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
45097–45120 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2012
PILAIRO NASAL PILLOWS MASK
K120027 · BZD
Fisher & Paykel Healthcare Limited
Anesthesiology · 51d
Cleared Feb 22, 2012
INCONTROL
K110179 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 397d
Cleared Feb 22, 2012
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
K111755 · NOT
Ventana Medical Systems, Inc.
Pathology · 245d
Cleared Feb 22, 2012
SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM
K112679 · LLZ
Materialise Dental NV
Radiology · 161d
Cleared Feb 22, 2012
LEFORTE NEURO SYSTEM BONE PLATE
K112812 · GWO
Jeil Medical Corporation
Neurology · 148d
Cleared Feb 22, 2012
RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS
K113065 · ING
Bella Elevator, LLC
Physical Medicine · 131d
Cleared Feb 22, 2012
SMARTHEART
K113514 · DXH
Shl Telemedicine International , Ltd.
Cardiovascular · 86d
Cleared Feb 22, 2012
INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP
K113570 · LFL
Integra Burlington Ma, Inc.
General & Plastic Surgery · 82d
Cleared Feb 22, 2012
SPECTRA LASER SYSTEM
K113588 · GEX
Lutronic Corporation
General & Plastic Surgery · 79d
Cleared Feb 22, 2012
ASPIRE MAX ASPIRATION CATHETER
K113757 · QEZ
Control Medical Technology, LLC
Cardiovascular · 63d
Cleared Feb 22, 2012
BONETRAP
K120189 · KNW
Berni Farns Incorporated
Gastroenterology & Urology · 30d
Cleared Feb 21, 2012
BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR
K111141 · DXN
Wenzhou Bokang Instruments Co., Ltd.
Cardiovascular · 305d
Cleared Feb 21, 2012
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
K113520 · MED
STERIS Corporation
General Hospital · 84d
Cleared Feb 17, 2012
SIRONA DENTAL CAD/CAM SYSTEM
K111421 · NHA
Sirona Dental Systems GmbH
Dental · 273d
Cleared Feb 17, 2012
VALEO VT-601 SERIES IR THERMOMETER
K111463 · FLL
Valeo Corp.
General Hospital · 267d
Cleared Feb 17, 2012
TI-BASE ABUTMENT, 1 CONNECT ABUTMENT
K111935 · NHA
Nt-Trading GmbH and CO KG
Dental · 224d
Cleared Feb 17, 2012
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
K111976 · LON
bioMerieux, Inc.
Microbiology · 220d
Cleared Feb 17, 2012
GEODESIC EEG MOBILE 100 (GEM 100)
K112353 · GWQ
Electrical Geodesics, Inc.
Neurology · 185d
Cleared Feb 17, 2012
POWDERFREE POLYISOPRENE SURGICAL GLOVES
K112654 · KGO
Pt. Medisafe Technologies
General Hospital · 158d
Cleared Feb 17, 2012
TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
K112781 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 144d
Cleared Feb 17, 2012
EQUIVITAL
K113054 · MHX
Hidalgo Limited
Cardiovascular · 127d
Cleared Feb 17, 2012
NANOBLUTM 500
K113206 · LBI
Draeger Medical Systems, Inc.
General Hospital · 108d
Cleared Feb 17, 2012
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
K113452 · NDN
Ascendx Spine, Inc.
Orthopedic · 88d
Cleared Feb 17, 2012
VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER
K113505 · FMI
Greiner Bio-One North America, Inc.
General Hospital · 81d