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
25585–25608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 2018
OSSEODUO Shaver and Drill System
K173066 · HBC
Bien-Air Surgery SA
Neurology · 266d
Cleared Jun 22, 2018
Advance Biliary Balloon Catheter
K173414 · GCA
Cook Incorporated
Gastroenterology & Urology · 233d
Cleared Jun 22, 2018
Shear Wave Quantificational Ultrasound Diagnostic System
K173595 · IYO
Wuxi Hisky Medical Technologies Co.,...
Radiology · 213d
Cleared Jun 22, 2018
gel-e Flex
K180152 · QSY
Gel-E, Inc.
General & Plastic Surgery · 154d
Cleared Jun 22, 2018
Life Spine Lumbar Fixation System (SENTRY)
K180166 · KWQ
Life Spine, Inc.
Orthopedic · 151d
Cleared Jun 22, 2018
MIS Internal Hex Dental Implant System
K180282 · DZE
Mis Implants Technologies , Ltd.
Dental · 142d
Cleared Jun 22, 2018
Wireless Pain Relieve Device
K180331 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 136d
Cleared Jun 22, 2018
A3 Total Knee System
K180493 · JWH
Beijing AK Medical Co., Ltd.
Orthopedic · 116d
Cleared Jun 22, 2018
BioPlex 2200 25-OH Vitamin D Kit
K180577 · MRG
Bio-Rad Laboratories
Chemistry · 109d
Cleared Jun 22, 2018
UV Lamps for Sunlamp Products
K180581 · LEJ
Feilo Sylvania Germany GmbH
General & Plastic Surgery · 113d
Cleared Jun 22, 2018
Knotless SutureTak Anchors
K180594 · MAI
Arthrex, Inc.
Orthopedic · 108d
Cleared Jun 22, 2018
iSLEEVE Introducer Set
K180785 · DYB
Boston Scientific Corporation
Cardiovascular · 88d
Cleared Jun 22, 2018
MIM - SPECTRA Quant
K180815 · LLZ
Mim Software, Inc.
Radiology · 85d
Cleared Jun 22, 2018
VaPro 2 Intermittent Catheter
K180824 · GBM
Hollister Incorporated
Gastroenterology & Urology · 84d
Cleared Jun 22, 2018
Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo...
K180950 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 72d
Cleared Jun 22, 2018
IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE...
K181051 · KRD
Shape Memory Medical
Cardiovascular · 63d
Cleared Jun 22, 2018
OSOM Mono Test
K181436 · KTN
SEKISUI Diagnostics, LLC
Microbiology · 21d
Cleared Jun 22, 2018
Elecsys CA 15-3 II
K181492 · MOI
Roche Diagnostics
Immunology · 16d
Cleared Jun 21, 2018
HOMED Mesh Nebulizer
K170886 · CAF
Shenzhen Homed Medical Device Co., Ltd.
Anesthesiology · 451d
Cleared Jun 21, 2018
Kopac Sterile Needle
K172483 · FMI
Poonglim Pharmatech, Inc.
General Hospital · 309d
Cleared Jun 21, 2018
DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional,...
K172975 · JDQ
Synthes (Usa) Products, LLC / Depuy...
Orthopedic · 267d
Cleared Jun 21, 2018
BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
K173028 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 266d
Cleared Jun 21, 2018
0.9% Sodium Chloride Injection, USP
K173348 · NGT
Medline Industries, Inc.
General Hospital · 239d
Cleared Jun 21, 2018
Integra TITAN Reverse Shoulder System
K173717 · PHX
Integra LifeSciences Corporation
Orthopedic · 198d