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
30913–30936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 2016
FTRD System Set
K153550 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 306d
Cleared Oct 12, 2016
Spetzler Malis Dual Illuminating Bipolar Forceps
K160103 · GEI
Synergetics
General & Plastic Surgery · 267d
Cleared Oct 12, 2016
ClearPetra Suction-Evacuation Sheath
K161110 · FED
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 175d
Cleared Oct 12, 2016
Navien Intracranial Support Catheter
K161152 · DQY
Micro Therapeutics, Inc. d/b/a ev3...
Cardiovascular · 170d
Cleared Oct 12, 2016
FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
K161815 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 103d
Cleared Oct 12, 2016
Toricolors (hioxifilcon D) Soft Contact Lenses
K161931 · LPL
Polydev , Ltd.
Ophthalmic · 90d
Cleared Oct 12, 2016
Stryker OrthoMap Precision Knee system
K162341 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 51d
Cleared Oct 12, 2016
Express SD Biliary Monorail Premounted Stent System
K162404 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 44d
Cleared Oct 12, 2016
Ulna Plating System
K162424 · HRS
Biomet, Inc.
Orthopedic · 43d
Cleared Oct 12, 2016
Medtronic Model 5392 External Pulse Generator (EPG)
K162550 · DTE
Medtronic, Inc.
Cardiovascular · 29d
Cleared Oct 11, 2016
HammerTech Fixation System
K161449 · HWC
Fusion Orthopedics, LLC
Orthopedic · 139d
Cleared Oct 11, 2016
IcePearl 2.1 CX L, IceForce 2.1 CX L
K162599 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 22d
Cleared Oct 07, 2016
AUTION ELEVEN Semi-Automated Urinalysis System
K160062 · JIL
Arkray, Inc.
Chemistry · 269d
Cleared Oct 07, 2016
Prestige Ameritech Pediatric/Child’s Face mask
K160100 · OXZ
Prestige Ameritech
General Hospital · 262d
Cleared Oct 07, 2016
SpiroScout
K160116 · BZG
Ganshorn Medizin Electronic GmbH
Anesthesiology · 262d
Cleared Oct 07, 2016
EnSite Velocity Surface Electrode Kit
K160186 · DQK
St Jude Medical
Cardiovascular · 254d
Cleared Oct 07, 2016
Cryotop Vitrification Kit and Cryotop Thawing Kit
K160864 · MQL
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 192d
Cleared Oct 07, 2016
Sterilization Tray
K160912 · KCT
STERIS Corporation
General Hospital · 189d
Cleared Oct 07, 2016
Pantera Pro
K160985 · LOX
Biotronik, Inc.
Cardiovascular · 182d
Cleared Oct 07, 2016
PK Morcellator
K161038 · GEI
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 177d
Cleared Oct 07, 2016
Turbo-Flo PICC Sets
K161496 · LJS
Cook Incorporated
General Hospital · 128d
Cleared Oct 07, 2016
CAVUX™ Cervical Cage
K161642 · ODP
Providence Medical Technology, Inc.
Orthopedic · 115d
Cleared Oct 07, 2016
Straumann Sterile Healing Solution
K161677 · NHA
Institut Straumann AG
Dental · 112d
Cleared Oct 07, 2016
Pyrenees Cervical Plate System
K162664 · KWQ
K2m, Inc.
Orthopedic · 11d