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
38641–38664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 2014
HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
K132017 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 267d
Cleared Mar 25, 2014
SOLACE SOUND GENERATORS
K132965 · KLW
Amplisound Hearing Products & Services
Ear, Nose, Throat · 186d
Cleared Mar 25, 2014
ASIR-V
K133640 · JAK
Ge Medical Systems, LLC
Radiology · 118d
Cleared Mar 25, 2014
NIO COLOR 2MP
K133663 · LLZ
Barco N.V.
Radiology · 116d
Cleared Mar 25, 2014
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL...
K133673 · OZZ
Meridian Bioscience, Inc.
Microbiology · 116d
Cleared Mar 25, 2014
ASPIRE CRISTALLE
K133972 · MUE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 89d
Cleared Mar 25, 2014
CAAS WORKSTATION
K133993 · IZI
Pie Medical Imaging
Radiology · 89d
Cleared Mar 25, 2014
SILEX SACROILIAC JOINT FUSION SYSTEM
K140079 · OUR
X-Spine Systems, Inc.
Orthopedic · 71d
Cleared Mar 25, 2014
SAFETY BIOPSY NEEDLE SYSTEM
K140137 · FCG
Pfm Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Mar 25, 2014
RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
K140393 · JJY
Randox Laboratories Limited
Chemistry · 39d
Cleared Mar 25, 2014
CD HORIZON SPINAL SYSTEM
K140449 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Mar 25, 2014
VEGA KNEE SYSTEM
K140452 · JWH
Aesculap Implant Systems
Orthopedic · 29d
Cleared Mar 25, 2014
NAUTILUS SPINAL SYSTEM
K140457 · NKB
Life Spine, Inc.
Orthopedic · 29d
Cleared Mar 24, 2014
RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW
K130550 · PHX
Encore Medical, L.P.
Orthopedic · 385d
Cleared Mar 24, 2014
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
K132250 · JWJ
Integra LifeSciences Corporation
Orthopedic · 248d
Cleared Mar 24, 2014
PRODENSE BONE GRAFT SUBSTITUTE
K132656 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 210d
Cleared Mar 24, 2014
WITHINGS BLOOD PRESURE MONITOR
K133125 · DXN
Withings
Cardiovascular · 175d
Cleared Mar 24, 2014
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA...
K133232 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 154d
Cleared Mar 24, 2014
QB TEST
K133382 · LQD
Qbtech AB
Neurology · 140d
Cleared Mar 24, 2014
IOVERA
K133453 · GXH
Myoscience, Inc.
Neurology · 132d
Cleared Mar 24, 2014
T:SLIM INSULIN DELIVERY SYSTEM
K133593 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 122d
Cleared Mar 24, 2014
VARIAX DISTAL RADIUS PLATING SYSTEM
K133974 · HRS
Stryker Leibinger GmbH
Orthopedic · 88d
Cleared Mar 21, 2014
XTRA
K131553 · CAC
Sorin Group Deutschland GmbH
Anesthesiology · 295d
Cleared Mar 21, 2014
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
K131652 · LAF
Lin-Zhi International, Inc.
Toxicology · 289d