared Feb 09, 2016
Nutrisafe 2- ENFit Adaptor
K151237 · PIO
Vygon
Gastroenterology & Urology · 274d
Cleared Feb 09, 2016
Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
K151308 · FGA
Schoelly Fiberoptic GmbH
Gastroenterology & Urology · 267d