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
32065–32088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 2016
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K150553 · NEW
Assut Europe
General & Plastic Surgery · 442d
Cleared May 19, 2016
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
K152452 · LEJ
Medtek Lighting Corp D/B/A Peacock...
General & Plastic Surgery · 265d
Cleared May 19, 2016
Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
K152466 · EOQ
Prosurg, Inc.
Ear, Nose, Throat · 262d
Cleared May 19, 2016
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS...
K152842 · JCT
Boston Scientific Corporation
General & Plastic Surgery · 233d
Cleared May 19, 2016
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice...
K153107 · MAX
Choicespine, LP
Orthopedic · 205d
Cleared May 19, 2016
EasyPass Guidewire
K153264 · OCY
Medi-Globe Corporation
Gastroenterology & Urology · 189d
Cleared May 19, 2016
Target Detachable Coils
K153658 · HCG
Stryker Neurovascular
Neurology · 150d
Cleared May 19, 2016
Nester Embolization Coils, Tornado Embolization Coils
K153778 · KRD
Cook Incorporated
Cardiovascular · 140d
Cleared May 19, 2016
Valleylab REM Polyhesive Infant Patient Return Electrode
K160290 · GEI
Covidien, LLC
General & Plastic Surgery · 106d
Cleared May 19, 2016
EMPOWR PS Knee System
K160342 · JWH
Encore Medical, L.P.
Orthopedic · 101d
Cleared May 19, 2016
SmartStart Air/Water and Suction Valves
K160403 · ODC
Endochoice, Inc.
Gastroenterology & Urology · 97d
Cleared May 19, 2016
Navio
K160537 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 83d
Cleared May 19, 2016
C2 CryoBalloon Focal Pear Catheter
K160994 · GEH
C2 Therapeutics, Inc.
General & Plastic Surgery · 41d
Cleared May 19, 2016
OsteoMed ExtremiLOCK Wrist Plating System
K161041 · HRS
Osteomed
Orthopedic · 36d
Cleared May 19, 2016
Nanostim Introducer Kit
K161102 · DYB
St. Jude Medical, Inc.
Cardiovascular · 30d
Cleared May 19, 2016
OptiCross X, 40 MHz Coronary Imaging Catheter
K161125 · OBJ
Boston Scientific Corporation
Cardiovascular · 28d
Cleared May 18, 2016
Vario 8/18/ci
K153663 · BTA
Medela AG
General & Plastic Surgery · 149d
Cleared May 18, 2016
JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector
K160226 · NKB
Implanet, S.A.
Orthopedic · 110d
Cleared May 18, 2016
Stryker SDC3 HD Information Management System with Wireless Device Control...
K160332 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 100d
Cleared May 18, 2016
Mammo Tomosynthesis (MDMG-5221)
K161229 · PGY
Barco N.V.
Radiology · 16d
Cleared May 17, 2016
BIOFOAM Bone Wedge
K152062 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 298d
Cleared May 17, 2016
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
K152657 · LPL
Smart Performer Corp. , Ltd.
Ophthalmic · 244d
Cleared May 17, 2016
SafeCT-29
K153331 · JAK
Medic Vision Imaging Solutions
Radiology · 180d
Cleared May 17, 2016
SiO2 Coated syringe 3 ml
K153553 · FMF
Sio2 Medical Products
General Hospital · 158d