Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
36289–36312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2014
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner...
K142235 · DQY
St Jude Medical
Cardiovascular · 127d
Cleared Dec 18, 2014
CPS Direct MediGuide Enabled outer catheter
K142239 · DQY
St Jude Medical
Cardiovascular · 127d
Cleared Dec 18, 2014
SMART LABEL, PROPOFOL
K142333 · MRZ
American I.V. Products, Inc. Dba Aiv,...
General Hospital · 119d
Cleared Dec 18, 2014
NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K142342 · LYZ
Nacrous Plastic Co., Ltd.
General Hospital · 119d
Cleared Dec 18, 2014
Interspinous Plate System
K142378 · PEK
Precision Spine, Inc.
Orthopedic · 114d
Cleared Dec 18, 2014
Quickie, Zippie
K142457 · ITI
Sunrise Medical (Us), LLC
Physical Medicine · 107d
Cleared Dec 18, 2014
Bio2 CLM BG Bioactive Scaffold
K142463 · MQV
Bio2 Technologies, Inc.
Orthopedic · 107d
Cleared Dec 18, 2014
SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura)...
K142488 · MAX
Seaspine, Inc.
Orthopedic · 105d
Cleared Dec 18, 2014
UniWeb 8.0
K142514 · LLZ
Ebm Technologies Incorporated
Radiology · 101d
Cleared Dec 18, 2014
Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink )
K142570 · LYZ
Ever Light Plastic Products Co., Ltd.
General Hospital · 97d
Cleared Dec 18, 2014
Nitrile Powder Free Examination Glove (Blue)
K142588 · LZA
Hartalega Sdn Bhd
General Hospital · 94d
Cleared Dec 18, 2014
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
K142609 · LFG
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 93d
Cleared Dec 18, 2014
Snap Insulin Pump System
K142619 · LZG
Asante Solutions, Inc.
General Hospital · 93d
Cleared Dec 18, 2014
Hermes Medical Imaging Suite v5.5
K142631 · KPS
Hermes Medical Solutions AB
Radiology · 92d
Cleared Dec 18, 2014
StimPad OTC
K142686 · NUH
Aemed, Inc.
Neurology · 87d
Cleared Dec 18, 2014
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS,...
K142702 · DWJ
Medivance, Inc.
Cardiovascular · 87d
Cleared Dec 18, 2014
MAS PLIF Fixation system
K142737 · NKB
Nu Vasive, Incorporated
Orthopedic · 86d
Cleared Dec 18, 2014
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin...
K142805 · LZA
Hartalega Sdb. Bhd.
General Hospital · 80d
Cleared Dec 18, 2014
Echo Bi-Metric Microplasty Hip System
K143009 · LPH
Biomet, Inc.
Orthopedic · 59d
Cleared Dec 18, 2014
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050 · HRS
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Dec 18, 2014
LT-300 Video Colposcope
K143119 · HEX
Lutech Industries, Inc.
Obstetrics & Gynecology · 49d
Cleared Dec 18, 2014
Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax...
K143186 · OCX
Erbe USA, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 18, 2014
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
K143307 · MSS
Rayner Intraocular Lenses , Ltd.
Ophthalmic · 30d
Cleared Dec 18, 2014
Threshold Pedicular Fixation System
K143403 · NKB
Spineology, Inc.
Orthopedic · 20d