FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
22897–22920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2019
TCAT (R) THA Instrument Tray Set
K180127 · KCT
THINK Surgical, Inc.
General Hospital · 422d
Cleared Mar 15, 2019
MTF Pre-Sutured Tendon
K181633 · GAT
Musculoskeletal Transplant Foundation
General & Plastic Surgery · 268d
Cleared Mar 15, 2019
ApexMV
K182022 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 231d
Cleared Mar 15, 2019
CardioFlux with Faraday Analytical Cloud
K182571 · DPS
Genetesis, Inc.
Cardiovascular · 178d
Cleared Mar 15, 2019
MOBILETT Elara Max
K182639 · IZL
Siemens Medi Cal Solutions, Inc.
Radiology · 172d
Cleared Mar 15, 2019
COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
K182813 · HEB
Cotton High Tech S.L.
Obstetrics & Gynecology · 163d
Cleared Mar 15, 2019
HORIZON TMS Therapy System
K182853 · OBP
Magstim Company, Ltd.
Neurology · 156d
Cleared Mar 15, 2019
nextaro Transfer System, nextaro va
K183187 · LHI
Sfm Medical Devices GmbH
General Hospital · 116d
Cleared Mar 15, 2019
MectaLIF Anterior Stand Alone Extension
K183426 · OVD
Medacta International S.A.
Orthopedic · 94d
Cleared Mar 15, 2019
SelectSite C304-HIS Deflectable Catheter System
K183493 · DQY
Medtronic, Inc.
Cardiovascular · 88d
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