FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
23497–23520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2019
Parcus Twist AP Suture Anchors
K183501 · MAI
Parcus Medical, LLC
Orthopedic · 88d
Cleared Mar 15, 2019
Vantage Galan 3T, MRT-3020/A9, V5.0
K183657 · LNH
Canon Medical Systems Corporation
Radiology · 78d
Cleared Mar 15, 2019
Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope,...
K190099 · FJL
Corinth Medtech, Inc.
Gastroenterology & Urology · 52d
Cleared Mar 15, 2019
Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee...
K190280 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 35d
Cleared Mar 15, 2019
CELL-DYN Emerald 22 AL System
K190294 · GKZ
Abbott Laboratories
Hematology · 32d
Cleared Mar 15, 2019
HIVOX OTC Electrical Stimulator
K190347 · NUH
Hivox Biotek, Inc.
Neurology · 29d
Cleared Mar 15, 2019
Star-X, Intraoral X-ray System
K190357 · EHD
Hdx Will Corp.
Radiology · 28d
Cleared Mar 15, 2019
SonialVision G4
K190373 · JAA
Shimadzu Corporation
Radiology · 24d
Cleared Mar 15, 2019
MAMBA and MAMBA Flex Microcatheters
K190401 · DQY
Boston Scientific Corporation
Cardiovascular · 24d
Cleared Mar 15, 2019
FUJIFILM Sonosite Vevo MD Imaging System
K190476 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 16d
Cleared Mar 14, 2019
EUROPA Pedicle Screw System
K180337 · NKB
MiRus, LLC
Orthopedic · 400d
Cleared Mar 14, 2019
ConvertX Biliary Stent System
K181669 · FGE
Brightwater Medical
Gastroenterology & Urology · 262d
Cleared Mar 14, 2019
JKH Stimulator Plus
K182203 · NUH
Jkh USA, LLC
Neurology · 211d
Cleared Mar 14, 2019
da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
K182371 · NAY
Intuitive Surgical, Inc.
Ear, Nose, Throat · 195d
Cleared Mar 14, 2019
Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0...
K182475 · GDW
Covidien
General & Plastic Surgery · 185d
Cleared Mar 14, 2019
Omron Model BP7900 Blood Pressure Monitor + EKG
K182579 · DXN
Omron Healthcare, Inc.
Cardiovascular · 176d
Cleared Mar 14, 2019
BD Plastipak Syringe
K182589 · FMF
Becton, Dickinson and Company
General Hospital · 175d
Cleared Mar 14, 2019
PathVisionXL
K183142 · MWP
Faxitron Bioptics, LLC
Radiology · 121d
Cleared Mar 14, 2019
dpl Faceware
K183247 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 113d
Cleared Mar 14, 2019
Tetric PowerFill
K183380 · EBF
Ivoclar Vivadent, AG
Dental · 98d
Cleared Mar 14, 2019
Vstrip H. pylori Antigen Rapid Test
K183573 · LYR
Panion & BF Biotech, Inc.
Microbiology · 83d
Cleared Mar 14, 2019
Aquas Probes
K190168 · GEI
Genicon, Inc.
General & Plastic Surgery · 42d
Cleared Mar 14, 2019
PROSTIM Injectable Inductive Graft
K190283 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared Mar 14, 2019
L300 Go System
K190285 · GZI
Bioness, Inc.
Neurology · 31d