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
26329–26352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2018
Zimmer Knee Joint Replacement Prostheses MR Labeling
K173057 · JWH
Zimmer, Inc.
Orthopedic · 182d
Cleared Mar 29, 2018
Arco™-SA Lumbar Cage System
K173082 · OVD
Neurostructures, Inc.
Orthopedic · 181d
Cleared Mar 29, 2018
Bloom2 Programmable Electrophysiology Stimulator
K173439 · JOQ
Fischer Medical
Cardiovascular · 146d
Cleared Mar 29, 2018
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
K173533 · EZL
Poiesis Medical, LLC
Gastroenterology & Urology · 134d
Cleared Mar 29, 2018
NaviCross 0.018
K173799 · DQY
Terumo Corporation
Cardiovascular · 105d
Cleared Mar 29, 2018
CorPath GRX System
K180517 · DXX
Corindus, Inc.
Cardiovascular · 30d
Cleared Mar 29, 2018
NovoStitch Pro Meniscal Repair System
K180531 · GAT
Ceterix Orthopaedics, Inc.
General & Plastic Surgery · 29d
Cleared Mar 29, 2018
Voluson P6 and Voluson P8
K180535 · IYN
Ge Healthcare
Radiology · 29d
Cleared Mar 28, 2018
Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket,...
K171969 · LQR
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 271d
Cleared Mar 28, 2018
CoreHip® System
K172235 · LZO
Aesculap Implants Systems, LLC
Orthopedic · 246d
Cleared Mar 28, 2018
ROSA BRAIN (v3.0.0.5)
K172444 · HAW
Medtech S.A
Neurology · 226d
Cleared Mar 28, 2018
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
K172627 · LCX
Runbio Biotech Co.,Ltd
Chemistry · 208d
Cleared Mar 28, 2018
Concentrix MX-AC High-Speed Handpiece
K173465 · EFB
Dentalez, Inc.
Dental · 140d
Cleared Mar 28, 2018
GYN-Pump PH304
K173489 · HIG
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 135d
Cleared Mar 28, 2018
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
K173591 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 127d
Cleared Mar 28, 2018
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2
K173727 · EOQ
Ambu A/S
Ear, Nose, Throat · 113d
Cleared Mar 28, 2018
Genesys Spine AIS-C Cervical Anchored Interbody System
K180056 · OVE
Genesys Spine
Orthopedic · 79d
Cleared Mar 28, 2018
Mission Lipid Panel Monitoring System
K180504 · CHH
ACON Laboratories, Inc.
Chemistry · 30d
Cleared Mar 28, 2018
PressureWire X
K180558 · DXO
St. Jude Medical (Now Part of Abbott...
Cardiovascular · 27d
Cleared Mar 27, 2018
Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood...
K170605 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 391d
Cleared Mar 27, 2018
Pulse Oximeter
K171241 · DQA
Hunan Accurate Bio-Medical Technology...
Anesthesiology · 334d
Cleared Mar 27, 2018
Mpact® 3D Metal™ Implants and Augments 3D Metal™
K171966 · LPH
Medacta International S.A.
Orthopedic · 270d
Cleared Mar 27, 2018
FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO®...
K172269 · PML
Globus Medical, Inc.
Orthopedic · 242d
Cleared Mar 27, 2018
NES Reprocessed RF Stylet (RFS)
K173214 · NUJ
Northeast Scientific, Inc. (Nes)
General & Plastic Surgery · 176d