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
19033–19056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2020
Xeleris V Processing and Review Systems
K201103 · LLZ
Ge Healthcare
Radiology · 154d
Cleared Sep 25, 2020
ImageSPECTRUM
K201273 · NFJ
Canon, Inc.
Ophthalmic · 136d
Cleared Sep 25, 2020
Ventilator, Non-continuous (Respirator)
K201439 · BZD
Respironics, Inc.
Anesthesiology · 116d
Cleared Sep 25, 2020
Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue...
K201756 · HIH
Stryker Sustainability Solutions
Obstetrics & Gynecology · 88d
Cleared Sep 25, 2020
Light Cure Dental Adhesive
K201787 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 87d
Cleared Sep 25, 2020
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System,...
K201820 · MAX
Nu Vasive, Incorporated
Orthopedic · 86d
Cleared Sep 25, 2020
Honorst Implant System
K202039 · DZE
Medimecca Co., Ltd.
Dental · 64d
Cleared Sep 25, 2020
Surgical Face Mask
K202277 · FXX
Jiangxi 3l Medical Products Group...
General Hospital · 45d
Cleared Sep 25, 2020
BD Preset Syringe & BD A-Line Syringe
K202446 · JKA
Becton, Dickinson and Company
Chemistry · 30d
Cleared Sep 25, 2020
Synchro SELECT Guidewire
K202522 · MOF
Stryker Neurovascular
Neurology · 24d
Cleared Sep 25, 2020
Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test...
K202567 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 21d
Cleared Sep 24, 2020
Cavetto-SA Cervical Cage System
K200115 · OVE
Neurostructures, Inc.
Orthopedic · 247d
Cleared Sep 24, 2020
RayStation
K200569 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 204d
Cleared Sep 24, 2020
Straumann BoneCeramic
K201051 · LYC
Institut Straumann AG
Dental · 156d
Cleared Sep 24, 2020
Dermal Cooling System
K201260 · GEH
R2 Technologies, Inc.
General & Plastic Surgery · 136d
Cleared Sep 24, 2020
A-Silicone for Bite Registration
K201684 · ELW
Shandong Huge Dental Material...
Dental · 94d
Cleared Sep 24, 2020
Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable...
K201770 · DQA
Masimo Corporation
Anesthesiology · 87d
Cleared Sep 24, 2020
EndoGI S-Path Biliary Stent System
K202477 · FGE
Endo GI Medical
Gastroenterology & Urology · 27d
Cleared Sep 24, 2020
Cordera Hip System
K202484 · LPH
Conformis, Inc.
Orthopedic · 24d
Cleared Sep 24, 2020
GXR-Series Diagnostic X-Ray System
K202572 · KPR
DRGEM Corporation
Radiology · 20d
Cleared Sep 23, 2020
Nerve and Muscle Stimulator
K193276 · GZI
Shenzhen Xft Medical Limited
Neurology · 302d
Cleared Sep 23, 2020
Pulse Oximeter
K200414 · DQA
Shenzhen Aeon Technology Co., Ltd.
Anesthesiology · 217d
Cleared Sep 23, 2020
Boston One Step Liquid Enzymatic Cleaner
K200416 · MRC
Bausch & Lomb, Incorporated
Ophthalmic · 216d
Cleared Sep 23, 2020
Halo AF Detection System
K201208 · DXH
Livmor
Cardiovascular · 141d