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
25993–26016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 2018
g.Estim PRO
K173684 · GYC
G.Tec Medical Engineering GmbH
Neurology · 154d
Cleared May 04, 2018
Wallaby Avenir Coil System
K173711 · HCG
Wallaby Medical, Inc.
Neurology · 151d
Cleared May 04, 2018
StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
K173874 · GAM
Origami Surgical, LLC
General & Plastic Surgery · 134d
Cleared May 04, 2018
NuVasive® XLX Interbody System
K173892 · MAX
Nu Vasive, Incorporated
Orthopedic · 134d
Cleared May 04, 2018
MEDRAD® Imaging Bulk Package Transfer Set
K173913 · PQH
Bayer U.S., LLC
General Hospital · 133d
Cleared May 04, 2018
QT ECG
K180157 · DXH
QT Medical, Inc.
Cardiovascular · 105d
Cleared May 04, 2018
Apollo TMS Therapy System
K180313 · OBP
Mag & More GmbH
Neurology · 88d
Cleared May 04, 2018
EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System,...
K180317 · MBH
Microport Orthopedics, Inc.
Orthopedic · 88d
Cleared May 04, 2018
Hexanium® TLIF
K180437 · MAX
Spinevision, S.A.S.
Orthopedic · 73d
Cleared May 04, 2018
Ulthera System
K180623 · OHV
Ulthera, Inc.
General & Plastic Surgery · 56d
Cleared May 04, 2018
Invenia ABUS Viewer
K180641 · LLZ
Ge Healthcare
Radiology · 53d
Cleared May 04, 2018
VitriGuard
K180740 · MQK
Origio A/S
Obstetrics & Gynecology · 43d
Cleared May 04, 2018
EVOL Spinal Interbody System, EVOS Lumbar Interbody System
K180891 · MAX
Cutting Edge Spine, LLC
Orthopedic · 29d
Cleared May 03, 2018
Fluorescence Mode
K171007 · NBL
Carl Zeiss Suzhou Co., Ltd.
Dental · 394d
Cleared May 03, 2018
Smartcord, Smartcord X
K171577 · MVL
Eastdent Co., Ltd.
Dental · 338d
Cleared May 03, 2018
PIEZOTOME CUBE
K172137 · DZI
Satelec - Acteon Group
Dental · 290d
Cleared May 03, 2018
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
K172777 · BSO
PAJUNK GmbH Medizintechnologie
Anesthesiology · 231d
Cleared May 03, 2018
Micropuncture Pedal Access Set
K172980 · DYB
Cook Incorporated
Cardiovascular · 218d
Cleared May 03, 2018
Brainsway Deep (DTMS) System
K173540 · OBP
Brainsway , Ltd.
Neurology · 169d
Cleared May 03, 2018
CAAS Workstation
K180019 · IZI
Pie Medical Imaging BV
Radiology · 121d
Cleared May 03, 2018
STYLO Interbody Fusion Device
K180071 · MAX
Legend Spine Technologies
Orthopedic · 114d
Cleared May 03, 2018
VivaScope System
K180162 · PSN
Caliber Imaging & Diagnostics, Inc.
General & Plastic Surgery · 104d
Cleared May 03, 2018
Repris Bladder Injection System
K180214 · FBK
Uro-1, Inc.
Gastroenterology & Urology · 98d
Cleared May 03, 2018
Indigo Aspiration System - Modified 110 Aspiration Tubing
K180939 · QEW
Penumbra, Inc.
Cardiovascular · 23d