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
32953–32976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2016
PICO Single Use Negative Pressure Wound Therapy System
K151436 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 245d
Cleared Jan 28, 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716 · HRS
Zimmer, Inc.
Orthopedic · 217d
Cleared Jan 28, 2016
QUAD Dental Implants and Prostheses
K152188 · DZE
Dentack Impants, Ltd.
Dental · 176d
Cleared Jan 28, 2016
Total Bilirubin
K152344 · JFM
Randox Laboratories Limited
Chemistry · 162d
Cleared Jan 28, 2016
Half Dome Posterior Lumbar Interbody System
K152512 · MAX
Astura Medical
Orthopedic · 148d
Cleared Jan 28, 2016
dynaMX Tabbed Staple
K153129 · JDR
Mx Orthopedics, Corp.
Orthopedic · 90d
Cleared Jan 28, 2016
Adjustable Fixation Device
K153186 · MBI
Arthrocare Corp.
Orthopedic · 86d
Cleared Jan 28, 2016
CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
K153423 · LJS
Arrow International, Inc. (Subsidiary...
General Hospital · 64d
Cleared Jan 28, 2016
TACVAC
K153459 · BTA
Athena Gtx
General & Plastic Surgery · 58d
Cleared Jan 28, 2016
Seneka II Polyscrew Pedicle Fixation System
K153525 · NKB
Senecka Spine
Orthopedic · 50d
Cleared Jan 28, 2016
SPIWay Endonasal Access Guide
K153686 · LYA
Spiway, LLC
Ear, Nose, Throat · 36d
Cleared Jan 28, 2016
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7...
K153712 · JJY
Radiometer America, Inc.
Chemistry · 35d
Cleared Jan 27, 2016
VistaCam iX Proof
K150672 · NBL
Durr Dental AG
Dental · 317d
Cleared Jan 27, 2016
Cervello STIM
K151354 · GYC
Blackrock Neuromed
Neurology · 252d
Cleared Jan 27, 2016
Sydney IVF Hyaluronidase
K151367 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 251d
Cleared Jan 27, 2016
Holter System
K151787 · DQK
Edan Instruments, Inc.
Cardiovascular · 210d
Cleared Jan 27, 2016
BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New...
K152233 · LEJ
Sportarredo Group S.C.
General & Plastic Surgery · 173d
Cleared Jan 27, 2016
StatStrip Xpress 2 Glucose Hospital Meter System
K152986 · PZI
Nova Biomedical Corporation
Chemistry · 110d
Cleared Jan 27, 2016
Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF...
K153290 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 75d
Cleared Jan 27, 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
K153500 · FZP
AtriCure, Inc.
General & Plastic Surgery · 51d
Cleared Jan 27, 2016
8F FlowGate2 Balloon Guide Catheter
K153729 · DQY
Concentric Medical
Cardiovascular · 30d
Cleared Jan 26, 2016
Antistatic Compact Space Chamber
K143615 · NVP
Medical Developments International...
Anesthesiology · 403d
Cleared Jan 26, 2016
Discovery 24
K150498 · GWQ
Brainmaster Technologies, Inc.
Neurology · 334d
Cleared Jan 26, 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
K151259 · JPA
Siemens Healthcare Diagnostics...
Hematology · 259d