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
31393–31416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 2016
NICO TRIOwand
K162075 · GEI
Nico Corporation
General & Plastic Surgery · 15d
Cleared Aug 11, 2016
Laparoscopic Spray Applicator with Spinning Luers
K162077 · GCJ
Micromedics, Inc. (D/B/A Nordson...
General & Plastic Surgery · 15d
Cleared Aug 10, 2016
Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with...
K152834 · KPL
Colonplus Equipments & Speculums, S.L.
Gastroenterology & Urology · 316d
Cleared Aug 10, 2016
EUROIMMUN Anti-West Nile Virus ELISA (IgG)
K153303 · NOP
Euroimmun Us, Inc.
Microbiology · 268d
Cleared Aug 10, 2016
CT TrueView
K160147 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 202d
Cleared Aug 10, 2016
TAP 3, TAP 1
K160239 · PLC
Airway Management, Inc.
Dental · 191d
Cleared Aug 10, 2016
Hidrocor, Hidrocharme, and Natural Colors
K160472 · LPL
Solotica
Ophthalmic · 173d
Cleared Aug 10, 2016
Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator...
K160516 · JAQ
Varian Medical Systems, Inc.
Radiology · 168d
Cleared Aug 10, 2016
Fully Automatic Electronic Blood Pressure Monitor
K160565 · DXN
Andon Health Co, Ltd.
Cardiovascular · 163d
Cleared Aug 10, 2016
MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
K160648 · FPA
Unomedical A/S
General Hospital · 156d
Cleared CT Aug 10, 2016
SpotLight CT
K161066 · JAK
Arineta , Ltd.
Radiology · 117d
Cleared Aug 10, 2016
Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses
K161100 · HQD
Contamac, Ltd.
Ophthalmic · 113d
Cleared Aug 10, 2016
Rhythm View Workstation (non-streaming)
K161240 · DQK
Abbott Electrophysiology
Cardiovascular · 100d
Cleared Aug 10, 2016
Affirm Lateral Arm Upright Biopsy Accessory
K161575 · IZH
Hologic
Radiology · 64d
Cleared Aug 10, 2016
Audit MicroControls Linearity DROP LQ Blood Glucose
K161874 · JJX
Aalto Scientific, Ltd.
Chemistry · 33d
Cleared Aug 10, 2016
5D Viewer
K161955 · LLZ
Samsung Medison Co., Ltd.
Radiology · 23d
Cleared Aug 09, 2016
Quantitative Electrocardiographic Detector (QED 2000)
K152135 · DPS
Acme Portable Machines, Inc.
Cardiovascular · 375d
Cleared Aug 09, 2016
Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
K152224 · LHN
Ion Beam Application S.A.
Radiology · 368d
Cleared Aug 09, 2016
SnoreRx
K153200 · LRK
Apnea Sciences Corporation
Dental · 279d
Cleared Aug 09, 2016
ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator,...
K153596 · POX
ARK Diagnostics, Inc.
Toxicology · 237d
Cleared Aug 09, 2016
Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube...
K160787 · KNT
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 140d
Cleared Aug 09, 2016
NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm,...
K161026 · MSD
Marvao Medical Devices, Ltd.
Gastroenterology & Urology · 119d
Cleared Aug 09, 2016
icobrain
K161148 · LLZ
Icometrix
Radiology · 109d
Cleared Aug 09, 2016
Genesys Spine TiLock Cortical Spinal System
K161914 · NKB
Genesys Spine
Orthopedic · 28d